Omylclo

Package leaflet: Information for the user

Omlyclo 75 mg injectable solution in pre-filled syringe

omalizumab
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Omlyclo is and what it is used for
2. What you need to know before using Omlyclo
3. How to use Omlyclo
4. Possible side effects
5. How to store Omlyclo
6. Contents of the pack and other information

1. What Omlyclo is and what it is used for

Omlyclo contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
proteins naturally produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Omlyclo is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal cavities) with nasal polyps

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic
asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma
medicines, but in whom asthma symptoms are not well controlled by medications such as high-dose
inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age)
who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in whom
symptoms are not well controlled by these medicines. Nasal polyps are small growths on the nasal
mucosa. Omlyclo helps reduce the size of polyps and improves symptoms, including nasal congestion,
loss of sense of smell, mucus in the back of the throat, and runny nose.
Omlyclo works by blocking a substance known as immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and
chronic rhinosinusitis with nasal polyps.

2. What you need to know before using Omlyclo

Do not use Omlyclo

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6) (see the special warnings at the end of this section under “Omlyclo contains polysorbate”).
• if you think you may be allergic to any of the ingredients, inform your doctor as you must not use Omlyclo.

Warnings and precautions
Talk to your doctor before using Omlyclo:

• if you have kidney or liver problems;
• if you have a condition in which your immune system attacks part of your body (autoimmune disease);
• if you plan to travel to areas where parasitic infections are common, as Omlyclo may reduce resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, following a medicine, an insect sting, or food.

Omlyclo does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Omlyclo
must not be used to treat these symptoms.
Do not use Omlyclo to prevent or treat other allergic conditions such as sudden allergic reactions,
hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease),
food allergy, eczema, or hay fever, as Omlyclo has not been studied in these conditions.
Be alert to signs of allergic reactions and other serious side effects
Omlyclo may potentially cause serious side effects. You should be aware of the signs of these
conditions while using Omlyclo. Seek immediate medical help if you notice any sign of a severe
allergic reaction or other serious side effects. These signs are listed in section 4 under “Serious side effects”.
Before you self-inject Omlyclo or before someone who is not a healthcare professional administers the injection,
it is important that you receive instructions from your doctor on how to recognize early symptoms of severe
allergic reactions and how to manage these reactions if they occur (see section 3, “How to use Omlyclo”).
Most severe allergic reactions occur within the first 3 doses of Omlyclo.
Children and adolescents
Allergic asthma
Omlyclo is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Omlyclo is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Other medicines and Omlyclo
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines to treat a parasitic infection, as Omlyclo may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor
before using this medicine. Your doctor will discuss with you the benefits and potential risks of using
this medicine during pregnancy.
If you become pregnant while being treated with Omlyclo, inform your doctor immediately.
Omlyclo may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor
before using this medicine.
Driving and using machines
It is unlikely that Omlyclo will affect your ability to drive or operate machinery.
Omlyclo contains polysorbate
This medicine contains 0.20 mg of polysorbate 20 per pre-filled syringe, equivalent to 0.40 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you or your child have known allergies.

3. How to use Omlyclo

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor, nurse, or pharmacist.

How Omlyclo is used
Omlyclo is administered as an injection under the skin (known as a subcutaneous injection).

• You and your doctor will decide whether you can self-inject Omlyclo. The first 3 doses are always administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (for example, a relative) may also administer the Omlyclo injection after receiving appropriate training.

For detailed instructions on how to inject Omlyclo, please read the “Instructions for the use of Omlyclo pre-filled syringe” at the end of this leaflet.

Instructions on how to recognize severe allergic reactions
It is also important that you do not self-inject Omlyclo until you have been trained by your doctor or nurse on:

• how to recognize early signs and symptoms of severe allergic reactions;
• what to do if symptoms occur. For further information on the early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Your doctor will determine the dose of Omlyclo you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE levels.
You will need between 1 and 4 injections at a time. You will require injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Omlyclo. Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting treatment with Omlyclo. In patients with nasal polyps, effects are typically seen after 4 weeks of treatment. In asthmatic patients, the full effect is usually achieved after 12–16 weeks.

Use in children and adolescents
Allergic asthma
Omlyclo can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta agonists. Your doctor will determine the amount of Omlyclo needed and how often it should be administered. This will depend on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE levels.
Self-administration of Omlyclo is not permitted for children (aged 6 to 11 years). However, if the doctor considers it appropriate, the Omlyclo injection may be administered by a caregiver after receiving adequate training.

Chronic rhinosinusitis with nasal polyps
Omlyclo must not be used in children and adolescents under 18 years of age.

If you miss a dose of Omlyclo
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Omlyclo, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should administer the next dose.

If you stop treatment with Omlyclo
Do not stop treatment with Omlyclo unless instructed by your doctor. Stopping or interrupting treatment with Omlyclo may cause symptoms to return.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects caused by Omlyclo are usually mild or moderate in severity, but occasionally they can be serious.

Serious side effects:

If you notice any of the following symptoms, seek immediate medical attention:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Omlyclo, you may have a higher risk of developing a severe allergic reaction following use of Omlyclo.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood or lymph vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• reactions at the injection site such as pain, swelling, itching and redness
• pain in the upper part of the stomach
• headache (very common in children)
• feeling dizzy
• joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness in the hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omlyclo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled syringe may be stored at room temperature (25 °C) for a total period of 7 days.
• Store in the original packaging to protect the medicine from light.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Do not use if the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What Omlyclo contains

• The active substance is omalizumab. One pre-filled syringe of 0.5 mL solution contains 75 mg of omalizumab.
• The other components are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20 (E 432), and water for injections.

Description of the appearance of Omlyclo and contents of the pack
Omlyclo solution for injection is a clear or slightly opalescent, colourless to pale yellowish-brown solution contained in a pre-filled syringe.
Omlyclo 75 mg solution for injection is available in packs containing 1 pre-filled syringe and in multiple packs containing 3 (3 x 1) pre-filled syringes.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest,
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot,
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: +32 1528 7418 Tel.: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Tel.: +36 1 231 0493 Tél/Tel: +32 1528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd.
[email protected] Tel: +356 2093 9800
Tlf: +45 3535 2989

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 303 464 941 50 Tel: +31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
CELLTRION FARMACEUTICA (ESPAÑA) S.L. Astro-Pharma GmbH
Tel: +34 910 498 478 Tel: +43 1 97 99 860
[email protected]

Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 - 120 Tel.: +36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL LDA
Tél.: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tālr.: +36 1 231 0493

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF OMLYCLO PRE-FILLED SYRINGE

Read and follow the instructions for use that come with the Omlyclo pre-filled syringe before starting to use it and each time you receive a new prescription. There may be new information. Before using the Omlyclo pre-filled syringe for the first time, make sure your healthcare provider shows you the correct way to use it.

Children (aged 6 to 11 years) must not self-inject with the Omlyclo pre-filled syringe on their own. However, if considered appropriate by the doctor, the injection may be administered by a caregiver after receiving adequate training.

Parts of the pre-filled syringe (see Figure A)

After use
Plunger

Grip
Viewing
window

Medicine
Needle
Safety
shield
Needle
Cap
Figure A

Choose the correct pre-filled syringe or combination of pre-filled syringes
Omlyclo pre-filled syringes are available in 3 dosage strengths (see Figure B). These
instructions apply to all dosage strengths.

75 mg/0.5 mL
Yellow plunger
150 mg/1 mL
Blue plunger
300 mg/2 mL
White plunger
Figure B

Your prescribed dose may require more than one injection. The following dosing table (Figure C) shows the combinations of pre-filled syringes needed to administer the full dose. Check the label on the Omlyclo carton to ensure you have received the correct pre-filled syringe or combination of pre-filled syringes for your prescribed dose. If your prescribed dose requires more than one injection, administer all injections for the prescribed dose consecutively, one after the other. If you have any doubts, consult your healthcare provider.

Consult your healthcare provider if you have any questions about the dosing table.
Dosing table
Pre-filled syringes required
Dose
Yellow Blue White
(mg)
(75 mg) (150 mg) (300 mg)

150

225 +
300
(12 years and older)
300

(children under 12 years of age)
375
+
(12 years and older)
375

(children under 12 years of age)
450
+
(12 years and older)

450
(children under 12 years of age)
525

(12 years and older)
525

(children under 12 years of age)
600
(12 years and older)

600
(children under 12 years of age)
Figure C
Note: Your healthcare provider may prescribe a different combination of pre-filled syringes for your complete dose.
Important information to know before using Omlyclo

• Omlyclo is intended for subcutaneous injection only (inject directly into the fatty layer beneath the skin).
• The pre-filled syringe is equipped with a safety shield that automatically activates to cover the needle after injection. The safety shield helps prevent needlestick injuries, protecting anyone handling the pre-filled syringe after use.
• Do not open the sealed carton until you are ready to use the pre-filled syringe.
• Do not use if the carton or the pre-filled syringe is damaged or appears tampered with.
• Do not remove the cap until you are ready to administer the injection.
• Do not use if the pre-filled syringe has fallen on a hard surface or has been dropped after removing the cap.
• Do not reuse the same pre-filled syringe.
• Do not leave the pre-filled syringe unattended.
• Do not attempt to disassemble the pre-filled syringe.
• Do not pull back the plunger.

How to store Omlyclo?

• Store unused pre-filled syringes in their original carton in the refrigerator at 2 °C to 8 °C.
• Do not remove the pre-filled syringe from the original carton during storage.
• Keep the pre-filled syringe in the original carton until ready to use to protect it from light.
• Do not freeze.
• Do not use the pre-filled syringe if it has been frozen.
• Prior to administering an injection, the carton may be removed from and returned to the refrigerator if necessary. The total cumulative time outside the refrigerator must not exceed 7 days. If the pre-filled syringe is exposed to temperatures above 25 °C, do not use it and dispose of it in a sharps disposal container.
• Keep the pre-filled syringe, the sharps disposal container, and all medicines out of the sight and reach of children. The pre-filled syringe contains small parts.

Preparing for injection

1. Remove the carton containing the pre-filled syringe

from the refrigerator and allow the
pre-filled syringe to reach room
temperature.
a. If more than 1 pre-filled syringe is
required to administer the prescribed dose,

(see Figure C), remove all necessary cartons
from the refrigerator at the same time,
30–45 minutes beforehand (each carton
contains 1 pre-filled syringe). The
following procedure must be followed for
each pre-filled syringe.
b. Set the still-closed carton aside on a flat,
clean surface for at least 30–45 minutes to
allow the pre-filled syringe to warm up.
Leave the pre-filled syringe inside the
carton to protect it from light (see Figure D).
Figure D Do not heat the pre-filled syringe using
other heat sources such as hot water or a
microwave.
If the pre-filled syringe does not reach room
temperature, the injection may be uncomfortable
and it may be difficult to push the plunger.

2. Gather the injection supplies

(see Figure E).
Case containing the pre-filled
syringe
Not included in the case:

• Alcohol swab

• Cotton ball or gauze

• Adhesive bandage

• Sharps disposal container

Note: More than 1 pre-filled syringe may be
required for the prescribed dose. For
further information, see the following
dosage table (see Figure C).
Each case contains 1 pre-filled syringe.
Figure E

3. Check the expiration date shown

on the carton (see Figure F).
Do not use if the expiration date has
been exceeded.
If the expiration date has been exceeded,
dispose of the carton safely in a
sharps disposal container (see step 16.
Dispose of the pre-filled syringe ) and
contact your healthcare provider.
Figure F

4. Wash your hands.

a. Wash your hands with soap and water and
dry them thoroughly (see Figure G).
Figure G

5. Remove the pre-filled syringe

from the carton.
a. Open the carton.
b. Grasp the body of the syringe and remove
the pre-filled syringe from the carton
(see Figure H).
Do not touch the plunger or the cap
when removing the pre-filled syringe
from the carton.
Figure H

6. Inspect the prefilled syringe.

a. Check the prefilled syringe and
make sure it contains the correct medicine

(Omlyclo) and the correct dosage.
b. Examine the prefilled syringe to
ensure it is not broken or damaged.
Do not use if the prefilled syringe is
damaged or appears tampered with.
c. Check the expiration date shown
on the label of the prefilled syringe
(see Figure I).
Do not use if the expiration date has
been exceeded.
Note: If the expiration date is not visible in the
inspection window, the inner barrel of the prefilled syringe
can be rotated until the expiration date
Figure I
becomes visible.

7. Inspect the medicine.

a. Examine the medicine to make sure the
liquid is from clear to slightly
opalescent, from colorless to pale yellow-brown,
and free of particles (see Figure J).
Do not use the pre-filled syringe if the
liquid has changed color, is distinctly opalescent, or
contains particles.
You may notice air bubbles in the
liquid. This is normal.
Do not attempt to remove the air
bubbles.
b. If the medicine does not match the
description provided or if the expiration date has
passed, safely dispose of the
Figure J
pre-filled syringe in a sharps disposal container
(see step 16) and contact your
healthcare provider.

8. Choosing an injection site (see

Figure K).
a. If self-administered, the injection may be given:
on the front of the thighs;
in the lower abdomen, except for

the 5 cm area around
the navel.
b. If administered by a caregiver or healthcare professional, the injection may be given:
on the outer area of the arms;
on the front of the thighs;
in the lower abdomen, except for
the 5 cm area around
the navel.
Do not administer the injection into moles,
scars, bruises, or in areas where the
skin is tender, red, hardened, or not intact.
Do not inject through clothing. The injection site must be
Figure K an exposed and clean area of skin.
If the prescribed dose requires more than
1 injection, administer the injections at sites
at least 2 cm apart from each other.

9. Clean the injection site.

a. Clean the injection site with an alcohol swab using circular motions (see Figure L).
b. Allow the skin to dry for 10 seconds before administering the injection.
Do not wave or blow on the cleaned area.
Do not touch the injection site again before giving the injection.
Figure L
Administration of the injection

10. Remove the cap.

a. Hold the body of the pre-filled syringe with one hand.
b. With the other hand, gently pull off the cap in a straight line (see Figure M).
Do not remove the cap until you are ready to administer the injection.
Do not twist the cap.
Do not hold, push, or pull the plunger while removing the cap.
You may notice a few drops of liquid at the tip of the needle. This is normal.
c. Immediately dispose of the cap in a sharps disposal container (see step 16. Disposal of the pre-filled syringe and Figure M).
Do not reinsert the cap onto the pre-filled syringe.
Once the cap has been removed, do not touch the needle and avoid contact with any surface.

**Figure M** **Figure M**

11. Insert the pre-filled syringe into the

injection site.
a. With one hand, gently pinch a skin
fold at the injection site. Hold the skin
fold firmly until the injection is
complete.
Note: This step is important to ensure
that the injection is delivered under the
skin (into the fatty tissue) and not deeper
(into the muscle).

b. Insert the needle completely into the
skin fold at an angle of approximately
45 degrees with a quick, firm motion
(see Figure N).
Note: It is important to maintain the
correct angle to ensure that the medicine
is administered under the skin (into the
fatty tissue); otherwise, the injection may
be uncomfortable and the medicine may
not work properly.
Figure N
Do not touch the plunger while
inserting the needle into the skin.
Do not insert the needle through clothing.
Once the needle is inserted, hold the
pre-filled syringe firmly in place and
do not change the angle of the
injection or reinsert the needle. The
patient must remain still and avoid
sudden movements during the injection.

12. Administer the injection.

a. Slowly push the plunger all the way

to the end of its travel, until the
entire dose of medication has been
administered and the pre-filled syringe
is empty (see Figure O).
Do not change the position of the
pre-filled syringe after starting the
injection.
If the plunger is not fully depressed,
the safety shield will not extend to
cover the needle upon removal.
Figure O

13. Remove the prefilled syringe from the injection site.

of injection.
a. When the prefilled syringe is empty,
slowly lift your thumb off the

plunger until the needle is
completely covered by the safety
shield (see Figure P).
If the needle does not cover automatically,
carefully remove the prefilled syringe from
the skin and dispose of it in a sharps disposal
container (see step 16. Disposal of the
prefilled syringe).
b. Remove the prefilled syringe from the
injection site and release the skin fold.
Mild bleeding may occur (see step 14.
Care of the injection site).
Do not reuse the prefilled syringe.

14. Care of the injection site.

a. If bleeding occurs or a drop of liquid is present at the injection site,
treat the injection site by gently pressing, without rubbing, a cotton ball or
gauze pad against the site, and, if necessary, apply a plaster.
Do not rub the injection site.
b. If the medicine comes into contact with the skin, wash the area that has come into
contact with the medicine with water.

15. If the prescribed dose requires more than one injection:

a. Dispose of the used prefilled syringe as described in step 16. Disposal of the prefilled syringe.
b. Repeat steps 1 to 14 for the next injection, using a new prefilled syringe.
Administer the injections at sites at least 2 cm apart from each other.
Give all injections required for the prescribed dose consecutively, one after the other.
If you have any doubts, consult your healthcare provider.
After the injection

16. Disposal of the pre-filled syringe.

a. Place the used pre-filled syringe into a
sharps disposal container immediately after use
(see Figure Q).

The Omlyclo pre-filled syringe is
for single use only and must not be reused.
Do not attempt to re-cover the needle with the
syringe cap.
Do not dispose of (throw away) the pre-filled
syringe in household waste.
If a sharps disposal container is not available,
a puncture-resistant, closable household container
may be used.
Figure Q
Ask your doctor or pharmacist for information
on the proper disposal of the sharps disposal container.
Disposal may be subject to local regulations.

Package leaflet: Information for the user

Omlyclo 75 mg solution for injection in a pre-filled pen

omalizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Omlyclo is and what it is used for
2. What you need to know before using Omlyclo
3. How to use Omlyclo
4. Possible side effects
5. How to store Omlyclo
6. Contents of the pack and other information

1. What Omlyclo is and what it is used for

Omlyclo contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
proteins naturally produced by the body. It belongs to a class of medicines called monoclonal antibodies.
Omlyclo is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma medications, but in whom asthma symptoms are not well controlled by medications such as high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age) who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in whom symptoms are not well controlled by these medicines. Nasal polyps are small growths on the lining of the nose. Omlyclo helps reduce the size of nasal polyps and improves symptoms, including nasal congestion, loss of sense of smell, mucus in the back of the throat, and runny nose.
Omlyclo works by blocking a substance known as immunoglobulin E (IgE), which is produced by the body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and chronic rhinosinusitis with nasal polyps.

2. What you need to know before using Omlyclo

Do not use Omlyclo

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6) (See special warnings at the end of this section under “Omlyclo contains polysorbate”).
• If you think you are allergic to any of the ingredients, inform your doctor, as you must not use Omlyclo.

Warnings and precautions
Talk to your doctor before using Omlyclo:

• if you have kidney or liver problems;
• if you have a disorder in which your immune system attacks part of your body (autoimmune disease);
• if you plan to travel to areas where infections caused by parasites are common, because Omlyclo may reduce resistance to these infections;
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example due to a medicine, an insect sting, or food.

Omlyclo does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Omlyclo
must not be used to treat these symptoms.
Do not use Omlyclo to prevent or treat other allergic conditions such as sudden allergic reactions,
hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease),
food allergy, eczema, or hay fever, as Omlyclo has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious adverse effects
Omlyclo may potentially cause serious adverse effects. You should be alert for signs of these
conditions while using Omlyclo. Seek immediate medical help if you notice any signs of a severe
allergic reaction or other serious adverse effects. These signs are listed in section 4 under “Serious
adverse effects”.
Before you self-inject Omlyclo or before someone who is not a healthcare professional administers the
injection, it is important that you receive instructions from your doctor on how to recognize early
symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3,
“How to use Omlyclo”). Most severe allergic reactions occur within the first 3 doses of Omlyclo.
Children and adolescents
Allergic asthma
Omlyclo is not recommended for children under 6 years of age. Use in children under 6 years has not
been studied.
Chronic rhinosinusitis with nasal polyps
Omlyclo is not recommended for children and adolescents under 18 years of age. Use in children and
adolescents under 18 years has not been studied.
Other medicines and Omlyclo
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other
medicines.
This is especially important if you are taking:

• medicines for the treatment of an infection caused by a parasite, as Omlyclo may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor for
advice before using this medicine. Your doctor will discuss with you the benefits and potential risks of
using this medicine during pregnancy.
If you become pregnant while being treated with Omlyclo, inform your doctor immediately.
Omlyclo may pass into breast milk. If you are breastfeeding or planning to breastfeed, ask your doctor
for advice before using this medicine.
Driving and using machines
It is unlikely that Omlyclo will affect your ability to drive or use machines.
Omlyclo contains polysorbate
This medicine contains 0.20 mg of polysorbate 20 per pre-filled pen, equivalent to 0.40 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you or the child has known allergies.

3. How to use Omlyclo

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your
doctor, nurse, or pharmacist.
How to use Omlyclo
Omlyclo is administered as an injection under the skin (known as a subcutaneous injection).
Omlyclo injection

• You and your doctor will decide whether you can self-inject Omlyclo. The first 3 doses must always be administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (e.g. a family member) may also administer the Omlyclo injection after receiving appropriate training.

For detailed instructions on how to inject Omlyclo, please read the “Instructions for using the Omlyclo pre-filled pen” at the end of this leaflet.
Instructions on how to recognize severe allergic reactions
It is also important that you do not self-inject Omlyclo until you have been trained by your doctor or
nurse on:

• how to recognize early signs and symptoms of severe allergic reactions;
• what to do if symptoms occur. For further information on early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Your doctor will determine the dose of Omlyclo you need and how often you should use it. This depends
on your body weight and the results of a blood test performed before starting treatment to measure your
IgE levels.
You may need between 1 and 4 injections at a time. You will need injections every two weeks or every
four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Omlyclo.
Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting treatment with Omlyclo. In patients with
nasal polyps, effects are typically seen after 4 weeks of treatment. In patients with asthma, full effect is
usually achieved after 12–16 weeks.
Use in children and adolescents
Allergic asthma
Omlyclo can be used in children and adolescents aged 6 years and older who are already taking asthma
medication but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids
and inhaled beta agonists. Your doctor will determine the dose of Omlyclo required and how often it
should be administered. This will depend on the child’s body weight and the results of a blood test
performed before starting treatment to measure the child’s IgE levels.
Self-administration of Omlyclo is not permitted for children (aged 6 to 11 years). However, if the doctor
considers it appropriate, the Omlyclo injection may be given by a caregiver after receiving proper
training.
The Omlyclo pre-filled pens are not intended for use in children under 12 years of age. The 75 mg
pre-filled syringe and the 150 mg pre-filled syringe of Omlyclo may be used in children aged 6 to 11
years with allergic asthma.
Chronic rhinosinusitis with nasal polyps
Omlyclo must not be used in children and adolescents under 18 years of age.
If you miss a dose of Omlyclo
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Omlyclo, inject the missed dose as soon as you remember. Then
contact your doctor to determine when you should receive the next dose.
If you stop treatment with Omlyclo
Do not stop treatment with Omlyclo unless instructed by your doctor. Stopping or interrupting
treatment with Omlyclo may cause your symptoms to return.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects caused by Omlyclo are usually mild or moderate in severity, but occasionally they may be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical attention:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) unrelated to Omlyclo, you may have an increased risk of developing a severe allergic reaction following use of Omlyclo.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, skin rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or rash around blood or lymph vessels, elevated levels of a specific type of white blood cell (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• reactions at the injection site such as pain, swelling, itching, and redness
• pain in the upper abdomen
• headache (very common in children)
• dizziness
• joint pain (arthralgia)

Uncommon (may affect up to 1 in 100 people)

• feeling drowsy or tired
• tingling or numbness in hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omlyclo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled pen may be stored for a total period of 7 days at room temperature (25 °C).
• Store in the original packaging to protect the medicine from light.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Do not use if the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What Omlyclo contains

• The active substance is omalizumab. One pre-filled pen containing 0.5 mL of solution contains 75 mg of omalizumab.
• The other components are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20 (E 432), and water for injections.

Description of the appearance of Omlyclo and contents of the pack
Omlyclo solution for injection is a clear or slightly opalescent, colourless to pale yellowish-brown solution contained in a pre-filled pen.
Omlyclo 75 mg solution for injection is available in a pack containing 1 pre-filled pen and in multiple packs containing 3 (3 x 1) pre-filled pens.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest,
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot,
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1 528 7418 Tel.: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Teл.: +36 1 231 0493 Tél/Tel: + 32 1 528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd.
[email protected] Tel: +356 2093 9800
Tlf: +45 3535 2989

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 303 464 941 50 Tel: + 31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
CELLTRION FARMACEUTICA (ESPAÑA) S.L. Astro-Pharma GmbH
Tel: +34 910 498 478 Tel: +43 1 97 99 860
[email protected]

Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 - 120 Tel.: +36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL LDA
Tél.: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tālr.: +36 1 231 0493

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF OMLYCLO PRE-FILLED PEN

Read and follow the instructions for use that come with the Omlyclo pre-filled pen before
starting to use it and each time you receive a new prescription. There may be new
information. Before using Omlyclo, make sure a healthcare professional shows you the correct way
to use it.
Adolescents aged 12 years and older: injection with the Omlyclo pre-filled pen may
be self-administered under the supervision of an adult. The Omlyclo pre-filled pen (all doses)
is intended for use in adults and adolescents aged 12 years and older.
Parts of the pre-filled pen (see Figure A)

Before use After use
Expiry
date
Body
Yellow indicator
“injection
complete”
Observation window
Needle cap
Red needle cap
(needle internally covered)
Yellow cap Yellow cap
Figure A
Select the correct pre-filled pen or combination of pre-filled pens
Omlyclo pre-filled pens are available in 2 doses (see Figure B). These instructions
should be used for both doses.

This dose:
Other dose:
75 mg/0.5 mL 150 mg/1 mL
(yellow cap) (blue cap)
Figure B
The dose prescribed for you may require more than one injection. The following dosing table
( Figure C ) shows the combinations of pre-filled pens needed to administer the complete
dose. Check the label on the Omlyclo carton to ensure you have received the correct pre-filled pen or combination of pre-filled pens for your prescribed dose. If your prescribed dose requires more than one injection, administer all injections for the prescribed dose consecutively, one after the other. If you have any doubts, consult your healthcare professional.
Dosing table

Pre-filled pens required
Dose
(mg)

Yellow (75 mg/0.5 mL) Blue (150 mg/1 mL)
Figure C
Note: your healthcare professional may prescribe a different combination of pre-filled pens
for your complete dose.
How to store Omlyclo

• Store unused pre-filled pens in the original carton in the refrigerator at 2 °C to 8 °C.
• Before administering an injection, the carton may be removed from the refrigerator and returned if necessary. The total cumulative time outside the refrigerator must not exceed 7 days. If Omlyclo is exposed to temperatures above 25 °C, do not use Omlyclo and dispose of it in a sharps container.
• Do not remove the pre-filled pen from the original carton during storage.
• Keep the pre-filled pen away from direct sunlight.
• Do not freeze. Do not use the pre-filled pen if it has been frozen.
• Keep the pre-filled pen, the sharps disposal container, and all medicines out of the sight and reach of children.

Important information

• Do not use if the carton is damaged or visibly tampered with.
• Do not open the carton until you are ready to administer the injection.
• Do not use the pre-filled pen if it is damaged or visibly tampered with.
• Do not remove the cap of the pre-filled pen until the time of administering the Omlyclo injection.
• Do not use if the pre-filled pen has fallen on a hard surface or has been dropped after removing the cap.
• Never attempt to disassemble the pre-filled pen.
• Do not clean or touch the needle cap.

Preparing for injection

1. Remove the tray containing the pre-filled pen from the refrigerator.

1a. If more than one pre-filled pen is required to administer the prescribed dose (see Figure C), remove all necessary trays from the refrigerator at the same time (each tray contains 1 pre-filled pen). The following procedure must be followed for each pre-filled pen.

2. Gather the injection materials

(see Figure D).
Carrying case
2a. Carrying case containing the pre-filled
containing
Omlyclo
auto-injector pen
Alcohol swab Not included in the carrying case:

alcohol swab • alcohol swab
• cotton ball or gauze

• adhesive bandage

Cotton ball
or gauze • sharps disposal container

Note: More than one pre-filled pen of Omlyclo may be
Adhesive
required to administer the prescribed dose.
bandage
For further information, see the dosage table below
Sharps
( Figure C ). Each Omlyclo carrying case contains
disposal
one pre-filled pen.
container
Figure D

3. Check the expiration date printed

on the carton (see Figure E).

• Do not use the pre-filled pen if the expiration date has passed.
• If the expiration date has passed, dispose of the pre-filled pen in a
  sharps disposal container (see step 17) and contact
  your healthcare provider.
  Figure E

4. Allow the pre-filled pen

to reach room temperature.
4a. Place the case aside on a flat, clean surface
30-45 for 30-45 minutes so that the
pre-filled pen warms up to room temperature
minutes
without using any additional heat sources. Keep the pre-filled pen in the case to protect it from light (see Figure F).

• If the pre-filled pen does not reach room temperature, the injection may be uncomfortable.
• Do not warm the pre-filled pen using other heat sources such as hot water or a microwave.

Figure F

5. Open the carton.

5a. Wash your hands with soap and water.
5b. Remove the pre-filled pen from the carton
by holding it in the middle section (see Figure G).

• Do not turn the carton upside down to remove the pre-filled pen, as it may become damaged.
• Do not hold the pre-filled pen by the cap.
• Do not remove the cap until you are ready to administer the injection.

Figure G

6. Inspect the pre-filled pen

6a. Examine the viewing window of the
pre-filled pen to make sure the liquid is
clear to slightly opalescent, colourless to
pale yellow-brown, and free of particles.
Air bubbles may be seen in the liquid. This is
normal (see Figure H).

• Do not use the pre-filled pen if the liquid has changed colour, is distinctly cloudy, or contains particles.

6b. Check the expiry date of the pre-filled pen.

• Do not use the pre-filled pen if the expiry date has passed.

6c. Make sure the pre-filled pen shows no
signs of damage or appears to have been
tampered with.

• Do not use the pre-filled pen if it is damaged or appears to have been tampered with.

6d. If the medicine does not look as described or if the
expiry date has passed, dispose of the pre-filled pen safely in a sharps disposal container (see
step 17) and contact your healthcare provider.
Figure H

7. Choose an appropriate injection site

(see Figure I).
7a. The following injection site is recommended:
• the front of the thighs. The lower abdomen may also be used, but not
the area within 5 cm of the navel;
• the outer area of the upper arms (only if
the injection is administered by a caregiver or
healthcare professional).

• Do not self-administer the injection into the arm.
• Do not administer the injection into moles, scars, bruises, or areas where the skin appears painful, red, hard, or damaged.
• Do not inject through clothing.

The injection site must be an exposed and clean area of skin.

• If the prescribed dose requires more than
  1 injection, administer the injections at sites
  at least 2 cm apart.
  Figure I

8. Clean the injection site.

8a. Clean the injection site with an alcohol swab using circular motions,
and allow it to air dry for 10 seconds (see Figure J).

• Do not touch the injection site again before administering the injection.
• Do not fan or blow on the cleaned area.

Figure J
Administering the injection

9. Remove the cap.

9a. Hold the pre-filled pen firmly with one hand and remove the cap with the other hand (see Figure K).

• Do not rotate the cap.

• Do not reinsert the cap onto the pre-filled pen.

• You may notice a few drops of liquid at the needle tip. This is normal.

9b. Dispose of the cap in regular household waste.

• Do not clean or touch the needle cap near the tip of the pre-filled pen. Figure K

10. Position of the pre-filled pen.

10a. Hold the pre-filled pen comfortably with
the needle cap pointing directly against the skin and
position it so that you can see the viewing window.
10b. Without pinching or stretching the skin,
place the pre-filled pen against the skin at a
90-degree angle (see Figure L).
90º
OR
90º
Figure L

11. Administer the injection.

11a. Press down and hold the pre-filled pen firmly against the skin. The 1st click indicates that the injection has started (see Figure M).
11b. Keep the pre-filled pen firmly in place.
1st

• Do not change the injection angle or click remove the pre-filled pen until the injection is complete.

Figure M

12. Monitor the injection by means of

the yellow indicator.
12a. Hold the prefilled pen against the skin.
The yellow indicator will move within the
viewing window (see Figure N).
Figure N

13. Completing the injection.

13a. Wait for the 2nd click. This indicates that the injection is
almost complete (see Figure O).
13b. After hearing the 2nd click, continue to hold the
2
prefilled pen firmly against the skin and
click
count slowly to 5 to ensure the full dose is injected
(see Figure O).
13c. Hold the prefilled pen firmly in place until the yellow indicator
stops moving and completely fills the viewing window, to make sure
Then, count
the injection has been completed.
slowly to 5
Figure O

14. Remove the prefilled pen from the skin and

inspect the yellow indicator (see
Figure P).
14a. After the yellow indicator has stopped moving and has completely filled the viewing window, remove the prefilled pen vertically from the skin. The needle cover will automatically extend and lock over the needle.

• If the yellow indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist.

Figure P

15. Care of the injection site.

15a. If bleeding occurs or a drop of liquid is present at the injection site,
treat the site by gently pressing, without rubbing, a cotton ball or gauze pad against the site, and, if necessary, apply a plaster.

• Do not rub the injection site.

15b. If the medicine comes into contact with the skin, wash the affected area with water.

16. If the prescribed dose requires more than one injection:

16a. Dispose of the prefilled pen as described in step 17 and Figure Q.
16b. Repeat steps 2 to 15 for the next injection using a new prefilled pen.
16c. Choose a different injection site for each new injection, at least 2 cm away
from other injection sites.
16d. Complete all required injections for the prescribed dose, administering them one immediately after
the other. If you have any doubts, consult your healthcare provider.
After the injection

17. Disposal of the pre-filled pen

17a. Dispose of the pre-filled pen and other
materials provided in a sharps disposal container
immediately after use (see Figure Q).

• Do not reuse the pre-filled pen.
• Do not reinsert the cap onto the pre-filled pen.
• Do not dispose of the used sharps disposal
  container into household waste unless permitted
  by local guidelines.
• Do not recycle the used sharps disposal container.

If you do not have a sharps disposal container, you may use a household container that is:

• made of heavy-duty, puncture-resistant plastic;
• securely closed, with a puncture-resistant lid from which sharp objects cannot escape;
• stable in an upright position during use;
• leak-proof; and
• properly labeled with warnings regarding the hazardous waste inside the container.

Consult your doctor or pharmacist for instructions on how to dispose of the sharps disposal container. Local regulations regarding waste disposal may apply.

Package leaflet: information for the user

Omlyclo 150 mg solution for injection in pre-filled syringe, 300 mg solution for injection in pre-filled syringe

omalizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Omlyclo is and what it is used for
2. What you need to know before using Omlyclo
3. How to use Omlyclo
4. Possible side effects
5. How to store Omlyclo
6. Contents of the pack and other information

1. What Omlyclo is and what it is used for

Omlyclo contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
natural proteins produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Omlyclo is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of moderate-to-severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma medications, but in whom asthma symptoms are not well controlled by medications such as high-dose inhaled corticosteroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age) who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid), but in whom symptoms are not well controlled by these medications. Nasal polyps are small growths on the lining of the nose. Omlyclo helps reduce the size of nasal polyps and improves symptoms, including nasal congestion, loss of sense of smell, mucus in the back of the throat, and runny nose.
Chronic spontaneous urticaria (CSU)
This medicine is used for the treatment of chronic spontaneous urticaria in adults and adolescents (from 12 years of age) who are already taking antihistamines, but whose CSU symptoms are not well controlled by these medicines.
Omlyclo works by blocking a substance called immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma, chronic rhinosinusitis with nasal polyps, and CSU.

2. What you need to know before using Omlyclo

Do not use Omlyclo

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6) (see special warnings at the end of this section under “Omlyclo contains polysorbate”).
• if you think you are allergic to any of the ingredients, tell your doctor, as you must not use Omlyclo.

Warnings and precautions
Talk to your doctor before using Omlyclo:

• if you have kidney or liver problems
• if you have a disorder in which your immune system attacks part of your body (autoimmune disease)
• if you plan to travel to areas where parasitic infections are common, because Omlyclo may reduce your resistance to these infections.
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, following a medicine, an insect sting, or food.

Omlyclo does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Omlyclo
must not be used to treat these symptoms.
Do not use Omlyclo to prevent or treat other allergic conditions such as sudden allergic reactions,
hyperimmunoglobulina E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease),
food allergy, eczema, or hay fever, as Omlyclo has not been studied in these conditions.
Be alert for signs of allergic reactions and other serious side effects
Omlyclo may potentially cause serious side effects. You should be alert for signs of these conditions while using Omlyclo. Seek immediate medical help if you notice any sign of a severe allergic reaction or other serious side effects. These signs are listed in section 4 under “Serious side effects”.
Before you self-inject Omlyclo or before someone who is not a healthcare professional administers the injection, it is important that your doctor provides you with instructions on how to recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur (see section 3, “How to use Omlyclo”). Most severe allergic reactions occur within the first 3 doses of Omlyclo.
Children and adolescents
Allergic asthma
Omlyclo is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.
Chronic rhinosinusitis with nasal polyps
Omlyclo is not recommended for children and adolescents under 18 years of age. Use in children and adolescents under 18 years has not been studied.
Chronic spontaneous urticaria (CSU)
Omlyclo is not recommended for children under 12 years of age. Use in children under 12 years has not been studied.
Other medicines and Omlyclo
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is especially important if you are taking:

• medicines to treat a parasitic infection, as Omlyclo may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before using this medicine. Your doctor will discuss with you the benefits and potential risks of using this medicine during pregnancy.
If you become pregnant while being treated with Omlyclo, inform your doctor immediately.
Omlyclo may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.
Driving and using machines
It is unlikely that Omlyclo will affect your ability to drive or operate machinery.
Omlyclo contains polysorbate
Each pre-filled syringe of Omlyclo 150 mg contains 0.40 mg of polysorbate 20 and each pre-filled syringe of Omlyclo 300 mg contains 0.80 mg of polysorbate 20, equivalent to 0.40 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you or the child have known allergies.

3. How to use Omlyclo

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor, nurse, or pharmacist.

How to use Omlyclo
Omlyclo is administered as an injection under the skin (known as a subcutaneous injection).

Omlyclo injection

• Your doctor will decide whether you can self-inject Omlyclo. The first 3 doses must always be administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (e.g. a relative) may also administer the Omlyclo injection after receiving proper training.

For detailed instructions on how to inject Omlyclo, see “Instructions for use of Omlyclo pre-filled syringe” at the end of this leaflet.

Instructions on recognizing severe allergic reactions
It is also important that you do not self-inject Omlyclo until you have been trained by your doctor or nurse on:

• how to recognize early signs and symptoms of a severe allergic reaction;
• what to do if symptoms occur.

For further information on early signs and symptoms of severe allergic reactions, see section 4.

Dosage

Allergic asthma and chronic rhinosinusitis with nasal polyps
Your doctor will determine the dose of Omlyclo you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE level in the blood.
You will need between 1 and 4 injections at a time. You will require injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyp medication during treatment with Omlyclo. Do not stop taking your asthma and/or nasal polyp medications without first consulting your doctor.
You may not notice immediate improvement after starting Omlyclo therapy. In patients with nasal polyps, effects are typically seen after 4 weeks of treatment. In asthmatic patients, full effect is usually achieved after 12–16 weeks.

Chronic spontaneous urticaria (CSU)
Two injections of 150 mg each, or one injection of 300 mg, are required every four weeks.
Continue taking your current CSU medication during treatment with Omlyclo. Do not stop taking any medication without consulting your doctor.

Use in children and adolescents

Allergic asthma
Omlyclo can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled steroids and inhaled beta-agonists. Your doctor will determine the dose of Omlyclo needed and how often it should be administered. This depends on the child’s body weight and the results of a blood test performed before starting treatment to measure the child’s IgE level in the blood.
Self-administration of Omlyclo is not permitted for children (aged 6–11 years). However, if deemed appropriate by the doctor, the Omlyclo injection may be given by a caregiver after proper training.
The Omlyclo 300 mg pre-filled syringe is not intended for use in children under 12 years of age. The Omlyclo 75 mg and Omlyclo 150 mg pre-filled syringes may be used in children aged 6 to 11 years with allergic asthma.

Chronic rhinosinusitis with nasal polyps
Omlyclo must not be used in children and adolescents under 18 years of age.

Chronic spontaneous urticaria (CSU)
Omlyclo can be used in adolescents aged 12 years and older who are already taking antihistamines but whose CSU symptoms are not well controlled by these medications. The dose for adolescents aged 12 years and older is the same as for adults.

If you miss a dose of Omlyclo
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Omlyclo, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should receive your next dose.

If you stop treatment with Omlyclo
Do not stop treatment with Omlyclo unless your doctor tells you to. Stopping or interrupting treatment with Omlyclo may cause your symptoms to return.
However, if you are being treated for CSU, your doctor may temporarily discontinue Omlyclo treatment from time to time to assess your symptoms. Follow your doctor’s instructions.

If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The side effects caused by Omlyclo are usually mild or moderate, but occasionally they can be severe.

Serious side effects:
If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: skin rash, itching or hives, swelling of the face, lips, tongue, larynx (vocal cords), trachea, or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Omlyclo, you may have a higher risk of developing a severe allergic reaction after using Omlyclo.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, skin rash, fever, weight loss, and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or skin rash around blood or lymph vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as bleeding or bruising more easily than usual.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• injection site reactions such as pain, swelling, itching, and redness
• pain in the upper abdomen
• headache (very common in children)
• upper respiratory tract infections such as pharyngitis and common cold
• feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• joint pain (arthralgia)
• dizziness

Uncommon (may affect up to 1 in 100 people)

• feeling drowsy or tired
• tingling or numbness in the hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, skin rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from the available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omlyclo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled syringe may be stored for a total period of 7 days at room temperature (25 °C).
• Store in the original packaging to protect the medicine from light.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Do not use if the packaging is damaged or shows signs of tampering.

6. Contents of the pack and other information

What Omlyclo contains

• The active substance is omalizumab.
• A 1 mL syringe of solution contains 150 mg of omalizumab.
• A 2 mL syringe of solution contains 300 mg of omalizumab.
• The other components are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20 (E 432), and water for injections.

Description of the appearance of Omlyclo and contents of the pack
Omlyclo solution for injection is a solution ranging from clear to slightly opalescent, from colourless to pale yellowish-brown, contained in a pre-filled syringe.
Omlyclo 150 mg solution for injection is available in a pack containing 1 pre-filled syringe and in multiple packs containing 3 (3 x 1), 6 (6 x 1), or 10 (10 x 1) pre-filled syringes.
Omlyclo 300 mg solution for injection is available in a pack containing 1 pre-filled syringe and in multiple packs containing 2 (2 x 1), 3 (3 x 1), or 6 (6 x 1) pre-filled syringes.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest,
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot,
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1 528 7418 Tel.: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Teл.: +36 1 231 0493 Tél/Tel: + 32 1 528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd.
[email protected] Tel: +356 2093 9800
Tlf: +45 3535 2989

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 303 464 941 50 Tel: + 31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Österreich
CELLTRION FARMACEUTICA (ESPAÑA) S.L. Astro-Pharma GmbH
Tel: +34 910 498 478 Tel: +43 1 97 99 860
[email protected]

Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 - 120 Tel.: +36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL LDA
Tél.: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tālr.: +36 1 231 0493

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF OMLYCLO PRE-FILLED SYRINGE

Read and follow the instructions for use that come with the Omlyclo pre-filled syringe before starting to use it and each time you receive a new prescription. There may be new information. Before using the Omlyclo pre-filled syringe for the first time, ensure that your healthcare provider shows you the correct way to use it.

Children (aged 6 to 11 years) must not self-inject the Omlyclo pre-filled syringe alone. However, if considered appropriate by the doctor, the injection may be administered by a caregiver after receiving adequate training.

Parts of the pre-filled syringe (see Figure A)

Before use
After use
Plunger

Grip
Observation
window

Medicine
Needle
Safety
shield
Needle
Cap
Figure A

Select the correct pre-filled syringe or combination of pre-filled syringes
Omlyclo pre-filled syringes are available in 3 strengths (see Figure B). These
instructions apply to all strengths.

75 mg/0.5 mL
Yellow plunger
150 mg/1 mL
Blue plunger
300 mg/2 mL
White plunger
Figure B

Your prescribed dose may require more than one injection. The following dosing table (Figure C) shows the combinations of pre-filled syringes needed to administer the complete dose. Check the label on the Omlyclo carton to ensure you have received the correct pre-filled syringe or combination of pre-filled syringes for your prescribed dose. If your prescribed dose requires more than one injection, administer all injections for the prescribed dose consecutively, one after the other. If you have any doubts, consult your healthcare provider.

Consult your healthcare provider if you have any doubts about the dosage table.
Dosage table
Pre-filled syringes required
Dose
Yellow Blue White
(mg)
(75 mg) (150 mg) (300 mg)

150

225 +
300
(12 years and older)
300

(children under 12 years of age)
375
+
(12 years and older)
375

(children under 12 years of age)
450
+
(12 years and older)
450

(children under 12 years of age)
525

• +
  (12 years and older)
  525

(children under 12 years of age)
600
(12 years and older)

600
(children under 12 years of age)
Figure C
Note: Your healthcare provider may prescribe a different combination of pre-filled syringes for your complete dose.
Important information you should know before using Omlyclo

• Omlyclo is intended for subcutaneous injection only (inject directly into the fatty layer beneath the skin).
• The pre-filled syringe is equipped with a safety shield that automatically activates to cover the needle after injection. The safety shield helps prevent needlestick injuries, protecting anyone handling the pre-filled syringe after use.
• Do not open the sealed carton until you are ready to use the pre-filled syringe.
• Do not use if the carton or the pre-filled syringe is damaged or appears tampered with.
• Do not remove the cap until you are ready to administer the injection.
• Do not use if the pre-filled syringe has fallen on a hard surface or has been dropped after removing the cap.
• Do not reuse the same pre-filled syringe.
• Do not leave the pre-filled syringe unattended.
• Do not attempt to disassemble the pre-filled syringe.
• Do not pull back the plunger.

How to store Omlyclo?

• Store unused pre-filled syringes in their original carton in the refrigerator at 2 °C to 8 °C.
• Do not remove the pre-filled syringe from the original carton during storage.
• Keep the pre-filled syringe in the original carton until ready to use to protect it from light.
• Do not freeze.
• Do not use the pre-filled syringe if it has been frozen.
• Before administering an injection, the carton may be removed from the refrigerator and returned if necessary. The total cumulative time outside the refrigerator must not exceed 7 days. If the pre-filled syringe is exposed to temperatures above 25 °C, do not use it and dispose of it in a sharps disposal container.
• Keep the pre-filled syringe, the sharps disposal container, and all medicines out of sight and reach of children. The pre-filled syringe contains small parts.

Injection preparation

1. Remove the carton containing the pre-filled syringe

from the refrigerator and allow the
pre-filled syringe to reach room temperature.
a. If more than 1 pre-filled syringe is required
to administer the prescribed dose,
remove all necessary cartons from the
refrigerator simultaneously 30–45 minutes
before use (each carton contains 1 pre-filled
syringe) (see Figure C). The following
procedure must be followed for each
pre-filled syringe.
b. Set the closed carton aside on a clean,
flat surface for at least 30–45 minutes to
allow the pre-filled syringe to warm up.
Keep the pre-filled syringe inside the
carton to protect it from light (see Figure D).
Figure D Do not warm the pre-filled syringe
using other heat sources such as warm
water or a microwave.
If the pre-filled syringe does not reach
room temperature, the injection may be
uncomfortable and pushing the plunger
may be difficult.

2. Gather the injection supplies

(see Figure E).
Kit containing the pre-filled
syringe
Not included in the kit:

• Alcohol swab

• Cotton ball or gauze pad

• Adhesive bandage

• Sharps disposal container

Note: More than 1 pre-filled syringe may be
required for the prescribed dose. For
further information, see the following
dosage table (see Figure C).
Each kit contains 1 pre-filled syringe.
Figure E

3. Check the expiration date shown

on the carton (see Figure F).
Do not use if the expiration date has
been exceeded.
If the expiration date has been exceeded,
dispose of the carton safely in a
sharps disposal container (see step 16.
Dispose of the pre-filled syringe ) and
contact your healthcare provider.
Figure F

4. Wash your hands.

a. Wash your hands with soap and water and
dry them thoroughly (see Figure G).
Figure G

5. Remove the pre-filled syringe

from the carton.
a. Open the carton.
b. Grasp the body of the syringe and remove
the pre-filled syringe from the carton
(see Figure H).
Do not touch the plunger or the cap
when removing the pre-filled syringe
from the carton.
Figure H

6. Inspect the prefilled syringe.

a. Check the prefilled syringe and
ensure it contains the correct medicine

(Omlyclo) and correct dosage.
b. Inspect the prefilled syringe to
ensure it is not broken or damaged.
Do not use if the prefilled syringe is
damaged or appears tampered with.
c. Check the expiration date shown
on the label of the prefilled syringe
(see Figure I).
Do not use if the expiration date has
been exceeded.
Note: If the expiration date is not visible in the
observation window, rotate the inner cylinder of the
prefilled syringe until the expiration date becomes
Figure I
visible.

7. Inspect the medicine.

a. Examine the medicine to make sure the
liquid is from clear to slightly
opalescent, from colorless to pale yellow-brown,
and free of particles (see Figure J).
Do not use the pre-filled syringe if the
liquid has changed color, is distinctly
cloudy, or contains particles.
It is normal to see air bubbles in the
liquid.
Do not attempt to remove the air
bubbles.
b. If the medicine does not match the
description provided or if the expiration
date has passed, safely dispose of the
Figure J
pre-filled syringe in a sharps disposal
container (see step 16) and contact
your healthcare provider.

8. Choose an injection site (see

Figure K).
a. If self-administered, the injection may be given:

• on the front of the thighs;
• in the lower abdomen, except for
  the area within 5 cm around
  the navel.
  b. If administered by an assisting person or healthcare professional, the injection may be given:
• on the outer area of the upper arms;
• on the front of the thighs;
• in the lower abdomen, except for
  the area within 5 cm around
  the navel.
  Do not inject into moles,
  scars, bruises, or in areas where the
  skin is tender, red, hardened, or not intact.
  Do not administer the injection through
  clothing. The injection site must be
  Figure K an exposed and clean area of skin.
  If the prescribed dose requires more than
  1 injection, administer the injections at sites
  at least 2 cm apart from each other.

9. Clean the injection site.

a. Clean the injection site with an alcohol swab using circular motions (see Figure L).
b. Allow the skin to dry for 10 seconds before administering the injection.
Do not wave air over or blow on the cleaned area.
Do not touch the injection site again before giving the injection.
Figure L
Administering the injection

10. Remove the cap.

a. Hold the pre-filled syringe barrel with one hand.
b. With the other hand, gently pull off the cap in a straight line (see Figure M).
Do not remove the cap until ready to administer the injection.
Do not twist the cap.
Do not hold, push, or pull the plunger while removing the cap.
You may notice a few drops of liquid at the needle tip. This is normal.
c. Immediately dispose of the cap into a sharps disposal container (see step 16. Disposal of the pre-filled syringe and Figure M).
Do not re-cap the pre-filled syringe.
Once the cap has been removed, do not touch the needle and avoid contact with any surface.

11. Insert the pre-filled syringe at the

injection site.
a. With one hand, gently pinch a fold of skin at the injection site. Hold the skin fold firmly until the injection is complete.
Note: This step is important to ensure that the injection is delivered under the skin (into the fatty tissue) and not deeper (into the muscle).

b. Insert the needle completely into the skin fold at an angle of approximately 45 degrees with a quick, firm motion (see Figure N).
Note: It is important to maintain the correct angle to ensure that the medicine is administered under the skin (into the fatty tissue); otherwise, the injection may be painful and the medicine may not work properly.
Figure N
Do not touch the plunger while inserting the needle into the skin.
Do not insert the needle through clothing.
Once the needle is inserted, hold the pre-filled syringe firmly in place and do not change the injection angle or reinsert the needle. The patient should remain still and avoid sudden movements during the injection.

12. Administer the injection.

a. Slowly push the plunger all the way

to the end of its travel, until the full dose of
medicinal product has been administered
and the pre-filled syringe is empty (see
Figure O).
Do not change the position of the
pre-filled syringe after starting the
injection.
If the plunger is not fully pressed, the
safety protection will not extend to cover
the needle when it is withdrawn.
Figure O

13. Remove the prefilled syringe from the injection site.

of injection.
a. When the prefilled syringe is empty,
slowly lift your thumb off the
plunger until the needle is
completely covered by the safety
shield (see Figure P).
If the needle does not cover, carefully
remove the prefilled syringe from the
skin and dispose of it in a sharps
disposal container (see step 16. Dispose of the prefilled syringe).
b. Remove the prefilled syringe from the
injection site and release the skin fold.
Mild Figure P bleeding may occur (see step 14.
Caring for the injection site).
Do not reuse the prefilled syringe.

14. Care of the injection site.

a. If bleeding occurs or a drop of liquid is present at the injection site,
treat the injection site by gently pressing, without rubbing, a cotton ball or
gauze pad against the site, and, if necessary, apply a plaster.
Do not rub the injection site.
b. If the medicine comes into contact with the skin, wash the area that has been in
contact with the medicine with water.

15. If the prescribed dose requires more than 1 injection:

a. Dispose of the used prefilled syringe as described in step 16. Disposal of the prefilled syringe.
b. Repeat steps 1 to 14 for the next injection, using a new prefilled syringe.
Administer the injections at sites at least 2 cm apart from each other.
Perform all injections for the prescribed dose consecutively, one after the other.
If you have any doubts, consult your healthcare professional.
After the injection

16. Disposal of the pre-filled syringe.

a. Place the used pre-filled syringe into a
sharps disposal container immediately after use
(see Figure Q).

The Omlyclo pre-filled syringe is
single-use and must not be reused.
Do not attempt to re-cap the
needle cover onto the pre-filled syringe.
Do not dispose of (throw away) the
pre-filled syringe in household waste.
If you do not have a sharps disposal container,
you may use a household container that can be
closed and is puncture-resistant.
Figure Q
Ask your doctor or pharmacist for
information on the proper disposal of the
sharps disposal container. Disposal may be
subject to local regulations.

Package leaflet: Information for the user

Omlyclo 150 mg solution for injection in pre-filled pen

omalizumab
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Omlyclo is and what it is used for
2. What you need to know before using Omlyclo
3. How to use Omlyclo
4. Possible side effects
5. How to store Omlyclo
6. Contents of the pack and other information

1. What Omlyclo is and what it is used for

Omlyclo contains the active substance omalizumab. Omalizumab is a synthetic protein similar to
proteins naturally produced by the body. It belongs to a class of medicines called monoclonal
antibodies.
Omlyclo is used to treat:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and nasal sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma
This medicine is used to prevent worsening of asthma by controlling symptoms of severe allergic
asthma in adults, adolescents, and children (from 6 years of age onwards) who are already receiving
asthma medications, but in whom asthma symptoms are not well controlled by medications such as
high-dose inhaled steroids and inhaled beta-agonists.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age
onwards) who are already receiving intranasal corticosteroids (nasal spray containing corticosteroid),
but in whom symptoms are not well controlled by these medicines. Nasal polyps are small growths on
the nasal mucosa. Omlyclo helps reduce the size of the polyps and improves symptoms, including nasal
congestion, loss of smell, mucus in the back of the throat, and runny nose.
Chronic spontaneous urticaria (CSU)
This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (from 12 years
of age onwards) who are already taking antihistamines, but in whom CSU symptoms are not well
controlled by these medicines.
Omlyclo works by blocking a substance called immunoglobulin E (IgE), which is produced by the
body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma,
chronic rhinosinusitis with nasal polyps, and CSU.

2. What you need to know before using Omlyclo

Do not use Omlyclo

• if you are allergic to omalizumab or to any of the other ingredients of this medicine (listed in section 6). (See special warnings at the end of this section under “Omlyclo contains polysorbate”) If you think you may be allergic to any of the ingredients, inform your doctor as you must not use Omlyclo.

Warnings and precautions
Talk to your doctor before using Omlyclo:

• if you have kidney or liver problems
• if you have a condition in which your immune system attacks part of your body (autoimmune disease)
• if you plan to travel to areas where infections caused by parasites are common, because Omlyclo may reduce your resistance to these infections.
• if you have previously experienced a severe allergic reaction (anaphylaxis), for example, due to a medicine, insect sting, or food.

Omlyclo does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Omlyclo
must not be used to treat these symptoms.
Do not use Omlyclo to prevent or treat other allergic conditions such as sudden allergic reactions,
hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungal lung disease),
food allergy, eczema, or hay fever, as Omlyclo has not been studied in these conditions.
Be alert to signs of allergic reactions and other serious adverse effects
Omlyclo may potentially cause serious adverse effects. You should be aware of the signs of these
conditions while using Omlyclo. Seek immediate medical help if you notice any signs of a severe
allergic reaction or other serious adverse effects. These signs are listed in section 4 under “Serious
adverse effects”.
Before you self-inject Omlyclo or before the injection is administered by someone who is not a
healthcare professional, it is important that your doctor provides you with instructions on how to
recognize early symptoms of severe allergic reactions and how to manage these reactions if they occur
(see section 3, “How to use Omlyclo”). Most severe allergic reactions occur within the first 3 doses of
Omlyclo.
Children and adolescents
Allergic asthma
Omlyclo is not recommended in children under 6 years of age. Use in children under 6 years has not
been studied.
Chronic rhinosinusitis with nasal polyps
Omlyclo is not recommended in children and adolescents under 18 years of age. Use in children and
adolescents under 18 years has not been studied.
Chronic spontaneous urticaria (CSU)
Omlyclo is not recommended in children under 12 years of age. Use in children under 12 years has not
been studied.
Other medicines and Omlyclo
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other
medicines.
This is especially important if you are taking:

• medicines for the treatment of a parasitic infection, as Omlyclo may reduce the effectiveness of these medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your
doctor before using this medicine. Your doctor will discuss with you the benefits and potential risks of
using this medicine during pregnancy.
If you become pregnant while being treated with Omlyclo, inform your doctor immediately.
Omlyclo may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your
doctor before using this medicine.
Driving and using machines
It is unlikely that Omlyclo will affect your ability to drive or operate machinery.
Omlyclo contains polysorbate
This medicine contains 0.40 mg of polysorbate 20 per pre-filled pen, equivalent to 0.40 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you or your child have known allergies.

3. How to use Omlyclo

Use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor, nurse, or pharmacist.

How Omlyclo is used
Omlyclo is administered as an injection under the skin (known as a subcutaneous injection).

• You and your doctor will decide whether you can self-inject Omlyclo. The first 3 doses are always administered by a healthcare professional or under their supervision (see section 2).
• It is important that you are properly trained in how to inject the medicine before giving yourself an injection.
• A person assisting you (e.g. a family member) may also administer the Omlyclo injection after receiving appropriate training.

For detailed instructions on how to inject Omlyclo, see "Instructions for using the Omlyclo pre-filled pen" at the end of this leaflet.

Instructions on recognizing severe allergic reactions
It is also important that you do not self-inject Omlyclo until you have been trained by your doctor or nurse on:

• how to recognize the early signs and symptoms of a severe allergic reaction;
• what to do if symptoms occur. For further information on the early signs and symptoms of severe allergic reactions, see section 4.

Dosage
Allergic asthma and chronic rhinosinusitis with nasal polyps
Your doctor will determine the dose of Omlyclo you need and how often you should use it. This depends on your body weight and the results of a blood test performed before starting treatment to measure your IgE levels.
You will need between 1 and 4 injections at a time. You will require injections every two weeks or every four weeks.
Continue taking your current asthma and/or nasal polyps medication during treatment with Omlyclo. Do not stop taking your asthma and/or nasal polyps medication without first consulting your doctor.
You may not notice immediate improvement after starting Omlyclo treatment. In patients with nasal polyps, effects become apparent after 4 weeks of treatment. In asthmatic patients, full effect is usually achieved after 12–16 weeks.

Chronic spontaneous urticaria (CSU)
Two injections of 150 mg each are required every four weeks.
Continue taking your current medication for CSU during treatment with Omlyclo. Do not stop taking any medication without consulting your doctor.

Use in children and adolescents
Allergic asthma
Omlyclo can be used in children and adolescents aged 6 years and older who are already taking asthma medications but whose asthma symptoms are not well controlled by high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will determine the amount of Omlyclo the child needs and how often it should be administered. This will depend on the child's body weight and the results of a blood test performed before starting treatment to measure the child's IgE levels.
Self-administration of Omlyclo is not permitted for children (aged 6 to 11 years). However, if the doctor considers it appropriate, the Omlyclo injection may be administered by a caregiver after proper training.
Omlyclo pre-filled pens are not intended for use in children under 12 years of age. The Omlyclo 75 mg pre-filled syringe and the Omlyclo 150 mg pre-filled syringe may be used in children aged 6 to 11 years with allergic asthma.

Chronic rhinosinusitis with nasal polyps
Omlyclo must not be used in children and adolescents under 18 years of age.

Chronic spontaneous urticaria (CSU)
Omlyclo can be used in adolescents aged 12 years and older who are already taking antihistamines but whose CSU symptoms are not well controlled by these medications. The dose for adolescents aged 12 years and older is the same as for adults.

If you miss a dose of Omlyclo
If you miss an appointment, contact your doctor or hospital as soon as possible to schedule a new one.
If you forget to administer a dose of Omlyclo, inject the missed dose as soon as you remember. Then contact your doctor to determine when you should administer the next dose.

If you stop treatment with Omlyclo
Do not stop treatment with Omlyclo unless your doctor tells you to. Stopping or discontinuing treatment with Omlyclo may cause symptoms to return.
However, if you are being treated for CSU, your doctor may periodically discontinue Omlyclo treatment to assess your symptoms. Follow your doctor's instructions.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Omlyclo are usually mild or moderate, but occasionally they can be serious.

Serious side effects:

If you notice any of the symptoms listed below, seek immediate medical help:

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reactions (including anaphylaxis). Symptoms may include: rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (vocal cords), trachea or other parts of the body, rapid heartbeat, dizziness and vertigo, confusion, shortness of breath, wheezing or difficulty breathing, blue skin or lips, fainting or loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Omlyclo, you may have an increased risk of developing a severe allergic reaction following use of Omlyclo.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, skin rash, fever, weight loss and fatigue.

Not known (frequency cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. One or more of the following symptoms may occur: swelling, pain or skin rash around blood or lymph vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening breathing problems, nasal congestion, heart problems, pain, numbness, or tingling in arms or legs.
• Reduced platelet count in the blood, with symptoms such as unusual bleeding or bruising.
• Serum sickness. One or more of the following symptoms may occur: joint pain with or without swelling or stiffness, skin rashes, fever, swollen lymph nodes, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• fever (in children)

Common (may affect up to 1 in 10 people)

• injection site reactions such as pain, swelling, itching, and redness
• upper abdominal pain
• headache (very common in children)
• upper respiratory tract infections such as pharyngitis and common cold
• feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• joint pain (arthralgia)
• dizziness

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness in the hands or feet
• fainting, low blood pressure when sitting or standing (postural hypotension), flushing
• sore throat, cough, acute breathing problems
• feeling unwell (nausea), diarrhoea, indigestion
• itching, hives, rash, increased sensitivity of the skin to sunlight
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Not known (frequency cannot be estimated from the available data)

• muscle pain and joint swelling
• hair loss

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Omlyclo

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month. Before use, the carton containing the pre-filled pen can be stored for a total period of 7 days at room temperature (25 °C).
• Store in the original packaging to protect the medicine from light.
• Store in a refrigerator (2 °C - 8 °C). Do not freeze.
• Do not use if the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What Omlyclo contains

• The active substance is omalizumab. One pre-filled pen containing 1 mL of solution contains 150 mg of omalizumab.
• The other components are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20 (E 432) and water for injections.

Description of the appearance of Omlyclo and contents of the pack
Omlyclo solution for injection is a solution ranging from clear to slightly opalescent, colourless to pale yellowish-brown, contained in a pre-filled pen.
Omlyclo 150 mg solution for injection is available in a pack containing 1 pre-filled pen and in multiple packs containing 2 (2 x 1), 3 (3 x 1), 6 (6 x 1) or 10 (10 x 1) pre-filled pens.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Celltrion Healthcare Hungary Kft.
1062 Budapest,
Váci út 1-3. WestEnd Office Building B tower
Hungary

Manufacturer
Nuvisan France SARL
2400, Route des Colles
06410, Biot,
France
MIDAS Pharma GmbH
Rheinstrasse 49
55218 West Ingelheim Am Rhein
Rhineland-Palatinate
Germany
Kymos S.L.
Ronda de Can Fatjó 7B
Parc Tecnològic del Vallès
08290 Cerdanyola Del Valles
Barcelona
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Celltrion Healthcare Belgium BVBA Celltrion Healthcare Hungary Kft.
Tél/Tel: + 32 1 528 7418 Tel.: +36 1 231 0493
[email protected]

България Luxembourg/Luxemburg
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Belgium BVBA
Teл.: +36 1 231 0493 Tél/Tel: + 32 1 528 7418
[email protected]

Česká republika Magyarország
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Tel: +36 1 231 0493 Tel.: +36 1 231 0493

Danmark Malta
Celltrion Healthcare Denmark ApS Mint Health Ltd.
[email protected] Tel: +356 2093 9800
Tlf: +45 3535 2989

Deutschland Nederland
Celltrion Healthcare Deutschland GmbH Celltrion Healthcare Netherlands B.V.
Tel: +49 303 464 941 50 Tel: + 31 20 888 7300
[email protected] [email protected]

Eesti Norge
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Norway AS
Tel: +36 1 231 0493 [email protected]
[email protected]

España Ö sterreich
CELLTRION FARMACEUTICA (ESPAÑ A) S.L. Astro-Pharma GmbH
Tel: +34 910 498 478 Tel: +43 1 97 99 860
[email protected]

Ελλάδα Polska
ΒΙΑΝΕΞ Α.Ε. Celltrion Healthcare Hungary Kft.
Τηλ: +30 210 8009111 - 120 Tel.: +36 1 231 0493

France Portugal
Celltrion Healthcare France SAS CELLTRION PORTUGAL, UNIPESSOAL LDA
Tél.: +33 (0)1 71 25 27 00 Tel: +351 21 936 8542
[email protected]

Hrvatska România
Oktal Pharma d.o.o. Celltrion Healthcare Hungary Kft.
Tel: +385 1 6595 777 Tel: +36 1 231 0493

Ireland Slovenija
Celltrion Healthcare Ireland Limited OPH Oktal Pharma d.o.o.
Tel: +353 1 223 4026 Tel.: +386 1 519 29 22
[email protected]

Ísland Slovenská republika
Celltrion Healthcare Hungary Kft. Celltrion Healthcare Hungary Kft.
Sími: +36 1 231 0493 Tel: +36 1 231 0493
[email protected]

Italia Suomi/Finland
Celltrion Healthcare Italy S.R.L. Celltrion Healthcare Finland Oy.
Tel: +39 0247927040 Puh/Tel: +358 29 170 7755
[email protected] [email protected]

Κύπρος Sverige
C.A. Papaellinas Ltd Celltrion Sweden AB
Τηλ: +357 22741741 Tel: +46 8 80 11 77
[email protected]

Latvija
Celltrion Healthcare Hungary Kft.
Tālr.: +36 1 231 0493

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

INSTRUCTIONS FOR USE OF OMLYCLO PREFILLED PEN

Read and follow the instructions for use that accompany the Omlyclo prefilled pen before starting to
use it and each time you receive a new prescription. There may be new information.
Before using Omlyclo, make sure a healthcare professional has shown you the correct way to use it.
Adolescents aged 12 years and older: self-injection with the Omlyclo prefilled pen may be performed
under the supervision of an adult. The Omlyclo prefilled pen (all doses) is intended for use in adults and
adolescents aged 12 years and older.
Parts of the prefilled pen (see Figure A)

Before use After use
Expiry
date
Body

Blue indicator
Observation
window
“Injection
complete”
Red cap
Cap
(needle covered
red
internally)
Blue cap Blue cap
Figure A
Select the correct prefilled pen or combination of prefilled pens
Omlyclo prefilled pens are available in 2 doses (see Figure B). These instructions should be used for
both doses.

This dose:
Other dose:
150 mg/1 mL 75 mg/0.5 mL
(blue cap) (yellow cap)
Figure B
The dose prescribed to you may require more than one injection. The following dosing table ( Figure C )
shows the combinations of prefilled pens needed to administer the complete dose. Check the label on
the Omlyclo carton to ensure you have received the correct prefilled pen or combination of prefilled
pens for your prescribed dose. If your prescribed dose requires more than one injection, perform all
injections for the prescribed dose consecutively, one after the other. If in doubt, consult your healthcare professional.
Dosing table

Prefilled pens required
Dose
(mg)

Yellow (75 mg/0.5 mL) Blue (150 mg/1 mL)
Figure C
Note: your healthcare professional may prescribe a different combination of prefilled pens for your
complete dose.
How to store Omlyclo

• Store the prefilled pen in its original carton in the refrigerator at 2 °C to 8 °C.
• Before administering an injection, the carton may be removed from the refrigerator and returned if necessary. The total cumulative time outside the refrigerator must not exceed 7 days. If Omlyclo is exposed to temperatures above 25 °C, do not use Omlyclo and dispose of it in a sharps disposal container.
• Do not remove the prefilled pen from its original carton during storage.
• Keep the prefilled pen away from direct sunlight.
• Do not freeze. Do not use the prefilled pen if it has been frozen.
• Keep the prefilled pen, the sharps disposal container, and all medicines out of the sight and reach of children.

Important information

• Do not use if the carton is damaged or appears tampered with.
• Do not open the carton until you are ready to administer the injection.
• Do not use the prefilled pen if it is damaged or appears tampered with.
• Do not remove the cap from the prefilled pen until the time of administering the Omlyclo injection.
• Do not use if the prefilled pen has been dropped on a hard surface or dropped after removing the cap.
• Never attempt to disassemble the prefilled pen.
• Do not clean or touch the needle cap.

Preparing for injection

1. Remove the carton containing the pre-filled pen from the refrigerator.

1a. If more than 1 pre-filled pen is required to administer the prescribed dose (see Figure C), remove all necessary cartons from the refrigerator (each carton contains 1 pre-filled pen). The following procedure must be followed for each pre-filled pen.

2. Gather the injection materials

(see Figure D).
Kit
containing 2a. Kit containing the Omlyclo prefilled
the autoinjector pen
Alcohol swab Not included in the kit:
soaked in

• alcohol swab
• cotton ball or gauze
• adhesive bandage

Cotton
ball or gauze • sharps disposal container
or gauze
Adhesive
bandage Note: More than 1 Omlyclo prefilled pen may be
required for the prescribed dose.
For further information, see the following
Sharps
dosage table ( Figure C ). Each Omlyclo
disposal
kit contains 1 prefilled pen.
container
for used
sharps
Figure D

3. Check the expiration date shown

on the carton (see Figure E).

• Do not use the pre-filled pen if the expiration date has passed.
• If the expiration date has passed, dispose of the pre-filled pen in a
  sharps disposal container (see step 17) and contact
  your healthcare provider.
  Figure E

4. Allow the prefilled pen to

reach room temperature.
4a. Place the carton aside on a flat, clean surface for
30-45 minutes to allow the prefilled pen to warm up to
minuti room temperature, without using any additional
heat sources. Leave the prefilled pen in the carton
to protect it from light (see Figure F).

• If the prefilled pen does not reach room temperature, the injection may be uncomfortable.
• Do not heat the prefilled pen using other heat sources such as warm water or a microwave.

Figure F

5. Open the carton.

5a. Wash hands with soap and water.
5b. Remove the prefilled pen from the carton
by holding it in the middle section (see Figure G).

• Do not turn the carton upside down to remove the prefilled pen, as it may become damaged.
• Do not hold the prefilled pen by the cap.
• Do not remove the cap until ready to administer the injection.

Figure G

6. Inspect the prefilled pen

6a. Examine the viewing window of the prefilled pen to ensure the liquid is from clear to slightly cloudy, colorless to pale yellow-brown, and free of particles. Air bubbles may be visible in the liquid. This is normal (see Figure H).

• Do not use the prefilled pen if the liquid has changed color, is distinctly cloudy, or contains particles.

6b. Check the expiration date of the prefilled pen.

• Do not use the prefilled pen if the expiration date has passed.

6c. Make sure the prefilled pen shows no signs of damage or appears to have been tampered with.

• Do not use the prefilled pen if it is damaged or appears to have been tampered with.

6d. If the medicine does not look as described or if the expiration date has passed, dispose of the prefilled pen safely in a sharps disposal container (see Step 17) and contact your healthcare provider.
Figure H

7. Choose an appropriate injection site

(see Figure I).
7a. The following injection sites are recommended:
o the front of the thighs. The lower abdomen may also be used, but not
the area within 5 cm around the navel;
o the outer area of the arms (only if
the injection is administered by a caregiver or
healthcare professional).

• Do not self-administer the injection in the arm.
• Do not administer the injection into moles, scars, bruises, or areas where the skin is painful, red, hardened, or not intact.

• Do not inject through clothing. The injection site must be an exposed and clean area of skin.
• If the prescribed dose requires more than 1 injection, administer the injections at sites at least 2 cm apart from each other. Figure I

8. Clean the injection site.

8a. Clean the injection site with an alcohol wipe using circular motions,
and let it air dry for 10 seconds (see Figure J).

• Do not touch the injection site again before giving the injection.
• Do not fan or blow on the cleaned area.

Figure J
Administering the injection

9. Remove the cap.

9a. Firmly hold the pre-filled pen with one hand and remove the cap with the other hand (see Figure K).

• Do not rotate the cap.
• Do not reinsert the cap onto the pre-filled pen.

Needle cap of the pre-filled pen.

• You may notice a few drops of liquid at the needle tip. This is normal.

9b. Dispose of the cap in household waste.

• Do not clean or touch the needle cap near the tip of the pre-filled pen.

Figure K

10. Position of the pre-filled pen.

10a. Hold the pre-filled pen comfortably with
the needle cap pointing directly against the skin and
position it so that you can see the viewing window.
10b. Without pinching or stretching the skin,
place the pre-filled pen against the skin at a
90-degree angle (see Figure L).
OR
Figure L

11. Administer the injection.

11a. Press down and hold the pre-filled pen firmly against the skin. The first click indicates that the injection has started (see Figure M).
11b. Keep the pre-filled pen firmly in place.

• Do not change the injection angle or remove the pre-filled pen until the click indicates that the injection is complete.

Figure M

12. Monitor the injection by means of

the blue indicator.
12a. Hold the pre-filled pen against the skin.
The blue indicator will move within the viewing window
(see Figure N).
Figure N

13. Completing the injection.

13a. Wait for the 2nd click. This indicates that the injection is
almost complete (see Figure O).
13b. After hearing the 2nd click, continue to hold the
2 pre-filled pen firmly against the skin and
click count slowly to 5 to ensure the full dose is delivered
(see Figure O).
13c. Keep the pre-filled pen firmly in place until the blue indicator
stops moving and completely fills the viewing window, to ensure
Then, count
the injection has been completed.
slowly to 5
Figure O

14. Remove the pre-filled pen from the skin and

inspect the blue indicator (see
Figure P).
14a. After the blue indicator has stopped moving
and has completely filled the viewing window, remove
the pre-filled pen vertically from the skin. The needle shield will automatically come out
and lock over the needle.

• If the blue indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist.

Figure P

15. Care of the injection site.

15a. If bleeding occurs or a drop of liquid is present at the injection site,
treat the injection site by gently pressing, without rubbing, a cotton ball or gauze pad against the site and, if necessary, apply a plaster.

• Do not rub the injection site.

15b. If the medicine comes into contact with the skin, wash the affected area with water.

16. If the prescribed dose requires more than 1 injection:

16a. Dispose of the prefilled pen as described in step 17 and Figure Q.
16b. Repeat steps 2 to 15 for the next injection using a new prefilled pen.
16c. Choose a different injection site for each new injection, at least 2 cm away
from other injection sites.
16d. Complete all required injections for the prescribed dose, administering them one immediately
after the other. If you have any doubts, contact your healthcare provider.
After the injection

17. Disposal of the pre-filled pen

17a. Dispose of the pre-filled pen and other
supplied materials into a sharps disposal container
immediately after use (see Figure Q).

• Do not reuse the pre-filled pen.

• Do not reinsert the cap onto the pre-filled pen.

• Do not dispose of the used sharps disposal
  container into household waste unless local
  guidelines permit it.

• Do not recycle the used sharps disposal container.

If a sharps disposal container is not available, a household container may be used provided it is:

• made of hard, puncture-resistant plastic;
• securely closed, with a puncture-resistant lid from which sharps cannot escape;
• stable when standing upright during use;
• leak-resistant; and
• appropriately labeled with warnings indicating hazardous waste inside the container.

Consult your doctor or pharmacist for instructions on how to dispose of the sharps disposal container. Local regulations regarding waste disposal may apply.

Figure Q