Omylclo 150 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Omlyclo 150 mg solution for injection in pre-filled syringe

omalizumab

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. 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 human protein, similar to naturally occurring proteins produced by the body. It belongs to a class of medicines known as monoclonal antibodies.

Omlyclo is used to treat:

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

Allergic asthma

This medicine is used to prevent asthma from worsening by controlling symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already receiving asthma medications, but whose symptoms are not adequately controlled with 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 receiving intranasal corticosteroids (nasal spray with corticosteroids), but whose symptoms are not well controlled with these medications. Nasal polyps are small growths in the lining of the nose. Omlyclo helps reduce the size of the polyps and improves symptoms including nasal congestion, loss of sense of smell, postnasal drip, and nasal discharge.

Chronic spontaneous urticaria (CSU)

This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (from 12 years of age) who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medications.

Omlyclo works by blocking a substance called immunoglobulin E (IgE) that is produced by the body. IgE is involved in 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 the special warnings at the end of this section, under the subtitle “Omlyclo contains polysorbate”).

If you think you may be allergic to any of the components, 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 parts of your own body (autoimmune disease),
• if you are travelling to an area where parasitic infections are common, as Omlyclo may reduce your resistance to such 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 should not be used to treat these types of symptoms.

Omlyclo is not intended to prevent or treat other allergic-type conditions such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a lung disease caused by a fungus), food allergy, eczema, or hay fever, as Omlyclo has not been studied in these conditions.

Monitor for signs of allergic reactions and other serious adverse effects

Omlyclo may cause serious adverse effects. You should monitor for signs of these effects while using Omlyclo. Seek immediate medical help if you notice any signs indicating a serious allergic reaction or other serious adverse effects. These signs are described in “Serious adverse effects” in section 4.

Before you or someone other than a healthcare professional administers an Omlyclo injection, it is important that you receive training from your doctor on how to recognize early symptoms of serious allergic reactions and what to do if they occur (see section 3, “How to use Omlyclo”). Most serious allergic reactions occur during the first three doses of Omlyclo.

Children and adolescents

Allergic asthma

Omlyclo is not recommended for children under 6 years of age. Its use has not been studied in children under 6 years of age.

Chronic rhinosinusitis with nasal polyps

Omlyclo is not recommended for children and adolescents under 18 years of age. Its use has not been studied in patients under 18 years of age.

Chronic spontaneous urticaria (CSU)

Omlyclo is not recommended for children under 12 years of age. Its use has not been studied in children under 12 years of age.

Other medicines and Omlyclo

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

This is especially important if you are using:

• 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, talk to your doctor before using this medicine. Your doctor will discuss with you the potential benefits and risks of using this medicine during pregnancy.

Inform your doctor immediately if you become pregnant while being treated with Omlyclo.

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 polysorbates

This medicine contains 0.40 mg of polysorbate 20 in each 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

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

How Omlyclo is used

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

Omlyclo injection

• You and your doctor will decide whether you will self-inject Omlyclo. The first three doses will always be administered under the supervision of a healthcare professional (see section 2).
• It is important that you receive proper training on how to inject the medicine before self-administering it.
• A caregiver (for example, parents) may administer the Omlyclo injection after receiving appropriate training.

For detailed instructions on how to inject Omlyclo, see "Instructions for use of Omlyclo in prefilled syringe" at the end of this leaflet.

Training for recognizing severe allergic reactions

It is also important that you do not self-inject Omlyclo until your doctor or nurse has taught you:

• how to recognize early signs and symptoms of severe allergic reactions,
• what to do if symptoms occur.

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

How much to administer

Allergic asthma and chronic rhinosinusitis with nasal polyps

Your doctor will determine the dose of Omlyclo you need and how often it should be administered. This depends on your body weight and the results of a blood test performed before starting treatment to determine the concentration of IgE in your blood.

You will need between 1 and 4 injections at the same time. You will need the injections every two or every four weeks.

Continue taking your current asthma and/or nasal polyps medication during treatment with Omlyclo. Do not stop any asthma and/or nasal polyps medication without consulting your doctor.

You may not experience immediate improvement after starting treatment with Omlyclo. In patients with nasal polyps, effects have been observed 4 weeks after starting treatment. In patients with asthma, it generally takes between 12 and 16 weeks for the medicine to achieve its full effect.

Chronic spontaneous urticaria (CSU)

You will need two 150 mg injections at the same time every four weeks.

Continue taking your current medication for CSU during treatment with Omlyclo. Do not stop 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 receiving asthma medication but whose asthma symptoms are not well controlled by medications such as high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will inform you of the dose of Omlyclo your child needs and how often it should be administered. This will depend on the child's body weight and the results of blood tests performed before starting treatment to determine the level of IgE in their blood.

Children (aged 6 to 11 years) should not self-administer Omlyclo. However, if the doctor considers it appropriate, a caregiver may administer the Omlyclo injection after receiving adequate training.

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 receiving 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 forget a dose of Omlyclo

If you miss an appointment, contact your doctor or hospital as soon as possible to reschedule.

If you forget to self-inject a dose of Omlyclo, inject it as soon as you remember. Then consult your doctor to determine when the next dose should be administered.

If you stop treatment with Omlyclo

Do not stop treatment with Omlyclo unless instructed by your doctor. Stopping or discontinuing treatment with Omlyclo may cause a recurrence of your symptoms.

However, if you are being treated for CSU, your doctor may occasionally interrupt treatment with Omlyclo to assess your symptoms. Follow your doctor's instructions.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The adverse effects caused by Omlyclo are generally mild to moderate, but may occasionally be severe.

Serious adverse effects:

Seek immediate medical attention if you notice any of the following signs of serious adverse effects:

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

• Severe allergic reactions (including anaphylaxis). Symptoms may include rash, itching, hives, swelling of the face, lips, tongue, larynx (voice box), trachea or other parts of the body, rapid heartbeat, dizziness and lightheadedness, confusion, dyspnea, wheezing or difficulty breathing, blue-colored skin or lips, collapse and 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 after using Omlyclo.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Frequency not known (cannot be estimated from available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. Symptoms may include one or more of the following: swelling, pain or rash around blood or lymph vessels, elevated levels of a specific type of white blood cells (marked eosinophilia), worsening respiratory problems, nasal congestion, heart problems, pain, numbness, or tingling in arms and legs.
• Low platelet count, with symptoms such as bleeding or bruising occurring more easily than normal.
• Serum sickness. Symptoms may include one or more of the following: joint pain with or without inflammation or stiffness, rash, fever, swollen lymph nodes, muscle pain.

Other adverse effects include:

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

• fever (in children)

Common (may affect up to 1 in 10 patients)

• injection site reactions including 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 patients)

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

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

• parasitic infection

Frequency not known (cannot be estimated from available data)

• muscle pain and joint inflammation
• hair loss

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 CAD/EXP. The expiry date refers to the last day of the month indicated. The packaging containing the pre-filled syringe may be stored for up to 7 days at room temperature (25 °C) prior to use.
• Store in the original packaging to protect from light.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Do not use any container that is damaged or shows signs of deterioration.

6. Contents of the pack and other information

Composition of Omlyclo

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

Appearance of Omlyclo and contents of the pack

Omlyclo for injection is presented as a solution that is clear to slightly opalescent, colourless to light yellowish-brown, in a pre-filled syringe.

Omlyclo 150 mg solution for injection is available in packs 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.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder

Celltrion Healthcare Hungary Kft.

1062 Budapest

Váci út 1-3. WestEnd Office Building B tower

Hungary

Manufacturer responsible for production

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

Further information on this medicine is available by contacting the local representative of the marketing authorization holder:

Belgium/Belgium/Belgium Celltrion Healthcare Belgium BVBA Tel/Tel: +32 1528 7418 [email protected]	Lithuania Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493
	Luxembourg/Luxembourg Celltrion Healthcare Belgium BVBA Tel/Tel: +32 1528 7418 [email protected]
Czech Republic Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493	Hungary Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493
Denmark Celltrion Healthcare Denmark ApS [email protected] Tlf: +45 3535 2989	Malta Mint Health Ltd. Tel: +356 2093 9800
Germany Celltrion Healthcare Deutschland GmbH Tel: +49 303 464 941 50 [email protected]	Netherlands Celltrion Healthcare Netherlands B.V. Tel: +31 20 888 7300 [email protected]
Estonia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 [email protected]	Norway Celltrion Healthcare Norway AS [email protected]
Spain CELLTRION FARMACEUTICA (SPAIN) S.L. Tel: +34 910 498 478 [email protected]	Austria Astro-Pharma GmbH Tel: +43 1 97 99 860
Greece BIANEX S.A. Tel: +30 210 8009111 - 120	Poland Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493
France Celltrion Healthcare France SAS Tel.: +33 (0)1 71 25 27 00	Portugal CELLTRION PORTUGAL, UNIPESSOAL LDA Tel: +351 21 936 8542 [email protected]
Croatia Oktal Pharma d.o.o. Tel: +385 1 6595 777	Romania Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493
Ireland Celltrion Healthcare Ireland Limited Tel: +353 1 223 4026 [email protected]	Slovenia OPH Oktal Pharma d.o.o. Tel.: +386 1 519 29 22
Iceland Celltrion Healthcare Hungary Kft. Sími: +36 1 231 0493 [email protected]	Slovakia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493
Italy Celltrion Healthcare Italy S.R.L. Tel: +39 0247927040 [email protected]	Finland Celltrion Healthcare Finland Oy. Puh/Tel: +358 29 170 7755 [email protected]
Cyprus C.A. Papaellinas Ltd Tel: +357 22741741	Sweden Celltrion Sweden AB Tel: +46 8 80 11 77 [email protected]
Latvia Celltrion Healthcare Hungary Kft. Talr.: +36 1 231 0493

Date of the most recent review of this leaflet: 10/2025

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

INSTRUCTIONS FOR USE OF OMLYCLO PRE-FILLED SYRINGE

Read and follow the instructions for use provided with Omlyclo pre-filled syringe before starting to use it and each time you receive a refill. They may contain new information.

This information does not replace consultation with your healthcare professional regarding your illness or treatment.

Children (aged 6 to 11 years) must not self-inject Omlyclo pre-filled syringe; however, if considered appropriate by a healthcare professional, a caregiver may administer the injection after receiving adequate training.

Omlyclo pre-filled syringe is available in 2 concentrations (see Figure A). These instructions should be followed for the 150 mg/1 ml concentration. The type of pre-filled syringe you receive will depend on the dose prescribed by your healthcare professional (see Figure C: Dosing Table). Check the packaging label and the plunger rod color to ensure the correct concentration.

Important safety information

• Keep the pre-filled syringe out of sight and reach of children. The pre-filled syringe contains small parts.
• Do not open the sealed package until you are ready to use the pre-filled syringe.
• Do not use the pre-filled syringe if it appears damaged or used.
• Do not use the pre-filled syringe if the packaging is damaged or the seal is broken.
• Do not leave the pre-filled syringe where others may handle it.
• Do not shake the pre-filled syringe.
• Do not remove the cap until immediately before administering the injection.
• The pre-filled syringe cannot be reused. Dispose of the used pre-filled syringe immediately into a sharps container after use (see step 13. Disposal of the pre-filled syringe).

Storage of the pre-filled syringe

• Store the pre-filled syringe in the refrigerator at 2 °C to 8 °C. Keep this medicine in its original packaging to protect it from light.
• Do not freeze the pre-filled syringe.
• Remember to remove the pre-filled syringe from the refrigerator and allow it to reach room temperature (25 °C) for about 30 minutes before preparing it for injection. Leave the pre-filled syringe in its packaging to protect it from light.
• Before administering the injection, you may remove the package from the refrigerator and return it if necessary. The total combined 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 use the pre-filled syringe after the expiry date stated on the packaging and on the label of the pre-filled syringe. If expired, return the entire package to the pharmacy.
• Do not use the pre-filled syringe if it has been dropped or is visibly damaged.

Parts of the pre-filled syringe (seeFigure B )

Injection Preparation	Gather the materials for the injection 1.a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area. 1.b. Remove from the refrigerator the container(s) containing the required pre-filled syringe(s) needed to administer your prescribed dose. Note: Depending on the dose prescribed by your healthcare provider, you may need to prepare one or more pre-filled syringes and inject the contents of all of them. The following table shows how many injections of each concentration are required for the prescribed dose (see Figure C: Dosage Table). 1.c. Make sure you have the following materials: Container containing the pre-filled syringe Not included in the container: 1 alcohol wipe 1 cotton ball or gauze pad 1 adhesive bandage Sharps container for sharp objects
	Check the expiration date on the container (see Figure D). Do not use if the expiration date has passed. If the expiration date has passed, return the entire container to the pharmacy.
	Wait 30 minutes. 3.a. Leave the unopened container containing the pre-filled syringe at room temperature (25°C) for 30 minutes to allow it to warm up (see Figure E). Do not heat the pre-filled syringe using 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 make it difficult to push the plunger.
	Wash your hands. 4.a. Wash your hands thoroughly with soap and water and dry them well (see Figure F).
	Choose an injection site (see Figure G) 5.a. You may inject yourself in: The front of the thighs. The lower abdomen, except within 5 cm around the navel. The outer upper arm area, if you are a caregiver or healthcare professional. Do not administer the injection into moles, scars, bruises, or areas where the skin is tender, red, hard, or cracked. Do not administer the injection through clothing. 5.b. Choose a different injection site for each new injection, at least 2.5 cm away from the site used for the previous injection.
	Clean the injection site. 6.a. Clean the injection site with an alcohol wipe using a circular motion (see Figure H). 6.b. Allow the skin to dry before injecting. Do not blow on or touch the injection site before administering the injection.
	Inspect the pre-filled syringe. 7.a. Open the container. Grasp the body of the pre-filled syringe to lift it out of the container. 7.b. Examine the pre-filled syringe and confirm it contains the correct medication (Omlyclo) and dose. 7.c. Check the pre-filled syringe to ensure it is not cracked or damaged. 7.d. Check the expiration date on the label of the pre-filled syringe (see Figure I). Do not use if the expiration date has passed. Note: If the expiration date is not visible in the viewing window, you may rotate the inner cylinder of the pre-filled syringe until the expiration date becomes visible.
	Inspect the medication. 8.a. Examine the medication and confirm the liquid is from transparent to slightly cloudy, colorless to light yellowish-brown, and free of particles (see Figure J). Do not use the pre-filled syringe if the liquid has changed color, is clearly cloudy, or contains particles. It is normal to see small air bubbles in the liquid.
Administering the Injection	Remove the cap. 9.a. Hold the pre-filled syringe by the body with one hand. With the other hand, gently pull the cap straight off. Do not touch the plunger rod while removing the cap. It is normal to see a few drops of liquid at the needle tip. 9.b. Immediately discard the cap into a sharps container (see step 13. Disposing of the Pre-filled Syringe and Figure K). Do not recap the pre-filled syringe. Do not remove the cap until you are ready to administer the injection. Do not touch the needle, as you may accidentally prick yourself.
	Insert the pre-filled syringe into the injection site. 10.a. Gently pinch with one hand a fold of skin at the injection site. Note: Pinching the skin is important to ensure the medication is injected under the skin (into the fatty layer) and not deeper (into the muscle). 10.b. With a quick, dart-like motion, insert the needle fully into the skin fold at an angle of 45 to 90 degrees (see Figure L). Do not press the plunger rod while inserting the needle into the skin.
	Administer the injection. 11.a. Once the needle is inserted, release the skin pinch. 11.b. Slowly push the plunger rod downward until the full dose of medication is injected and the syringe is empty (see Figure M). Do not move the position of the pre-filled syringe once the injection has started. If the plunger rod is not fully depressed, the needle shield will not extend to cover the needle upon removal.
	Remove the pre-filled syringe from the injection site. 12.a. Once the pre-filled syringe is empty, slowly lift your thumb off the plunger rod until the needle is fully covered by the needle shield (see Figure N). If the needle is not fully covered, handle with care when disposing of the syringe (see step 13. Disposing of the Pre-filled Syringe). Minor bleeding may occur (see step 14. Injection Site Care). If medication comes into contact with the skin, wash the area with water. Do not reuse the pre-filled syringe. Do not rub the injection site.
After the Injection	Dispose of the pre-filled syringe. 13.a. Immediately place the used pre-filled syringe into a sharps container after use (see Figure O). Do not throw (discard) the pre-filled syringe in household trash. If you do not have a sharps container, you may use a household container that can be closed and is puncture-resistant. For your safety, health, and the safety of others, used needles and syringes must never be reused. Disposal of unused medication and all materials that have come into contact with it must be in accordance with local regulations. Medications must not be flushed down drains or thrown into the trash. Ask your pharmacist how to dispose of unused containers and medications. This helps protect the environment.
Injection site care. 14.a. If bleeding occurs, apply gentle pressure (without rubbing) to the injection site using a cotton ball or gauze pad, and apply an adhesive bandage if needed.