Omyclo 150 mg solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Omlyclo 150 mg solution for injection in a pre-filled pen
omalizumab
This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Omlyclo is and what it is used for
- What you need to know before using Omlyclo
- How to use Omlyclo
- Possible side effects
- How to store Omlyclo
- 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 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 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 corticosteroid spray), 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 nasal 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), which 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 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 an autoimmune disease (a condition in which your immune system attacks parts of your own body),
- 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 severe allergic reaction or other serious adverse effects. These signs are described under “Serious adverse effects” in section 4.
Before you or someone else (who is not a healthcare professional) administers an Omlyclo injection, it is important that you receive training from your doctor on how to recognize early symptoms of severe allergic reactions and what to do if they occur (see section 3, “How to use Omlyclo”). Most severe 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 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 plan 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.
Tell your doctor immediately if you become pregnant while being treated with Omlyclo.
Omlyclo may pass into breast milk. If you are breastfeeding or plan to breastfeed, talk to your doctor 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 0.40 mg of polysorbate 20 in each pre-filled pen, equivalent to 0.40 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you or your child has 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 (e.g., 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 pre-filled pen" at the end of this leaflet.
Training to recognize 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 decide how much 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 require 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 injections of 150 mg 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 how much 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 considered appropriate by the doctor, a caregiver may administer the Omlyclo injection after proper training.
Omlyclo pre-filled pens should not be used in children under 12 years of age. Omlyclo 75 mg in pre-filled syringe and Omlyclo 150 mg in pre-filled syringe can be used in children aged 6 to 11 years with allergic asthma.
Chronic rhinosinusitis with nasal polyps
Omlyclo should 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 using Omlyclo
Do not stop treatment with Omlyclo unless instructed by your doctor. Stopping or discontinuing treatment with Omlyclo may cause your symptoms to return.
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 may cause adverse effects, although not everyone experiences them. The adverse effects caused by Omlyclo are generally mild to moderate, but occasionally they can be serious.
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 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
- sensation 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 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 package containing the pre-filled pen may be stored for up to 7 days at room temperature (25 °C) before 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 pre-filled pen 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 brownish-yellow, in a pre-filled pen.
Omlyclo 150 mg solution for injection is available in packs containing 1 pre-filled pen and 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 more information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Belgium/Belgium/Belgium Celltrion Healthcare Belgium BVBA Tel/Tel: +32 1528 7418 | Lithuania Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
| Luxembourg/Luxembourg Celltrion Healthcare Belgium BVBA Tel/Tel: +32 1528 7418 |
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 Tlf: +45 3535 2989 | Malta Mint Health Ltd. Tel: +356 2093 9800 |
Germany Celltrion Healthcare Deutschland GmbH Tel: +49 303 464 941 50 | Netherlands Celltrion Healthcare Netherlands B.V. Tel: +31 20 888 7300 |
Estonia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 | Norway Celltrion Healthcare Norway AS [email protected] |
Spain CELLTRION FARMACEUTICA (SPAIN) S.L. Tel: +34 910 498 478 | 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 |
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 | Slovenia OPH Oktal Pharma d.o.o. Tel.: +386 1 519 29 22 |
Iceland Celltrion Healthcare Hungary Kft. Sími: +36 1 231 0493 | Slovakia Celltrion Healthcare Hungary Kft. Tel: +36 1 231 0493 |
Italy Celltrion Healthcare Italy S.R.L. Tel: +39 0247927040 | Finland/Finland Celltrion Healthcare Finland Oy. Puh/Tel: +358 29 170 7755 |
Cyprus C.A. Papaellinas Ltd Tel: +357 22741741 | Sweden Celltrion Sweden AB Tel: +46 8 80 11 77 |
Latvia Celltrion Healthcare Hungary Kft. Tel.: +36 1 231 0493 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu
INSTRUCTIONS FOR USE OF OMLYCLO IN PRE-FILLED PEN
Read and follow the instructions for use provided with the Omlyclo pre-filled pen before starting to use it and each time you receive a refill. They may contain new information. Before using Omlyclo, ensure that your healthcare professional has shown you how to use it correctly.
Adolescents aged 12 years and older: They may self-administer the Omlyclo pre-filled pen under the supervision of an adult. The Omlyclo pre-filled pen (all doses) is intended for use only in adults and adolescents aged 12 years and older.
Parts of the pre-filled pen (see Figure A)
Select the correct pre-filled pen or combination of pre-filled pens
Omlyclo pre-filled pens are available in 2 concentrations (see Figure B).
These instructions apply to both concentrations.
You may need more than one injection to achieve your prescribed dose. The dosing table below (Figure C) shows the combination of pre-filled pens required to administer your complete dose. Check the label on the Omlyclo packaging to ensure you have the correct pre-filled pen or combination of pre-filled pens for your prescribed dose. If more than one injection is required for your dose, administer all necessary injections consecutively, one immediately after the other. If in doubt, contact your healthcare professional.
Dosing Table
Note: Your healthcare professional may prescribe a different combination of pre-filled pens required for your complete dose.
Storage of Omlyclo
- Store the unused pre-filled pen in its original packaging in the refrigerator at 2 °C to 8 °C.
- Before administering an injection, you may remove the packaging from the refrigerator and return it 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 its original packaging during storage.
- Keep the pre-filled pen away from direct sunlight.
- Do not freeze the pre-filled pen. Do not use the pre-filled pen if it has been frozen.
- Keep the pre-filled pen, the sharps container, and all medicines out of sight and reach of children.
Important information
- Do not use the pre-filled pen if the packaging is damaged or appears to have been tampered with.
- Do not open the packaging until you are ready to administer the injection.
- Do not use the pre-filled pen if it is damaged or appears to have been tampered with.
- Do not remove the pen cap until you are ready to inject Omlyclo.
- Do not use the pre-filled pen if it has been dropped on a hard surface or after the cap has been removed.
- Do not attempt to disassemble the pre-filled pen under any circumstances.
- Do not clean or touch the needle shield.
Preparation for Injection
1a. If you need more than 1 pre-filled pen to administer your prescribed dose (see Figure C), remove all required containers from the refrigerator at the same time (each container holds 1 pre-filled pen). You must follow the next steps for each pre-filled pen. | |
|
Figure D). 2a. Container holding the Omlyclo pre-filled pen Omlyclo Not included in the package:
Note: You may need more than 1 Omlyclo pre-filled pen for your prescribed dose. Refer to the Dosage Table (Figure C) for more information. Each Omlyclo package contains 1 pre-filled pen. |
|
|
|
4a. Place the container on a clean, flat surface for 30 to 45 minutes to allow the pre-filled pen to warm to room temperature naturally. Keep the pre-filled pen in the container to protect it from light (see Figure F).
|
|
5a. Wash your hands with soap and water. 5b. Hold the pre-filled pen by the middle and remove it from the container (see Figure G).
|
|
6a. Through the viewing window of the pre-filled pen, confirm that the liquid is clear to slightly cloudy, colorless to pale yellowish-brown, and free of particles or flakes. You may see air bubbles in the liquid. This is normal (see Figure H).
6b. Check the expiration date on the pre-filled pen.
6c. Check that the pre-filled pen is not damaged or has not been tampered with.
6d. If the medication does not look as described or if the expiration date has passed, carefully dispose of the pre-filled pen in a sharps disposal container (see Step 17) and contact your healthcare provider. |
|
(see Figure I). 7a. Recommended injection sites are:
|
|
8a. Clean the injection site with an alcohol wipe using a circular motion and allow it to dry for 10 seconds (see Figure J).
|
Administering the Injection
|
9a. Hold the pre-filled pen firmly in one hand and gently pull off the cap with the other hand (see Figure K).
9b. Dispose of the cap in household trash.
|
|
10a. Hold the pre-filled pen comfortably and place it directly on the skin, positioning it so you can see the viewing window. 10b. Place the pre-filled pen on the skin at a 90-degree angle without pinching or stretching the skin (see Figure L). |
|
11a. Press and hold the pre-filled pen firmly against the skin. The first “click” indicates that the injection has started (see Figure M). 11b. Hold the pre-filled pen firmly in place without moving it.
|
|
12a. Continue holding the pre-filled pen against the skin. You will see the blue indicator move across the viewing window (see Figure N). |
|
13a. Wait until you hear a second “click.” This indicates that the injection is nearly complete (see Figure O). 13b. After hearing the second “click,” continue holding the pre-filled pen firmly in place without moving it and count slowly to 5 to ensure the full dose is delivered (see Figure O). 13c. Keep the pre-filled pen in place until the blue indicator stops moving and completely fills the viewing window to ensure the injection is fully completed. |
|
14a. Once the blue indicator stops moving and completely fills the viewing window, lift the pre-filled pen perpendicularly away from the skin. The needle shield will automatically extend to cover the needle and lock into place.
|
15a. If minor bleeding or a drop of liquid appears at the injection site, gently press (without rubbing) with a cotton ball or gauze pad and apply an adhesive bandage if needed.
15b. If the medication comes into contact with the skin, wash the affected area with water. | |
16a. Dispose of used pre-filled pens as described in Step 17 and Figure Q. 16b. Repeat all steps from Step 2 to Step 15 for the next injection using a new pre-filled pen. 16c. Choose a different injection site for each new injection, at least 2 cm away from previous injection sites. 16d. Complete all required injections for your prescribed dose, one immediately after another. If in doubt, contact your healthcare provider. | |
After the Injection
|
17a. Immediately after use, place the used pre-filled pen and other used materials into a sharps disposal container (see Figure Q).
If you do not have a sharps disposal container, you may use a household container:
Consult your doctor or pharmacist about proper disposal of the sharps container. Local regulations may apply. |
