OMLYCLO 150 MG READY-TO-USE INJECTION SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Omlyclo 150 mg solution for injection in pre-filled syringe

omalizumab

This medicine is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Omlyclo and what is it used for

Omlyclo contains the active substance omalizumab. Omalizumab is a human protein, similar to the 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 sinuses) with nasal polyps
• chronic spontaneous urticaria (CSU)

Allergic asthma

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

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) 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 you use Omlyclo

Do not use Omlyclo

• if you are allergic to omalizumab or any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic to any of the ingredients, tell your doctor, as you should not use Omlyclo.

Warnings and precautions

Tell your doctor before using Omlyclo:

• if you have kidney or liver problems,
• if you have a condition where your own immune system attacks parts of your own body (autoimmune disease),
• if you are going to travel to an area where parasitic infections are common, as Omlyclo may reduce your resistance to such infections,
• if you have had a severe allergic reaction (anaphylaxis) in the past, for example as a result of taking 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 this type of symptom.

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

Watch for signs of allergic reactions and other serious side effects

Omlyclo may cause serious side effects. You should watch for signs of these effects while using Omlyclo. Seek medical attention immediately if you notice any signs that indicate a serious allergic reaction or other serious side effects. These signs are mentioned in “Serious side effects” in section 4.

Before you or someone else injects Omlyclo, it is important that you receive training from your doctor on how to recognize the early symptoms of serious allergic reactions and how to act 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 in children under 6 years of age has not been studied.

Chronic rhinosinusitis with nasal polyps

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

Chronic spontaneous urticaria (CSU)

Omlyclo is not recommended for children under 12 years of age. Its use in children under 12 years of age 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 using:

• medicines to treat a parasitic infection, as Omlyclo may reduce the effect of your 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 have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the 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, ask your doctor for advice before taking this medicine.

Driving and using machines

Omlyclo is unlikely to affect your ability to drive or use machines.

3. How to use Omlyclo

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, ask your doctor, pharmacist or nurse again.

How to use Omlyclo

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

Omlyclo injection

• You and your doctor will decide if you will inject Omlyclo yourself. The first three doses will always be injected under the supervision of a healthcare professional (see section 2).
• It is important that you have received proper training on how to inject the medicine before you do it yourself.
• The caregiver (e.g. parents) can give the Omlyclo injection after proper training.

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

Training to recognize serious allergic reactions

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

• how to recognize the signs and symptoms of serious allergic reactions,
• what to do if the symptoms appear.

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

How much to use

Allergic asthma and chronic rhinosinusitis with nasal polyps

Your doctor will decide how much Omlyclo you need and how often you need to use it. This depends on your body weight and the results of a blood test done before starting treatment to determine the level of IgE in your blood.

You will need between 1 and 4 injections at the same time. You will need injections every 2 or 4 weeks.

Continue taking your current asthma and/or nasal polyp medicine while you are being treated with Omlyclo. Do not stop any asthma and/or nasal polyp medicine without talking to your doctor.

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

Chronic spontaneous urticaria (CSU)

You will need two 150 mg injections at the same time every 4 weeks.

Continue taking your current CSU medicine during treatment with Omlyclo. Do not stop any medicine without talking to your doctor.

Use in children and adolescents

Allergic asthma

Omlyclo can be used in children and adolescents from 6 years of age who are already taking asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will tell you how much Omlyclo your child needs and how often it should be given. This will depend on the child’s weight and the results of blood tests done before starting treatment to determine the level of IgE in the blood.

Children (from 6 to 11 years of age) are not expected to inject Omlyclo themselves. However, if the doctor thinks it is suitable, the caregiver can give the Omlyclo injection after proper training.

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 from 12 years of age who are already taking antihistamines but whose CSU symptoms are not well controlled by these medicines. The dose for adolescents from 12 years of age is the same as for adults.

If you miss a dose of Omlyclo

If you have missed a visit, contact your doctor or hospital as soon as possible to reschedule.

If you have forgotten to inject a dose of Omlyclo, inject it as soon as you remember. Then talk to your doctor to find out when you should have your next dose.

If you stop treatment with Omlyclo

Do not stop treatment with Omlyclo unless your doctor tells you to. Stopping or finishing treatment with Omlyclo may cause your symptoms to come back.

However, if you are being treated for CSU, your doctor may stop treatment with Omlyclo from time to time to assess your symptoms. Follow your doctor’s instructions.

If you have any other questions about the use of this medicine, ask 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 to moderate, but occasionally they can be serious.

Serious side effects:

Seek medical attention immediately if you notice any of the signs of the following side effects:

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

• serious 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 slight feeling of fainting, confusion, shortness of breath, wheezing or difficulty breathing, blue-tinged skin or lips, collapse and loss of consciousness. If you have a history of serious allergic reactions (anaphylaxis) not related to Omlyclo, you may be at greater risk of developing a serious allergic reaction after using Omlyclo.
• systemic lupus erythematosus (SLE). Symptoms may include muscle pain, pain and swelling of the joints, rash, fever, weight loss and fatigue.

Frequency not known (cannot be estimated from the available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. Symptoms may include one or more of the following: swelling, pain or rash around blood vessels or lymph nodes, high level of a specific type of white blood cell (marked eosinophilia), worsening of respiratory problems, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs.
• low blood platelet count with symptoms such as bleeding or bruising that occurs more easily than normal.
• serum sickness. Symptoms may include one or more of the following: joint pain with or without swelling or stiffness, rash, fever, swelling of the 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 including pain, swelling, itching and redness
• pain in the upper abdomen
• headache (very common in children)
• infections of the upper respiratory tract, such as pharyngitis and common cold
• feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache)
• joint pain (arthralgia)
• feeling of dizziness

Uncommon (may affect up to 1 in 100 people)

• feeling of sleepiness or tiredness
• tingling or numbness of hands or feet
• fainting, decrease in blood pressure when sitting or standing up (postural hypotension), flushing
• sore throat, cough, acute respiratory problems
• feeling of nausea, diarrhea, indigestion
• itching, hives, rash, increased sensitivity of the skin to the sun
• weight gain
• flu-like symptoms
• swollen arms

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

• parasitic infection

Frequency not known (cannot be estimated from the available data)

• muscle pain and joint inflammation
• hair loss

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 which is stated on the label after EXP. The expiry date is the last day of the month stated.
• Store in the original package to protect from light.
• Store in a refrigerator (2°C - 8°C). Do not freeze.
• Do not use any packaging that is damaged or shows signs of deterioration.

6. Container Contents and Additional Information

Composition of Omlyclo

• The active ingredient is omalizumab. A 1 ml syringe of solution contains 150 mg of omalizumab.
• The other components are L-arginine hydrochloride, L-histidine monohydrate hydrochloride, L-histidine, polysorbate 20, and water for injectable preparations.

Appearance of Omlyclo and Container Contents

Omlyclo injectable solution is presented as a clear to turbid, colorless to light brownish-yellow solution in a pre-filled syringe.

Omlyclo 150 mg injectable solution is available in packs containing 1 pre-filled syringe and in multiple packs containing 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

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

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 get a replacement. They may contain new information.

This information does not replace consultation with your healthcare professional about your disease or treatment.

Children (from 6 to less than 12 years of age) should not self-inject Omlyclo pre-filled syringe; however, if the healthcare professional considers it appropriate, a caregiver may administer the injection after receiving proper 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 label on the container and the color of the plunger rod to ensure that the concentration is correct.

Important Safety Information

• Keep the pre-filled syringe out of sight and reach of children. The pre-filled syringe contains small parts.
• Do notopen the sealed container until you are about to use the pre-filled syringe.
• Do notuse the pre-filled syringe if the container seal or the plastic tray seal is broken, as it may not be safe to use.
• Do notever leave the pre-filled syringe in a place where others may handle it.
• Do notshake the pre-filled syringe.
• Do notremove the cap until just before administering the injection.
• The pre-filled syringe cannot be reused. Dispose of the used pre-filled syringe in a puncture-resistant container immediately after use (see step 13. Dispose of the pre-filled syringe).

Storage of the Pre-filled Syringe

• Store the pre-filled syringe in the refrigerator between 2 °C and 8 °C. Keep this medicine closed in its container to protect it from light.
• Do notfreeze the pre-filled syringe.
• Remember to remove the pre-filled syringe from the refrigerator and let it reach room temperature (25 °C) for about 30 minutes before preparing it for injection. Keep the pre-filled syringe in the container to protect it from light.
• The storage time of the pre-filled syringe at room temperature (25 °C) before use should not exceed 7 days.
• Do notuse the pre-filled syringe after the expiration date shown on the container and on the pre-filled syringe label. If it has expired, return the entire container to the pharmacy.
• Do notuse the pre-filled syringe if it has been dropped or is visibly damaged.

Parts of the Pre-filled Syringe (see Figure B)

• Country of registration
  Spain
• Active substance
  omalizumab
• Prescription required
  Yes
• Manufacturer
  Celltrion Healthcare Hungary Kft.
• Composition
  POLISORBATO 20 (0,40 mg mg)
• This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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