OMLYCLO 75 mg Injectable Solution in Pre-filled Syringe

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 immune system attacks parts of your body (autoimmune disease),
• if you are going to travel to a region 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 using a medicine, an insect bite or food.

Omlyclo does not treat the symptoms of acute asthma, 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.

Monitor for signs of allergic reactions and other serious side effects

Omlyclo may cause serious side effects. You should monitor 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, or if you are not a healthcare professional, 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.

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 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, 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.

For 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

Your doctor will decide how much Omlyclo you need and how often you should 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 medication while using Omlyclo. Do not stop any asthma and/or nasal polyp medication 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 observed 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.

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 medication, but whose asthma symptoms are not well controlled by medicines such as high-dose inhaled steroids 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 considers it appropriate, 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.

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 missed injecting 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 using Omlyclo

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

If you have any other questions about using 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 can occasionally 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
• upper stomach pain
• 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 of hands or feet
• fainting, low blood pressure when sitting or standing up (postural hypotension), flushing
• sore throat, cough, acute respiratory problems
• feeling sick (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 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. Storing 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 the month shown. The carton containing the pre-filled syringe can be stored for a total of 7 days at room temperature (25 °C) before use.
• Store in the original package to protect from light.
• Store in a refrigerator (between 2 °C and 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 0.5 ml solution syringe contains 75 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 75 mg injectable solution is available in containers containing 1 pre-filled syringe.

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 medication 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 the Omlyclo pre-filled syringe before starting to use it and each time you receive 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 75 mg/0.5 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 ready 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 notleave 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. Disposing 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 medication 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. Leave 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)