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Omlyclo 75mg solution for injection pre-filled pen {equilateral_black_triangle}

Active Ingredient:
omalizumab
Company:  
Celltrion Healthcare UK Limited See contact details
ATC code: 
R03DX05
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 07 Jul 2025

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 51808/0038.

{printer} Print patient leaflet as text only

Omlyclo 75mg solution for injection, pre-filled pen

Package leaflet: Information for the user

Omlyclo 75 mg solution for injection in pre-filled pen

omalizumab

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for 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.

What is in this leaflet

1. What Omlyclo is and what it is used for
2. What you need to know before you use 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 man-made protein that is 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 sinuses) with nasal polyps

Allergic asthma

This medicine is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults, adolescents and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers and beta-agonist inhalers.

Chronic rhinosinusitis with nasal polyps

This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (18 years of age and older) who are already receiving intranasal corticosteroids (corticosteroid nasal spray), but whose symptoms are not well controlled by these medicines. Nasal polyps are small growths on 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 runny nose.

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 and chronic rhinosinusitis with nasal polyps.

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). (See special warnings at the end of this section under subtitle “Omlyclo contains polysorbate”)

If you think you may be allergic to any of the ingredients, tell your doctor as you should 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 where your own immune system attacks parts of your own body (autoimmune disease).
  • if you are travelling to region where infections caused by parasites are common - Omlyclo may weaken your resistance to such infections.
  • if you have had a previous severe allergic reaction (anaphylaxis), for example resulting from a medicine, an insect bite or food.

Omlyclo does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Omlyclo should not be used to treat such symptoms.

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

Look out for signs of allergic reactions and other serious side effects

Omlyclo can potentially cause serious side effects. You must look out for signs of these conditions while you use Omlyclo. Seek medical help immediately if you notice any signs indicating a severe allergic reaction or other serious side effects. Such signs are listed under “Serious side effects” in section 4.

It is important that you receive training from your doctor in how to recognise early symptoms of severe allergic reactions, and how to manage these reactions if they occur, before you inject Omlyclo yourself or before a non-healthcare professional gives you a Omlyclo injection (see section 3, “How to use Omlyclo”). The majority of 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. 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 taking:

  • medicines to treat an infection caused by a parasite, as Omlyclo may reduce the effect of your medicines,
  • inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, 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, tell your doctor immediately.

Omlyclo may pass into breast milk. If you are breast-feeding or plan to breast-feed, ask your doctor for advice before using this medicine.

Driving and using machines

It is unlikely that Omlyclo will affect your ability to drive and use machines.

Omlyclo contains polysorbate

This medicine contains 0.20 mg of polysorbate 20 in each pre-filled pen, which is equivalent to 0.40 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you or your child has any known allergies

3. How to use Omlyclo

Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

How Omlyclo is used

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

Injecting Omlyclo

  • You and your doctor will decide if you should inject Omlyclo yourself. The first 3 doses are always given by or under the supervision of a healthcare professional (see section 2).
  • It is important to be properly trained on how to inject the medicine before injecting yourself.
  • A caregiver (for example a parent) may also give you your Omlyclo injection after he or she has received proper training.

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

Training to recognise serious allergic reactions

It is also important that you do not inject Omlyclo yourself until you have been trained by your doctor or nurse on:

  • how to recognise the early signs and symptoms of serious allergic reactions.
  • what to do if the symptoms occur.

For more information about the early 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 will need it. This depends on your body weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in your blood.

You will need 1 to 4 injections at a time. You will need the injections either every two weeks, or every four weeks.

Keep taking your current asthma and/or nasal polyps medicine during Omlyclo treatment. Do not stop taking any asthma and/or nasal polyps medicine without talking to your doctor.

You may not see an immediate improvement after beginning Omlyclo treatment. In patients with nasal polyps effects have been seen 4 weeks after the start of the treatment. In asthma patients it usually takes between 12 and 16 weeks to have the full effect.

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 medicine, but whose asthma symptoms are not well controlled by medicines such as high dose steroid inhalers and beta-agonist inhalers. Your doctor will work out how much Omlyclo your child needs and how often it needs to be given. This will depend on your child’s weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in his/her blood.

Children (6 to 11 years of age) should not self-administer Omlyclo. However, if considered appropriate by their doctor, a caregiver may give them their Omlyclo injection after proper training.

Omlyclo pre-filled pens are not intended for use in children under 12 years of age. Omlyclo 75 mg pre-filled syringe and Omlyclo 150 mg pre-filled syringe may be used in children 6-11 years of age with allergic asthma.

Chronic rhinosinusitis with nasal polyps

Omlyclo should not be used in children and adolescents under 18 years of age.

If a dose of Omlyclo is missed

If you have missed an appointment, contact your doctor or hospital as soon as possible to re-schedule it.

If you have forgotten to give yourself a dose of Omlyclo, inject the dose as soon as you remember. Then talk to your doctor to discuss when you should inject the next dose.

If you stop treatment with Omlyclo

Do not stop treatment with Omlyclo unless your doctor tells you to. Interrupting or stopping the treatment with Omlyclo may cause your symptoms to come back.

If you have any further questions on 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 can occasionally be serious.

Serious side effects:

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

Rare (may affect up to 1 in 1000 people)

  • Severe allergic reactions (including anaphylaxis). Symptoms may include rash, itching or hives on the skin, swelling of the face, lips, tongue, larynx (voice box), windpipe or other parts of the body, fast heartbeat, dizziness and light-headedness, confusion, shortness of breath, wheezing or trouble breathing, blue skin or lips, collapsing and losing consciousness. If you have a history of severe allergic reactions (anaphylaxis) unrelated to Omlyclo you may be more at 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 the 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, high level of a specific type of white blood cells (marked eosinophilia), worsening problems with breathing, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs.
  • Low blood 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 swelling or stiffness, rash, 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 including pain, swelling, itching and redness
  • pain in the upper part of the tummy
  • headache (very common in children)
  • feeling dizzy
  • pain in joints (arthralgia)

Uncommon (may affect up to 1 in 100 people)

  • feeling sleepy or tired
  • tingling or numbness of the hands or feet
  • fainting, low blood pressure while sitting or standing (postural hypotension), flushing
  • sore throat, coughing, acute breathing problems
  • feeling sick (nausea), diarrhoea, indigestion
  • itching, hives, rash, increased sensitivity of the skin to sun
  • weight increase
  • flu-like symptoms
  • swelling arms

Rare (may affect up to 1 in 1000 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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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. The carton containing the pre-filled pen can be stored for a total time of 7 days at room temperature (25 °C) before use.
  • Store in the original package in order to protect from light.
  • Store in a refrigerator (2 °C - 8 °C). Do not freeze.
  • Do not use any pack that is damaged or shows signs of tampering.

6. Contents of the pack and other information
What Omlyclo contains
  • The active substance is omalizumab. One pen of 0.5 ml solution contains 75 mg omalizumab.
  • The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, L-histidine, Polysorbate 20 (E 432) and water for injections.

What Omlyclo looks like and contents of the pack

Omlyclo solution for injection is supplied as a clear to slightly cloudy, colourless to pale brownish-yellow solution in a pre-filled pen.

Omlyclo 75 mg solution for injection is available in a pack containing 1 pre-filled pen.

Marketing Authorisation Holder
Celltrion Healthcare United Kingdom Limited
The Charter Building
Charter Place
Uxbridge
UB8 1JG
United Kingdom

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 Fatjo 7b
Parc Tecnologic Del Valles
08290 Cerdanyola Del Valles
Barcelona
Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Celltrion Healthcare United Kingdom Limited
Tel: +44 (0)1753 983500

This leaflet was last revised in 04/2025

Celltrion Healthcare UK Limited
Company image
Address
Celltrion Healthcare UK Limited, The Charter Building, Charter Place, Uxbridge, UB8 1JG, UK
WWW
http://www.celltrionhealthcare.co.uk/
Telephone
01753 983 500
Medical Information Direct Line
01753 983 500
Medical Information e-mail
[email protected]
Customer Care direct line
01753 983 500
Adverse event reporting email
[email protected]