Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Omlyclo 150 mg solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Omalizumab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 – 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 (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. Chronic spontaneous urticaria (CSU) This medicine is used to treat chronic spontaneous urticaria in adults and adolescents (12 years of age and older) who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines. 1
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, chronic rhinosinusitis with nasal polyps and CSU. 2.
What you need to know before you take it
e 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 fungusrelated 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. 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.
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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 Each Omlyclo 150 mg pre-filled syringe contains 0.40 mg of polysorbate 20 and each Omlyclo 300 mg pre-filled syringe contains 0.80 mg of polysorbate 20, 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 to take it
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 syringe" 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.
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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 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. Chronic spontaneous urticaria (CSU) You will need two 150 mg injections at a time or one 300 mg injection every four weeks. Keep taking your current medicine for CSU during Omlyclo treatment. Do not stop taking any medicine without talking to 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 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 300 mg pre-filled syringe is 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. Chronic spontaneous urticaria (CSU) Omlyclo can be used in adolescents aged 12 years of age and older, who are already receiving antihistamines but whose CSU symptoms are not well controlled by these medicines. The dose for adolescents aged 12 years and above is the same as for adults. If you use more Omlyclo than you should If you have used or been given too much Omlyclo, talk to a doctor or pharmacist straight away. Always have the outer carton of the medicine with you, even if it is empty. 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.
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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. However, if you are being treated for CSU, your doctor may stop Omlyclo treatment from time to time so that your symptoms can be assessed. Follow your doctor's instructions. 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) – upper respiratory tract infection, such as inflammation of the pharynx and common cold – feeling of pressure or pain in the cheeks and forehead (sinusitis, sinus headache) – pain in joints (arthralgia) – feeling dizzy 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 5
– –
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 it
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 syringe 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 syringe of 1 ml solution contains 150 mg omalizumab. One syringe of 2 ml solution contains 300 mg omalizumab. The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride monohydrate, Lhistidine, 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 brownishyellow solution in a pre-filled syringe. Omlyclo 150 mg solution for injection is available in a pack containing 1 pre-filled syringe and in multipacks containing 6 (6 x 1) or 10 (10 x 1) pre-filled syringes. Omlyclo 300 mg solution for injection is available in a pack containing 1 pre-filled syringe and in multipacks containing 2 (2 x 1), 3 (3 x 1) or 6 (6 x 1) pre-filled syringes. Not all pack sizes may be marketed in your country. Marketing Authorisation Holder Celltrion Healthcare United Kingdom Limited The Charter Building, Charter Place, Uxbridge, UB8 1JG, United Kingdom Manufacturer
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Kymos S.L. Ronda de Can Fatjó 7B Parc Tecnològic del Vallès 08290 Cerdanyola Del Valles Barcelona Spain For any information about this medicine, please contact the Marketing Authorisation Holder: United Kingdom Celltrion Healthcare United Kingdom Limited Tel: +44 (0)1753 983500 This leaflet was last revised in 03/2026
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INSTRUCTIONS FOR USE OF OMLYCLO PRE-FILLED SYRINGE Read and follow the Instructions for Use that come with your Omlyclo Pre-filled Syringe before you start using it and each time you get a refill. There may be new information. Before you use Omlyclo Pre-filled Syringe for the first time, make sure your healthcare provider shows you the right way to use it. Children (6 to 11 years of age) should not inject Omlyclo Pre-filled Syringes themselves, however, if deemed appropriate by their healthcare provider, a caregiver may give them their injection after proper training. Parts of the Pre-filled Syringe (see Figure A)
Figure A Choose the Correct Pre-filled Syringe or Combination of Pre-filled Syringes Omlyclo Pre-filled Syringes are available in 3 dose strengths (see Figure B). These instructions are to be used for all dose strengths.
Figure B 8
Your prescribed dose may require more than 1 injection. The Dosing Table (Figure C) below shows the combination of Pre-filled Syringes needed to give your full dose. Check the label on the Omlyclo carton to make sure you have received the correct Pre-filled Syringe or combination of Pre-filled Syringes for your prescribed dose. If your dose requires more than 1 injection, complete all injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions.
!
Important: If the dose is for a child under age 12, it is recommended to use only yellow (75 mg) and blue (150 mg) Pre-filled Syringes, since white (300 mg) Pre-filled Syringe is not intended for use in patients under 12 years of age. Refer to the Dosing Table (Figure C) below for the recommended combination of Pre-filled Syringes for children under age 12.
Contact your healthcare provider if you have any questions on the Dosing Table. Dosing Table
Figure C Note: Your healthcare provider may prescribe a different combination of Pre-filled Syringes for your complete dose. 9
Important information you need to know before injecting Omlyclo • • • • • • • • • •
Omlyclo is for subcutaneous injection only (inject directly into fatty layer under the skin). The Pre-filled Syringe has a Safety Guard that will be activated to cover the Needle after the injection is finished. The Safety Guard will help to prevent needlestick injuries to anyone who handles the Pre-filled Syringe after injection. Do not open the sealed carton until you are ready to inject the Pre-filled Syringe. Do not use if the carton or the Pre-filled Syringe is damaged or appears to be tampered with. Do not take the Cap off until you are ready to inject the Pre-filled Syringe. Do not use if the Pre-filled Syringe has been dropped on a hard surface or dropped after removing the Cap. Do not reuse the same Pre-filled Syringe. Do not leave the Pre-filled Syringe unattended. Do not try to take the Pre-filled Syringe apart at any time. Do not pull back on the Plunger Rod.
How Should I Store Omlyclo? • Store the unused Pre-filled Syringes in the original carton in a refrigerator between 2 °C to 8 °C. • Do not remove the Pre-filled Syringe from its original carton during storage. • Keep the Pre-filled Syringe in the original carton until ready to use in order to protect from light. • Do not freeze. • Do not use if the Pre-filled Syringe has been frozen. • Before giving an injection, the carton can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 7 days. If the Pre-filled Syringe is exposed to temperatures above 25°C, do not use it and throw away in a sharps disposal container. • Keep the Pre-filled Syringe, sharps disposal container and all medicines out of sight and reach of children. Pre-filled Syringe contains small parts.
Preparing for the Injection 1.
Take the carton containing the Pre-filled Syringe out of the refrigerator and Allow the Pre-filled Syringe to reach room temperature.
a.
If you need more than 1 Pre-filled Syringe to deliver your prescribed dose (see Figure C), take all the cartons out of the refrigerator at the same time (each carton contains 1 Pre-filled Syringe). The following steps must be followed for each Pre-filled Syringe.
b.
Set aside the unopened carton on a clean, flat surface for at least 30 to 45 minutes to allow it to warm up. Leave the Pre-filled Syringe in the carton to protect it from light (see Figure D). ⚫
Figure D
⚫
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Do not warm the Pre-filled Syringe using heat sources such as hot water or a microwave. If the Pre-filled Syringe does not reach room temperature, this could cause the injection to feel uncomfortable and make it hard to push the Plunger Rod.
2.
Gather supplies needed to give your injection (see Figure E). Carton containing Pre-filled Syringe
⚫
Not included in the carton: – Alcohol swab – Cotton ball or gauze – Adhesive bandage – Sharps disposal container
⚫
Note: You may need more than 1 Pre-filled Syringe for your prescribed dose. See the Dosing Table (see Figure C) for more information. Each carton contains 1 Pre-filled Syringe.
Figure E 3.
Check the expiration date on the carton (see Figure F). ⚫
⚫
Do not use it if the expiration date has passed. If the expiration date has passed, safely dispose of the carton in a sharps disposal container (see Step16. Dispose of the Prefilled Syringe) and contact your healthcare provider.
Figure F 4.
Wash your hands. a.
Wash your hands with soap and water and dry them thoroughly (see Figure G).
Figure G
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5.
Remove the Pre-filled Syringe from the carton a.
Open the carton.
b.
Gripping from the syringe body lift the Pre-filled Syringe from the carton (see Figure H) Do not touch the Plunger Rod or Cap when removing the Pre-filled Syringe from carton.
⚫
Figure H 6.
Inspect the Pre-filled Syringe. a.
Look at the Pre-filled Syringe and make sure you have the correct Medicine (Omlyclo) and dosage.
b.
Look at the Pre-filled Syringe and make sure it is not cracked or damaged. Do not use if the Pre-filled Syringe is damaged or appears to be tampered with.
⚫
c.
Check the expiration date on the label of the Prefilled 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 barrel of the Pre-filled Syringe until the expiration date becomes visible.
Figure I 7.
Inspect the Medicine. a.
Look at the Medicine and confirm that the liquid is clear to slightly cloudy, colourless to pale brownish-yellow, and free of particles (see Figure J). Do not use the Pre-filled Syringe if the liquid is discoloured, distinctly cloudy, or contains particles in it.
⚫
You may see air bubbles in the liquid. This is normal.
⚫
Do not try to remove the air bubbles.
⚫
b.
Figure J
If the Medicine does not look as described or if the expiration date has passed, safely dispose of the Pre-filled Syringe in a sharps disposal container (see Step 16) and contact your healthcare provider.
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8.
Choose an injection site (see Figure K) a.
If you are giving yourself the injection, you can inject into: The front of the thighs. The lower stomach area (lower abdomen) except within the 5 cm area around your belly button (navel). If a caregiver or healthcare provider (HCP) is giving the injection, they can use: –
b.
–
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
⚫
Do not inject through clothing. The injection site should be exposed, clean skin.
⚫
Figure K
If your prescribed dose requires more than 1 injection, make sure your injections are at least 2 cm apart from each other.
⚫
9.
The outer area of the upper arm. The front of the thighs. The lower stomach area (lower abdomen) except within the 5 cm area around your belly button (navel).
Clean the injection site. a.
Clean the injection site with an alcohol swab using a circular motion (see Figure L).
b.
Let the skin dry 10 seconds before injecting. Do not fan or blow on the clean area.
⚫
Do not touch the injection site again before giving the injection.
⚫
Figure L
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Giving the Injection 10. Remove the Cap. a.
Hold the Pre-filled Syringe by the syringe body in one hand.
b.
Gently pull the Cap straight off with the other hand (see Figure M). Do not remove the Cap until you are ready to inject.
⚫
Do not twist the Cap.
⚫
Do not hold, push or pull the Plunger Rod while removing the Cap.
⚫
You may see a few drops of liquid at the tip of the Needle. This is normal.
⚫
c.
Dispose of the Cap right away in a sharps disposal container (see Step 16. Dispose of the Pre-filled Syringe and Figure M).
Figure M
Do not re-cap the Pre-filled Syringe.
⚫
Do not touch the needle or let it touch any surfaces after removing the Cap.
⚫
11. Insert the Pre-filled Syringe into the injection site. a.
Gently pinch a fold of skin at the injection site with one hand. Hold the pinched skin tightly until the injection is complete. Note: Pinching the skin is important to make sure that you inject under the skin (into the fatty area) but not any deeper (into muscle).
b.
With a quick and "dart-like" motion, insert the Needle all the way into the pinched skin at an angle of about 45-degrees (see Figure N). Note: It is important to use the correct angle to make sure the medicine is delivered under the skin (into the fatty area), or the injection could be uncomfortable and the medicine may not work. Do not touch the Plunger Rod while inserting the Needle into the skin.
⚫
Figure N
Do not insert the Needle through clothing.
⚫
Once the Needle is inserted, hold the Pre-filled Syringe tightly in place and do not change the angle of injection or insert the needle again. The patient should not move and should avoid sudden movements throughout the injection
⚫
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12. Give the injection. a.
Slowly push the Plunger Rod all the way down until the full dose of medicine gets injected, and the Pre-filled Syringe is empty (see Figure O). Do not change the position of the Pre-filled Syringe after the injection has started.
⚫
If the Plunger Rod is not fully pressed, the Safety Guard will not extend to cover the needle when it is removed.
⚫
Figure O 13. Remove the Pre-filled Syringe from the injection site. a.
After the Pre-filled Syringe is empty, slowly lift your thumb from the Plunger Rod until the Needle is completely covered by the Safety Guard (see Figure P). If the Needle is not covered, carefully remove the Pre-filled Syringe from the skin and dispose of the Pre-filled Syringe in a sharps disposal container (see Step 16. Dispose of the Pre-filled Syringe).
⚫
b.
Remove the Pre-filled Syringe from the injection site and release the pinch. Some bleeding may occur (see Step 14. Care for the injection site).
⚫
Figure P
Do not reuse the Pre-filled Syringe.
⚫
14. Care for the injection site. a.
If some bleeding occurs or there is a drop of liquid at the injection site, treat the injection site by gently pressing, not rubbing, a cotton ball or gauze to the site and apply an adhesive bandage if needed. ⚫
Do not rub the injection site.
b. In case of skin contact with Medicine, wash the area that touched the Medicine with water. 15. If your prescribed dose requires more than 1 injection: a.
Throw away the used Pre-filled Syringe as described in Step 16. Dispose of the Pre-filled Syringe.
b.
Repeat Step 2 through Step 14 for the next injection using a new Pre-filled Syringe. ⚫
⚫
⚫
Make sure each injection is at least 2 cm apart from each other. Complete all the required injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions.
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After the injection 16. Dispose of the Pre-filled Syringe. a.
Put the used Pre-filled Syringe in a sharps disposal container right away after use (see Figure Q). The Omlyclo Pre-filled Syringe is a singledose syringe and should not be used again.
⚫
Do not try to put the needle cap back onto the Pre-filled Syringe.
⚫
Do not throw away (dispose of) the Pre-filled Syringe in your household trash.
⚫
If you do not have a sharps disposal container, you may use a household container that is closable and puncture resistant.
⚫
Figure Q
Talk to your doctor or pharmacist about proper disposal of the sharps disposal container. There may be local regulations for disposal.
⚫
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Frequently asked questions about Omlyclo 150 mg solution for injection in pre-filled syringe
How do I take Omlyclo 150 mg solution for injection in pre-filled syringe?
Omlyclo 150 mg solution for injection in pre-filled syringe comes as injection containing 150mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Omlyclo 150 mg solution for injection in pre-filled syringe?
The active substance in Omlyclo 150 mg solution for injection in pre-filled syringe is omalizumab.
Are there equivalent medicines to Omlyclo 150 mg solution for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Omlyclo 150mg solution for injection pre-filled pen, Xolair 150 mg solution for injection in pre-filled syringe, Xolair 150mg solution for injection in pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Omlyclo 150 mg solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Omlyclo 150 mg solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: omalizumab
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Allergic asthma
Omlyclo is indicated in adults, adolescents and children (6 to < 12 years of age).
Omlyclo treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Adults and adolescents (12 years of age and older)
Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 < 80 %) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Children (6 to < 12 years of age)
Omlyclo is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Omlyclo is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control.
Chronic spontaneous urticaria (CSU)
Omlyclo is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
4.2. Posology and method of administration
Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic spontaneous urticaria.
Posology
Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
Dosing for allergic asthma and CRSwNP follows the same dosing principles. The appropriate dose and frequency of omalizumab for these conditions is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment. Based on these measurements, 75 to 600 mg of omalizumab in 1 to 4 injections may be needed for each administration.
Allergic asthma patients with baseline IgE lower than 76 IU/ml were less likely to experience benefit (see section 5.1). Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to < 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts.
Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given omalizumab.
The maximum recommended dose is 600 mg omalizumab every two weeks.
Table 1 Conversion from dose to number of syringes, number of injections** and total injection volume for each administration
Dose (mg)
Number of syringes
Number of injections**
Total injection volume (ml)
75 mg
150 mg
300 mg*
75
1
0
0
1
0.5
150
0
1
0
1
1.0
225
1
1
0
2
1.5
300
0
0
1
1
2.0
375
1
0
1
2
2.5
450
0
1
1
2
3.0
525
1
1
1
3
3.5
600
0
0
2
2
4.0
*Omlyclo 300 mg pre-filled syringe is not intended for use in patients <12 years of age.
**This table represents the least number of injections for the patients, however there are other syringe dosing combinations possible to achieve the desired dose.
Table 2 ADMINISTRATION EVERY 4 WEEKS. Omalizumab doses (milligrams per dose) administered by subcutaneous injection every 4 weeks
*Body weights below 30 kg were not studied in the pivotal trials for CRSwNP.
Table 3 ADMINSTRATION EVERY 2 WEEKS. Omalizumab doses (milligrams per dose) administered by subcutaneous injection every 2 weeks
*Body weights below 30 kg were not studied in the pivotal trials for CRSwNP.
Treatment duration, monitoring and dose adjustments
Allergic asthma
Omlyclo is intended for long-term treatment. Clinical trials have demonstrated that it takes at least 12 – 16 weeks for the treatment to show effectiveness. At 16 weeks after commencing Omlyclo therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered. The decision to continue treatment following the 16‑week timepoint, or on subsequent occasions, should be based on whether a marked improvement in overall asthma control is seen (see section 5.1, Physician's overall assessment of treatment effectiveness).
Chronic rhinosinusitis with nasal polyps (CRSwNP)
In clinical trials for CRSwNP, changes in nasal polyps score (NPS) and nasal congestion score (NCS) were observed at 4 weeks. The need for continued therapy should be periodically reassessed based upon the patient's disease severity and level of symptom control.
Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
Discontinuation of treatment generally results in a return to elevated free IgE levels and associated symptoms. Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if treatment has been interrupted for one year or more.
Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
Chronic spontaneous urticaria (CSU)
The recommended dose is 300 mg by subcutaneous injection every four weeks. Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Prescribers are advised to periodically reassess the need for continued therapy.
Clinical trial experience of long-term treatment in this indication is described in section 5.1.
Special populations
Elderly (65 years of age and older)
There are limited data available on the use of omalizumab in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.
Renal or hepatic impairment
There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab. Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment. While no particular dose adjustment is recommended for these patients, omalizumab should be administered with caution (see section 4.4).
Paediatric population
In allergic asthma, the safety and efficacy of omalizumab in patients below the age of 6 years have not been established. No data are available.
In CRSwNP, the safety and efficacy of omalizumab in patients below the age of 18 years have not been established. No data are available.
In CSU, the safety and efficacy of omalizumab in patients below the age of 12 years have not been established. No data are available.
Method of administration
For subcutaneous administration only. Omalizumab must not be administered by the intravenous or intramuscular route.
Omlyclo 300 mg pre-filled syringe are not intended for use in children <12 years of age. Omlyclo 75 mg pre-filled syringe and Omlyclo 150 mg pre-filled syringe may be used in children 6 to 11 years of age with allergic asthma.
If more than one injection is needed to achieve the required dose, injections should be divided across two or more injection sites (Table 1).
Patients with no known history of anaphylaxis may self-inject Omlyclo or be injected by a caregiver from the 4th dose onwards if a physician determines that this is appropriate (see section 4.4). The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions.
Patients or caregivers should be instructed to inject the full amount of Omlyclo according to the instructions provided in the package leaflet.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
General
Omalizumab is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Omalizumab has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis. Omalizumab is not indicated for the treatment of these conditions.
Omalizumab therapy has not been studied in patients with autoimmune diseases, immune complex-mediated conditions, or pre-existing renal or hepatic impairment (see section 4.2). Caution should be exercised when administering omalizumab in these patient populations.
Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of omalizumab therapy in allergic asthma or CRSwNP is not recommended. Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
Immune system disorders
Allergic reactions type I
Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock, may occur when taking omalizumab, even after a long duration of treatment. However, most of these reactions occurred within 2 hours after the first and subsequent injections of omalizumab but some started beyond 2 hours and even beyond 24 hours after the injection. The majority of anaphylactic reactions occurred within the first 3 doses of omalizumab. Therefore, the first 3 doses must be administered either by or under the supervision of a healthcare professional. A history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following omalizumab administration. Therefore for patients with a known history of anaphylaxis, omalizumab must be administered by a health care professional, who should always have medicinal products for the treatment of anaphylactic reactions available for immediate use following administration of omalizumab. If an anaphylactic or other serious allergic reaction occurs, administration of omalizumab must be discontinued immediately, and appropriate therapy initiated. Patients should be informed that such reactions are possible, and prompt medical attention should be sought if allergic reactions occur.
Antibodies to omalizumab have been detected in a low number of patients in clinical trials (see section 4.8). The clinical relevance of anti-omalizumab antibodies is not well understood.
Serum sickness
Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab. The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab. The onset has typically been 1 – 5 days after administration of the first or subsequent injections, also after long duration of treatment. Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy. Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.
Churg-Strauss syndrome and hypereosinophilic syndrome
Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), both of which are usually treated with systemic corticosteroids.
In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis. These events are commonly associated with the reduction of oral corticosteroid therapy.
In these patients, physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/or neuropathy.
Discontinuation of omalizumab should be considered in all severe cases with the above mentioned immune system disorders.
Parasitic (helminth) infections
IgE may be involved in the immunological response to some helminth infections. In patients at chronic high risk of helminth infection, a placebo-controlled trial in allergic patients showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered. The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients. However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic. If patients do not respond to recommended anti-helminth treatment, discontinuation of omalizumab should be considered.
Excipient with known effect
This medicine contains 0.40 mg of polysorbate 20 (E 432) in each pre-filled syringe, which is equivalent to 0.40 mg/ml. Polysorbates may cause allergic reactions. Patients with polysorbate allergy should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
Since IgE may be involved in the immunological response to some helminth infections, omalizumab may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions. Medicinal product or vaccine interaction studies have not been performed with omalizumab. There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma, CRSwNP or CSU will interact with omalizumab.
Allergic asthma
In clinical studies omalizumab was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta agonists, leukotriene modifiers, theophyllines and oral antihistamines. There was no indication that the safety of omalizumab was altered with these other commonly used anti-asthma medicinal products. Limited data are available on the use of omalizumab in combination with specific immunotherapy (hypo-sensitisation therapy). In a clinical trial where omalizumab was co-administered with immunotherapy, the safety and efficacy of omalizumab in combination with specific immunotherapy were found to be no different to that of omalizumab alone.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
In clinical studies omalizumab was used in conjunction with intranasal mometasone spray as per protocol. Other commonly used concomitant medicinal products included other intranasal corticosteroids, bronchodilators antihistamines, leukotriene receptor antagonists, adrenergics/sympathomimetics and local nasal anesthetics. There was no indication that the safety of omalizumab was altered by the concomitant use of these other commonly used medicinal products.
Chronic spontaneous urticaria (CSU)
In clinical studies in CSU, omalizumab was used in conjunction with antihistamines (anti-H1, anti-H2) and leukotriene receptor antagonists (LTRAs). There was no evidence that the safety of omalizumab was altered when used with these medicinal products relative to its known safety profile in allergic asthma. In addition, a population pharmacokinetic analysis showed no relevant effect of H2 antihistamines and LTRAs on omalizumab pharmacokinetics (see section 5.2).
Paediatric population
Clinical studies in CSU included some patients aged 12 to 17 years taking omalizumab in conjunction with antihistamines (anti-H1, anti-H2) and LTRAs. No studies have been performed in children under 12 years.
4.6. Fertility, pregnancy and lactation
Pregnancy
A moderate amount of data on pregnant women (between 300 – 1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity. A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to omalizumab showed the prevalence of major congenital anomalies was similar (8.1 % vs. 8.9 %) between EXPECT and disease-matched (moderate and severe asthma) patients. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Omalizumab crosses the placental barrier. However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals (see section 5.3).
If clinically needed, the use of omalizumab may be considered during pregnancy.
Breast-feeding
Immunoglobulins G (IgGs) are present in human milk and therefore it is expected that omalizumab will be present in human milk. Available data in non-human primates have shown excretion of omalizumab into milk (see section 5.3).
The EXPECT study, with 154 infants who had been exposed to omalizumab during pregnancy and through breast-feeding did not indicate adverse effects on the breast-fed infant. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design.
Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breast-fed newborns/infants are anticipated. Consequently, if clinically needed, the use of omalizumab may be considered during breast-feeding.
Fertility
There are no human fertility data for omalizumab. In specifically-designed non-clinical fertility studies, in non-human primates including mating studies, no impairment of male or female fertility was observed following repeated dosing with omalizumab at dose levels up to 75 mg/kg. Furthermore, no genotoxic effects were observed in a separate non-clinical genotoxicity study.
4.7. Effects on ability to drive and use machines
Omalizumab has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP)
Summary of the safety profile
During allergic asthma clinical trials in adult and adolescent patients 12 years of age and older, the most commonly reported adverse reactions were headaches and injection site reactions, including injection site pain, swelling, erythema and pruritus. In clinical trials in children 6 to < 12 years of age, the most commonly reported adverse reactions were headache, pyrexia and upper abdominal pain.
Most of the reactions were mild or moderate in severity. In clinical trials in patients ≥ 18 years of age in CRSwNP, the most commonly reported adverse reactions were headache, dizziness, arthralgia, abdominal pain upper and injection site reactions.
Tabulated list of adverse reactions
Table 4 lists the adverse reactions recorded in clinical studies in the total allergic asthma and CRSwNP safety population treated with omalizumab by MedDRA system organ class and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). Reactions reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
Table 4 Adverse reactions in allergic asthma and CRSwNP
Infections and infestations
Uncommon
Rare
Pharyngitis
Parasitic infection
Blood and lymphatic system disorders
Not known
Idiopathic thrombocytopenia, including severe cases
Immune system disorders
Rare
Not known
Anaphylactic reaction, other serious allergic conditions, anti-omalizumab antibody development
Serum sickness, may include fever and lymphadenopathy
Nervous system disorders
Common
Uncommon
Headache*
Syncope, paraesthesia, somnolence, dizziness#
Vascular disorders
Uncommon
Postural hypotension, flushing
Respiratory, thoracic and mediastinal disorders
Uncommon
Rare
Not known
Allergic bronchospasm, coughing
Laryngoedema
Allergic granulomatous vasculitis (i.e. Churg-Strauss syndrome)
Gastrointestinal disorders
Common
Uncommon
Abdominal pain upper**,#
Dyspeptic signs and symptoms, diarrhoea, nausea
Skin and subcutaneous tissue disorders
Uncommon
Rare
Not known
Photosensitivity, urticaria, rash, pruritus
Angioedema
Alopecia
Musculoskeletal and connective tissue disorders
Common
Rare
Not known
Arthralgia†
Systemic lupus erythematosus (SLE)
Myalgia, joint swelling
General disorders and administration site conditions
Very common
Common
Uncommon
Pyrexia**
Injection site reactions such as swelling, erythema, pain, pruritus
Influenza-like illness, swelling arms, weight increase, fatigue
*: Very common in children 6 to < 12 years of age
**: In children 6 to < 12 years of age
#: Common in nasal polyp trials
†: Unknown in allergic asthma trials
Chronic spontaneous urticaria (CSU)
Summary of the safety profile
The safety and tolerability of omalizumab were investigated with doses of 75 mg, 150 mg and 300 mg every four weeks in 975 CSU patients, 242 of whom received placebo. Overall, 733 patients were treated with omalizumab for up to 12 weeks and 490 patients for up to 24 weeks. Of those, 412 patients were treated for up to 12 weeks and 333 patients were treated for up to 24 weeks at the 300 mg dose.
Tabulated list of adverse reactions
A separate table (Table 5) shows the adverse reactions for the CSU indication resulting from differences in dosages and treatment populations (with significantly different risk factors, comorbidities, co-medications and ages [e.g. asthma trials included children from 6 – 12 years of age]).
Table 5 lists the adverse reactions (events occurring in ≥ 1 % of patients in any treatment group and ≥ 2 % more frequently in any omalizumab treatment group than with placebo (after medical review)) reported with 300 mg in the three pooled phase III studies. The adverse reactions presented are divided into two groups: those identified in the 12‑week and the 24‑week treatment periods.
The adverse reactions are listed by MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions listed first. The corresponding frequency category for each adverse reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Table 5 Adverse reactions from the pooled CSU safety database (day 1 to week 24) at 300 mg omalizumab
12‑Week
Omalizumab studies 1, 2 and 3 Pooled
Frequency category
Placebo N = 242
300 mg N = 412
Infections and infestations
Sinusitis
5 (2.1 %)
20 (4.9 %)
Common
Nervous system disorders
Headache
7 (2.9 %)
25 (6.1 %)
Common
Musculoskeletal and connective tissue disorders
Arthralgia
1 (0.4 %)
12 (2.9 %)
Common
General disorder and administration site conditions
Injection site reaction*
2 (0.8 %)
11 (2.7 %)
Common
24‑Week
Omalizumab studies 1 and 3 Pooled
Frequency category
Placebo N = 163
300 mg N = 333
Infections and infestations
Upper respiratory tract infection
5 (3.1 %)
19 (5.7 %)
Common
* Despite not showing a 2 % difference to placebo, injection site reactions were included as all cases were assessed causally related to study treatment.
In a 48‑week study, 81 CSU patients received omalizumab 300 mg every 4 weeks (see section 5.1). The safety profile of long-term use was similar to the safety profile observed in 24‑week studies in CSU.
Description of selected adverse reactions
Immune system disorders
For further information, see section 4.4.
Anaphylaxis
Anaphylactic reactions were rare in clinical trials. However, post-marketing data following a cumulative search in the safety database retrieved a total of 898 anaphylaxis cases. Based on an estimated exposure of 566,923 patient treatment years, this results in a reporting rate of approximately 0.20 %.
Arterial thromboembolic events (ATE)
In controlled clinical trials and during interim analyses of an observational study, a numerical imbalance of ATE was observed. The definition of the composite endpoint ATE included stroke, transient ischaemic attack, myocardial infarction, unstable angina, and cardiovascular death (including death from unknown cause). In the final analysis of the observational study, the rate of ATE per 1,000 patient years was 7.52 (115/15,286 patient years) for omalizumab-treated patients and 5.12 (51/9,963 patient years) for control patients. In a multivariate analysis controlling for available baseline cardiovascular risk factors, the hazard ratio was 1.32 (95 % confidence interval 0.91–1.91). In a separate analysis of pooled clinical trials, which included all randomised double-blind, placebo-controlled clinical trials lasting 8 or more weeks, the rate of ATE per 1,000 patient years was 2.69 (5/1,856 patient years) for omalizumab-treated patients and 2.38 (4/1,680 patient years) for placebo patients (rate ratio 1.13, 95 % confidence interval 0.24–5.71).
Platelets
In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range. Isolated cases of idiopathic thrombocytopenia, including severe cases, have been reported in the post-marketing setting.
Parasitic infections
In allergic patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant. The course, severity, and response to treatment of infections were unaltered (see section 4.4).
Systemic lupus erythematosus
Clinical trial and post-marketing cases of systemic lupus erythematosus (SLE) have been reported in patients with moderate to severe asthma and CSU. The pathogenesis of SLE is not well understood.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
Maximum tolerated dose of Omlyclo has not been determined. Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20‑week period and this dose did not result in any untoward acute effects.
If an overdose is suspected, the patient should be monitored for any abnormal signs or symptoms. Medical treatment should be sought and instituted appropriately.
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