Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
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.
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 0.80 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.
You will need 1 to 3 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 one 300 mg injection at a time 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 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. 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 reschedule 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.
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.
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 – 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.
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 03/2026
INSTRUCTIONS FOR USE OF OMLYCLO PRE-FILLED PEN
Read and follow the Instructions for Use that come with your Omlyclo pre-filled pen before you start using it and each time you get a refill. There may be new information. Before you use Omlyclo, make sure your healthcare provider shows you the right way to use it.
Adolescents 12 years of age and older: Omlyclo pre-filled pen may be self-administered under adult supervision. The Omlyclo pre-filled pen (all doses) are intended for use only in adults and adolescents aged 12 years and older.
Pre-filled Pen Parts (see Figure A)
Choose the Correct Pre-filled Pen or Combination of Pre-filled Pens
Omlyclo pre-filled pens are available in 3 dose strengths (see Figure B).
Your prescribed dose may require more than 1 injection. The Dosing Table (Figure C) to the below shows the combination of pre-filled pens needed to give your full dose. Check the label on the
Figure A
Figure B
Omlyclo carton to make sure you have received the correct pre-filled pen or combination of pre-filled pens 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 Dosing Table
Note: Your healthcare provider may prescribe a different combination of pre-filled pens for your complete dose. Important information you need to know before injecting Omlyclo
• Omlyclo is for subcutaneous injection only (inject directly into fatty layer under the skin). • Do not use if the carton is damaged or appears to be tampered with. • Do not open the carton until you are ready to inject. • Do not use the pre-filled pen if it has been damaged or appears to be tampered with. • Do not remove the cap until you are ready to inject Omlyclo. • Do not use if the pre-filled pen has been dropped on a hard surface or dropped after removing the cap. • Do not try to take apart the pre-filled pen at any time. • Do not clean or touch the needle cover. How Should I Store Omlyclo?
Figure C
• Store the unused pre-filled pen in the original carton in a refrigerator between 2°C to 8ºC. • 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 Omlyclo is exposed to temperatures above 25°C, do not use Omlyclo and throw it away in a sharps disposal container. • Do not remove the pre-filled pen from its original carton during storage. • Keep the pre-filled pen out of direct sunlight. • Do not freeze. Do not use if the pre-filled pen has been frozen. • Keep the pre-filled pen, sharps disposal container, and all medicines out of sight and the reach of children. Contains small parts.
Preparing for the Injection
Figure D
Figure E
Figure F
1. Take the carton containing the Pre-filled Pen out of the refrigerator and allow the Pre-filled Pen to reach room temperature.
1.a. If you need more than 1 pre-filled pen to deliver your prescribed dose (see Figure C), take all the cartons out of the refrigerator at the same time (each carton contains 1 prefilled pen). The following steps must be followed for each pre-filled pen.
1.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 pen in the carton to protect it from light (see Figure D).
⚫ Do not warm the pre-filled pen using heat sources such as hot water or a microwave.
⚫ If the pre-filled pen does not reach room temperature, this could cause discomfort.
2. Gather the supplies needed to give your injection (see Figure E).
- Carton containing Omlyclo pre-filled pen Not included in the carton: - Alcohol swab - Cotton ball or gauze - Adhesive bandage - Sharps disposal container Note: You may need more than 1 Omlyclo prefilled pen for your prescribed dose. See the Dosing Table (Figure C) for more information. Each Omlyclo carton contains 1 pre-filled pen.
3. Check the expiration on the carton (see Figure F).
⚫ Do not use the pre-filled pen if the expiration date has passed.
⚫ If the expiration date has passed, throw away the pre-filled pen in a sharps disposal container (see step 16) and contact your healthcare provider.
Figure G
Figure H
4. Open the carton.
4.a. Wash your hands with soap and water.
4.b. Take the pre-filled pen out of the carton by holding it from the middle (see Figure G).
⚫ Do not turn the carton upside down to take out the pre-filled pen as this may damage it.
⚫ Do not hold the pre-filled pen by the cap.
⚫ Do not remove the cap until you are ready to inject.
5. Check the pre-filled pen. 5.a. Look through the viewing window of the prefilled pen to check that the liquid is clear to slightly cloudy, colourless to pale brownishyellow, and free of particles or flakes. You may notice air bubbles in the medicine, which is normal (see Figure H).
⚫ Do not use the pre-filled pen if the liquid is discoloured, distinctly cloudy, or has particles or flakes in it. 5.b. Check the expiration date on the pre-filled pen.
⚫ Do not use the pre-filled pen if the expiration date has passed. 5.c. Check the pre-filled pen for signs of damage or if it appears to be tampered with.
⚫ Do not use the pre-filled pen if it appears to be damaged or tampered with. 5.d. If the medicine does not look as described or if the expiration date has passed, safely dispose of the pre-filled pen in a sharps disposal container (see Step 16) and contact your healthcare provider.
Figure I
Figure J
6. Choose an injection site (see Figure I) 6.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). 6.b. If a caregiver or healthcare provider (HCP) is giving the injection, they can use:
- 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).
⚫ Do not inject into the upper arm by yourself.
⚫ 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.
⚫ If your prescribed dose requires more than 1 injection, make sure your injection site are at least 2 cm apart from each other.
7. Clean the injection site. 7.a. Wipe the injection site with an alcohol swab in a circular motion and let it air dry for 10 seconds (see Figure J)
⚫ Do not touch the injection site again before giving the injection.
⚫ Do not fan or blow on the clean area.
Giving the Injection
Figure K
Figure L
8. Remove the Cap. 8.a. Hold the pre-filled pen firmly with 1 hand and pull the cap straight off with the other hand (see Figure K)
⚫ Do not twist the cap.
⚫ Do not re-cap the pre-filled pen.
⚫ You may see a few drops of liquid at the tip of the needle. This is normal. 8.b. Throw away the cap in regular household trash.
⚫ Do not clean or touch the needle cover at the tip of the pre-filled pen.
9. Position the pre-filled pen. 9.a. Hold the pre-filled pen comfortably with the needle cover directly against the skin and position it so you can see the viewing window.
9.b. Without pinching or stretching the skin, place the pre-filled pen against the skin at a 90degree angle (see Figure L).
Figure M
Figure N
Figure O
10. Start the injection. 10.a. Press straight down and hold the pre-filled pen firmly against the skin. The 1st click indicates that the injection has started (see Figure M)
10.b. Hold the pre-filled pen tightly in place.
⚫ Do not change the angle of the injection or remove the pre-filled pen until the injection is completed.
11. Monitor the injection using the lavender indicator. 11.a. Keep holding the pre-filled pen against the skin. The lavender indicator will move within the viewing window (see Figure N).
12. Complete the injection. 12.a. Listen for the 2nd click. This indicates that the injection is almost complete (see Figure O).
12.b. After you hear the 2nd "click", continue to hold the pre-filled pen firmly against the skin and count slowly to 5 to make sure you inject the full dose (see Figure O).
12.c. Hold the pre-filled pen in position until the lavender indicator has stopped moving and completely fills the viewing window to make sure the injection is complete.
Figure P
14. Care for the injection site. 14.a. If a little 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. 14.b. In the case of skin contact with the medicine, wash the area that touched the medicine with water.
15. If your prescribed dose requires more than 1 injection: 15.a. Throw away the used pre-filled pen as described in Step 16 and Figure Q.
15.b. Repeat Step 2 through Step 14 for the next injection using a new pre-filled pen.
⚫ Complete all the required injections for your prescribed dose, immediately one after another. Contact your healthcare provider if you have any questions.
13. Remove the pre-filled pen from the skin and check the lavender indicator (see Figure P). 13.a. After the lavender indicator has stopped moving and has completely filled the viewing window, lift the pre-filled pen straight up from the skin. The needle cover will automatically extend and lock the needle.
⚫ If the lavender indicator has not completely filled the viewing window, contact your healthcare provider or pharmacist.
⚫ Choose a different injection site for each new injection at least 2 cm from other injection sites.
After the injection
Figure Q
⚫ properly labeled to warn of hazardous waste inside the container. Talk to your doctor or pharmacist about proper disposal of the sharps disposal container. There may be local regulations for disposal.
16. Throw away (dispose of) pre-filled pen. 16.a. Put the used pre-filled pen and other supplies in a sharps disposal container right away after use (see Figure Q).
⚫ Do not re-use the pre-filled pen.
⚫ Do not re-cap the pre-filled pen.
⚫ Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this.
⚫ Do not recycle your used sharps disposal container. If you do not have a sharps disposal container, you may use a household container that is:
⚫ made of a heavy-duty plastic,
⚫ can be closed with a tight-fitting,
⚫ puncture-resistant lid, without sharps being able to come out,
⚫ upright stable during use,
⚫ leak-resistant, and
Omlyclo 300 mg pre-filled pen comes as medicine containing 300 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Omlyclo 300 mg pre-filled pen is omalizumab.
Medicines with the same active substance include: Omlyclo 150 mg solution for injection in pre-filled syringe, Omlyclo 150mg solution for injection pre-filled pen, Omlyclo 300 mg/2 ml Solution for injection pre-filled syringe, Omlyclo 75 mg solution for injection in pre-filled syringe, Omlyclo 75mg solution for injection pre-filled pen, Xolair 150 mg solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Omlyclo 300 mg pre-filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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 pre-filled pens*, number of injections** and total injection volume for each administration
| Dose (mg) | Number of pens* | 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 |
*All dose strengths of Omlyclo pre-filled pen are 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 pen 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 one subcutaneous injection of 300 mg or 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.
All dose strengths of Omlyclo pre-filled pen 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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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.
Omalizumab has no or negligible influence on the ability to drive and use machines.
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.
Ask anything about Omlyclo 300 mg pre-filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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