Patient leaflet - Adcomfo 75 mg solution for injection in Pre-filled syringe
1. What ADCOMFO is and what it is used for
ADCOMFO 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.
ADCOMFO is used for the treatment of:
- allergic asthma
- chronic rhinosinusitis (inflammation of the nose and sinuses) with nasal polyps
Allergic asthma
This medicine is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults, adolescents and children (6 years of age and older) who are already receiving asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers and beta-agonist inhalers.
Chronic rhinosinusitis with nasal polyps
This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (18 years of age and older) who are already receiving intranasal corticosteroids (corticosteroid nasal spray), but whose symptoms are not well controlled by these medicines. Nasal polyps are small growths on the lining of the nose. ADCOMFO 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.
ADCOMFO works by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and chronic rhinosinusitis with nasal polyps.
2. What you need to know before you use ADCOMFO
Do not use ADCOMFO:
if you are allergic to omalizumab or any of the other ingredients of this medicine
(listed in section 6).
If you think you may be allergic to any of the ingredients, tell your doctor as you should not use ADCOMFO.
Warnings and precautions
Talk to your doctor before using ADCOMFO:
- 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
- ADCOMFO 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.
ADCOMFO does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore ADCOMFO should not be used to treat such symptoms. ADCOMFO is not meant to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungus-related lung disease), food allergy, eczema or hay fever because ADCOMFO has not been studied in these conditions.
Look out for signs of allergic reactions and other serious side effects
ADCOMFO can potentially cause serious side effects. You must look out for signs of these conditions while you use ADCOMFO. 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 ADCOMFO yourself or before a non-healthcare professional gives you a ADCOMFO injection (see section 3, “How to use ADCOMFO”). The majority of severe allergic reactions occur within the first 3 doses of ADCOMFO.
Children and adolescents
Allergic asthma
ADCOMFO 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
ADCOMFO is not recommended for children and adolescents under 18 years of age. Its use in patients under 18 years of age has not been studied.
Other medicines and ADCOMFO
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 ADCOMFO 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 ADCOMFO, tell your doctor immediately.
ADCOMFO 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 ADCOMFO will affect your ability to drive and use machines.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free’.
3. How to use ADCOMFO
Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.
How ADCOMFO is used
ADCOMFO is used as an injection under your skin (known as a subcutaneous injection).
Injecting ADCOMFO
You and your doctor will decide if you should inject ADCOMFO 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 ADCOMFO injection
after he or she has received proper training.
For detailed instructions on how to inject ADCOMFO, see “Instructions for use of ADCOMFO pre-filled syringe” at the end of this leaflet.
Training to recognise serious allergic reactions
It is also important that you do not inject ADCOMFO yourself until you have been trained by your doctor or nurse on:
- how to recognise the early signs and symptoms of serious allergic reactions.
- what to do if the symptoms occur.
For more information about the early signs and symptoms of serious allergic reactions, see section 4.
How much to use
Your doctor will decide how much ADCOMFO 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 ADCOMFO 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 ADCOMFO treatment. In patients with nasal polyps effects have been seen 4 weeks after the start of the treatment. In asthma patients it usually takes between 12 and 16 weeks to have the full effect.
Use in children and adolescents
Allergic asthma
ADCOMFO 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 ADCOMFO 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) are not expected to self-administer ADCOMFO. However, if considered appropriate by their doctor, a caregiver may give them their ADCOMFO injection after proper training.
Chronic rhinosinusitis with nasal polyps
ADCOMFO should not be used in children and adolescents under 18 years of age.
If a dose of ADCOMFO 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 ADCOMFO, 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 ADCOMFO
Do not stop treatment with ADCOMFO unless your doctor tells you to. Interrupting or stopping the treatment with ADCOMFO may cause your symptoms to come back. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by ADCOMFO 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 1,000 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 ADCOMFO you may be more at risk of developing a severe allergic reaction following use of ADCOMFO.
- Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss, and fatigue.
Not known: frequency cannot be estimated from the available data
- Churg-Strauss syndrome or hypereosinophilic syndrome. Symptoms may include one or more of the following: swelling, pain or rash around blood or lymph vessels, high level of a specific type of white blood cells (marked eosinophilia), worsening problems with breathing, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs.
- Low blood platelet count with symptoms such as bleeding or bruising more easily than normal.
- Serum sickness. Symptoms may include one or more of the following: joint pain with or without swelling or stiffness, rash, fever, swollen lymph nodes, muscle pain.
Other side effects include:
Very common: may affect more than 1 in 10 people
- fever (in children)
Common: may affect up to 1 in 10 people
- reactions at the injection site including pain, swelling, itching and redness
- pain in the upper part of the tummy
- headache (very common in children)
- feeling dizzy
- pain in joints (arthralgia)
Uncommon: may affect up to 1 in 100 people
- feeling sleepy or tired
- tingling or numbness of the hands or feet
- fainting, low blood pressure while sitting or standing (postural hypotension), flushing
ADCOMFO® 75 mg solution for injection in pre-filled syringe
omalizumab
ADCOMFO® 75 mg solution for injection in pre-filled syringe
omalizumab
INSTRUCTIONS FOR USE
ADCOMFO Injection, for subcutaneous use
Pre-filled Syringe
Read all the way through these instructions before injecting. If your doctor decides that you or a caregiver may be able to give your injections of ADCOMFO at home, you need to be trained by your doctor, nurse, or pharmacist before you inject yourself or others. Children (6 to less than 12 years of age) are not expected to inject ADCOMFO themselves, however, if deemed appropriate by their doctor, a caregiver may give them their ADCOMFO injection after proper training. The box contains ADCOMFO pre-filled syringe(s) individually sealed in a plastic tray.
After the medicine has been injected, the syringe guard will be activated to cover the needle. This is intended to protect against accidental needlestick injuries.
Other items you need for your injection:
- Alcohol swab.
- Cotton ball or gauze.
Sharps disposal container
Important safety information
Caution: Keep the syringe out of the sight and reach of children.
- Do not open the sealed outer box until you are ready to use this medicine.
Do not use this medicine if either the seal on the outer box or the seal of the
plastic tray is broken, as it may not be safe for you to use.
Do not use if the syringe has been dropped onto a hard surface or dropped after
removing the needle cap.
- Never leave the syringe where others might tamper with it.
- Do not shake the syringe.
Be careful not to touch the syringe guard wings before use. If the wings are
touched, the syringe guard may be activated too early.
- Do not remove the needle cap until just before you give the injection.
The syringe cannot be re-used. Dispose of the used syringe immediately after use
in a sharp’s container.
Storage of ADCOMFO solution for injection in pre-filled syringe
Store this medicine sealed in its outer box to protect it from light. Store in the
refrigerator between 2°C and 8°C. DO NOT FREEZE.
Remember to take the syringe out of the refrigerator and allow it to reach room
temperature (25°C) before preparing it for injection (it will take about 30 minutes).
Leave the syringe in the box to protect it from light. The total time that the syringe is kept at room temperature (25°C) before use must not exceed 48 hours.
Do not use the syringe after the expiry date which is stated on the outer box and
syringe label. If it has expired, return the entire pack to the pharmacy.
Preparing ADCOMFO solution for injection in pre-filled syringe for use
Note: Depending on the dose prescribed to you by your doctor, you may need to prepare one or more pre-filled syringes, and inject the contents of them all. The following table gives examples of how many injections of each dose strength you need for a given dose:
- 1.
Take the box containing the syringe out of the refrigerator and leave it unopened
for about 30 minutes so that it reaches room temperature (leave the syringe in the box to protect it from light).
- 2.
When you are ready to use the syringe, wash your hands thoroughly with soap
and water.
- 3. Clean the injection site with an alcohol swab.
- 4.
Remove the plastic tray from the box and peel back the paper cover. Gripping the
middle of the syringe guard, lift the syringe out of the tray.
- 5. Inspect the syringe. The liquid should be clear to slightly cloudy. Its colour may vary from colourless to pale brownish-yellow. You may see an air bubble, which is normal. DO NOT USE if the syringe is broken or if the liquid looks distinctly cloudy or distinctly brown, or contains particles. In all these cases, return the entire pack to the pharmacy.
- 6. Holding the syringe horizontally, look into the viewing window to check the expiry date printed on the label. Note: It is possible to rotate the inner part of the syringe assembly so that the label can be read in the viewing window. DO NOT USE if the product has expired. If expired, return the entire pack to the pharmacy.
The injection site
The injection site is the place on the body where you are going to use the syringe. • The recommended site is the front of the thighs. You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button). • If you need to give more than one injection for the full dose, choose a different injection site each time you inject.
- Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks.
If a caregiver is giving the injection, the outer upper arms may also be used.
Pre-Filled Syringe 75 mg/mL
800mm
120mm
45°
- 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 1,000 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 Yellow Card Scheme Website: 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 ADCOMFO
- 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 48 hours 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 ADCOMFO contains
The active substance is omalizumab. One syringe of 0.5 mL solution contains 75 mg
omalizumab.
The other ingredients are arginine hydrochloride, sodium phosphate dibasic heptahydrate,
sodium phosphate monobasic monohydrate, poloxamer 188 and water for injections.
What ADCOMFO looks like and contents of the pack
ADCOMFO solution for injection is supplied as a clear to slightly opalescent, colourless to pale brownish-yellow solution in a pre-filled syringe.
ADCOMFO 75 mg solution for injection in pre-filled syringe with 27-gauge staked needle and plunger is available in packs containing 1 pre-filled syringe and in multipacks containing 3 (3 x 1) or 6 (6 x 1) pre-filled syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
Manufacturer
Alvotech Hf
Sæmundargata 15-19
Reykjavik, 102
Iceland
This leaflet was last revised in 01/2026.
AW-LF-0001572 (v0.5)
How to use ADCOMFO solution for injection in pre-filled syringe
Carefully remove the needle cap from the syringe. Discard the needle cap. You may see a drop of liquid at the end of the needle. This is normal.
Gently pinch the skin at the injection site and insert the needle as shown. Push the needle all the way in to ensure that the medicine can be fully administered.
Hold the syringe as shown. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.
Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 30 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
Disposal instructions
Dispose of the used syringe immediately in a sharp’s container (closable, puncture resistant container). For the safety and health of you and others, needles and used syringes must never be re-used. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Pre-Filled Syringe 75 mg/mL
800mm