Xolair ® 75 mg/0,5 ml/150 mg/1,0 ml Solution

What XOLAIR is: 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.

XOLAIR ® solution for injection in pre-filled syringe or pre-filled pen: Each pre-filled syringe of 0.5 mL contains 75 mg of omalizumab. Each pre-filled syringe of 1 mL contains 150 mg of omalizumab.

What XOLAIR is used for: Allergic Asthma XOLAIR is indicated for the prevention of asthma exacerbations and control of asthma symptoms, when given as add-on therapy for 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): XOLAIR is indicated as add-on therapy to reduce the dose of inhaled corticosteroids 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.

XOLAIR treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. XOLAIR works by blocking a substance called immunoglobulin E (IgE) which is produced by your body. IgE plays a key role in causing allergic asthma.

Chronic Spontaneous Urticaria (CSU) XOLAIR is used to treat Chronic Spontaneous Urticaria in adults and adolescents (12 years of age and older) whose CSU symptoms are not well controlled by the medicines usually used to treat the condition, such as antihistamines and leukotriene receptor antagonists (LTRAs). XOLAIR works by blocking a substance called immunoglobulin E (also known simply as IgE) which is produced by your body. As a consequence the activity of specific receptors and/or cells in your body which play a key role in causing chronic spontaneous urticaria are reduced. This leads to a reduction of your symptoms, like itching and hives.

Nasal Polyps: This medicine is used to treat 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. XOLAIR 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. Xolair 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 nasal polyps.

Do not use XOLAIR:

• If you are allergic to any of the ingredients in XOLAIR. The ingredients are listed at the beginning of this leaflet.
• If you think you may be allergic to any of the ingredients, tell your doctor since you should not be given XOLAIR.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• 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 live in a region where infections caused by parasites are common or if you are travelling to such a region as XOLAIR may weaken your resistance to such infections;
• if you have ever had an allergic reaction to latex. The needle cap of the syringe may contain dry rubber (latex).

XOLAIR contains a protein, and proteins can cause serious allergic reactions in some people.

Signs include rash, difficulty in breathing, swelling or feeling faint. If you have an allergic reaction after taking XOLAIR, contact a doctor as soon as you can.

XOLAIR 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, allergic skin rash or hay fever.

Allergic Asthma

You should not receive XOLAIR to treat acute asthma symptoms, like a sudden asthma attack.

You will have been given a separate medicine for this.

Children (under 6 years of age):

Allergic Asthma

Do not give XOLAIR to children under 6 years of age. There are not enough data in this group.

Chronic Spontaneous Urticaria

Do not give XOLAIR to children under 12. Its use in children below 12 years of age has not been studied sufficiently.

Other medicines and XOLAIR

Always tell your health care provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following medicines:

• Medicines to treat an infection caused by a parasite, as XOLAIR may reduce the effect of your medicines.
• Although XOLAIR can be used together with inhaled corticosteroids and other medicines for allergic asthma as well as with H1 or H2 antihistamines and LTRAs for chronic spontaneous urticaria, it is still important to tell your doctor that you are taking these medicines.

Pregnancy, breastfeeding and fertility

Pregnancy

• If you are pregnant or breastfeeding your baby while using this medicine, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.
• You should not use XOLAIR when you are pregnant.
• If you plan to become pregnant, tell your doctor before starting treatment with XOLAIR.
• Your doctor will discuss with you the benefits and potential risks of being given this medicine during pregnancy.
• If you become pregnant while being treated with XOLAIR, tell your doctor immediately.

Breastfeeding

You should not use XOLAIR when you are breastfeeding.

Driving and using machinery

XOLAIR may make you feel sleepy, faint or dizzy and affect your mental and/or physical abilities to perform or execute tasks or activities requiring mental alertness, judgment and/or sound coordination and vision e.g. driving, riding, flying, sailing, operating machines/equipment (see 4 Possible side effects). If this happens to you do not drive or use machines.

Do not share medicines prescribed for you with any other person.

Always use XOLAIR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is: XOLAIR is given to you by a doctor or nurse as an injection just under the skin.

Allergic Asthma

Your doctor will work out how much XOLAIR you need and how often you will be given it.

This depends on your body weight and the results of a blood test carried out before start of the treatment to measure the amount of IgE in your blood.

Follow carefully all instructions given by your doctor or nurse.

How much you will be given

Allergic Asthma

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

Carry on taking your current asthma medicine during XOLAIR treatment.

Do not stop taking any asthma medicines without talking to your doctor.

You may not see an immediate improvement in your asthma after beginning XOLAIR therapy.

It usually takes several weeks to have the full effect.

Chronic Spontaneous Urticaria

You will be given 1 or 2 injections at a time every four weeks.

Continue taking your current medicine for CSU during XOLAIR treatment.

Do not stop taking any medicine without talking to your doctor first.

Nasal Polyps

Your doctor will decide how much XOLAIR 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 nasal polyps medicine during XOLAIR treatment.

Do not stop taking any nasal polyps medicine without talking to your doctor.

You may not see an immediate improvement after beginning XOLAIR treatment.

In patients with nasal polyps effects have been seen 4 weeks after the start of the treatment.

Use in children and adolescents

Nasal Polyps

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

Injecting XOLAIR pre-filled syringe:

You and your doctor will decide if you should inject XOLAIR yourself.

The first 3 doses are always given by or under the supervision of a healthcare professional.

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 XOLAIR injection after he or she has received proper training.

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

Your doctor will tell you how long your treatment with XOLAIR will last. If you have the impression that the effect of XOLAIR is too strong or too weak, tell your doctor or pharmacist.

If you use more XOLAIR than you should

Since a healthcare professional will administer XOLAIR, he/she will control the dosage.

In the event of overdosage, consult your doctor or pharmacist.

If neither is available, contact the nearest hospital or poison control centre.

If you missed a dose of XOLAIR

Contact your doctor or hospital as soon as possible to re-schedule your appointment. Do not use a double dose to make up for forgotten individual doses.

If you stop using XOLAIR

Interrupting or stopping the treatment with XOLAIR may cause your asthma or CSU symptoms or nasal polyps to come back.

XOLAIR can have side effects. Some side effects can be serious. Not all side effects reported for XOLAIR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, stop taking XOLAIR and tell your doctor immediately or go to the casualty department at your nearest hospital: Serious side effects include:

Less Frequent side effects

Sudden severe allergic reactions: If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heartbeat, dizziness and light headedness, shortness of breath, wheezing or trouble breathing, or any other new symptoms, tell your doctor or nurse immediately. If you have a history of severe allergic reactions (anaphylaxis) unrelated to XOLAIR, you may be more at risk of developing a severe allergic reaction following XOLAIR administration.

Weakness or paralyses of limbs or face, loss of sensation, difficulty speaking or understanding, transient loss of vision of one eye, could be symptoms of a transient ischemic attack or stroke. Seek immediate medical attention if you experience any such symptoms. If you experience any of these, tell your doctor or nurse straight away. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to XOLAIR. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following: The following side effects have been reported frequently:

• fever (in children);
• reactions at the injection site including pain, swelling, itching and redness;
• pain in the upper part of the abdomen (in children);
• headache (very common in children);
• sore throat and blocked nose (nasopharyngitis);
• feeling of pressure or pain in the cheeks and forehead (sinusitis and sinus headache);
• upper respiratory tract infection, such as inflammation of the pharynx and common cold;
• burning sensation or pain when passing urine and having to urinate frequently (possible symptom of a urinary tract infection);
• pain in upper or lower limbs (arms and/or legs);
• pain in muscles and/or bones and/or joints (musculoskeletal pain, myalgia, arthralgia).

The following side effects have been reported less frequently:

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

The following side effects have been reported but the frequency is unknown:

• development of any combination of the following symptoms: pain, numbness, tingling in arms and legs, lumps or raised patches in the skin, worsening problems with breathing, nasal congestion (signs of so-called “Churg-Strauss syndrome”);
• low blood platelet count with symptoms such as bleeding or bruising more easily than normal;
• development of any of the following symptoms, especially if in combination: joint pain with or without swelling, rash, fever, swollen lymph nodes, muscle pain (signs of serum sickness).

If any of these side effects gets serious, or if you notice any side effect not mentioned in this leaflet please tell your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of XOLAIR.

Store all medicines out of reach of children.

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 20 minutes).

Leave the syringe in the box to protect it from light.

The time that the syringe is kept at room temperature (25 °C) before use must not exceed 2 days (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.

Do not store in a bathroom.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Return all unused medicine to your pharmacist.