How does it work?

Xolair injection contains the active ingredient omalizumab,which is a type of medicine called a monoclonal antibody. It is used as anadd-on treatment for severe asthma that occurs as a result ofallergies.

Allergic asthma occurs when the lungs are exposed to allergensthat the body is over-sensitised or allergic to. Allergens include substancessuch as pollen, pet fur and house dust mites.

Anallergy develops when the immune system over-reacts toan allergen such as pet fur and produces antibodies to attack it. Theseanti-allergen antibodies are known as immunoglobulin E antibodies (IgE forshort). They stay in the body and recognise future encounters with theallergen. Each time you encounter the allergen, the IgE antibodies bind to itand then bind to the surface of allergy cells called basophils. This triggersthese cells to release various chemicals, including histamine, that cause thesymptoms of an allergic reaction. In allergic asthma, these chemicals causeinflammation and narrowing of the airways and ultimately an asthma attack.

Omalizumab is a manufactured antibody. It has been designed tospecifically recognise and bind to the IgE antibodies that your body producesas a result of your allergy. This stops your IgE from binding to the allergensthat would normally cause your asthma. Ultimately this prevents the IgE andallergen from triggering the basophils to release their allergychemicals.

Omalizumab therefore works by preventing your body from reactingto allergens that would normally give you an asthma attack.

Your doctor will measure the amount of IgE in your blood beforegiving you Xolair injections. This is so they can work our how much medicine isneeded to neutralise your IgE. The injection is given under the skin, usuallyof the arm. You may need between one and three injections every two to fourweeks, depending on your IgE level and body weight.

You may not see an immediate improvement in your asthma afterbeginning Xolair treatment. It usually takes several weeks to have the fulleffect. You should be aware that the medicine is not a permanent cure for theallergy and if the treatment is stopped or interrupted it may cause your asthmasymptoms to come back.

What is it used for?

• Severe, persistant allergic asthma.

This medicine is used to improve asthma control in adults andchildren aged six years and above who have severe, persistentallergic asthma. This means very reduced lung function as a result of theallergy, with frequent daytime symptoms or night-time awakenings and manysevere asthma attacks, despite treatment with daily high-dose inhaledcorticosteroids, plus a long-acting inhaled beta 2 agonist such as salmeterol.

Warning!

• If you feel dizzy, faint or drowsy after having this injection you should avoid performing potentially hazardous activities such as driving or operating machinary until you feel better.
• This medicine will not work to treat an acute asthma attack. You will normally need to keep taking your other asthma medicines while you are having these injections, and you should make sure you still keep your reliever inhaler with you at all times in case you have an asthma attack.
• If you find that your asthma is improved after receiving treatment with this medicine you should not suddenly stop taking any of your other medicines, in particular any corticosteroid inhalers or tablets, without first consulting your doctor. Corticosteroids should only be stopped on the advice of your doctor and may sometimes need to be stopped gradually.
• Despite being used to treat allergic asthma, this medicine can itself on rare occasions cause allergic reactions. You should tell your doctor immediately if you get any sudden signs of allergic reactions after having this injection, such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, shortness of breath or trouble breathing.

Use with caution in

• Decreased kidney function.
• Decreased liver function.
• Diseases caused by the immune system attacking the body's own tissues (autoimmune diseases).
• Conditions caused by antibody-antigen complexes.
• People at risk of parasitic worm infections, for example people living in or travelling to areas where these infections are common. (This medicine may weaken your resistance to these infections, and could make treatments for them less effective. Ask your doctor for advice if this applies to you.)
• Diabetes (Xolair injections contain sucrose).
• Glucose-galactose malabsorption syndrome, fructose intolerance or sucrase-isomaltase deficiency (Xolair injections contain sucrose).

Not to be used in

• Allergy to any ingredient.
• Breastfeeding.
• The manufacturer has not tested the safety and efficacy of this medicine in children under six years of age and it is therefore not recommended for this age group.
• Xolair should not be used to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), allergic bronchopulmonary aspergillosis (a fungus-related lung disease), food allergy, allergic skin rash or hay fever, as it has not been studied in these conditions.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine during pregnancy has not been established. It is not recommended for use in pregnant women unless considered essential by your doctor. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It should not be given to women who are breastfeeding. Mothers who need this medicine should not breastfeed their infants while receiving the therapy. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience thator any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Reactions at the injection site, such as pain, redness, itching, swelling.
• Headache.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Sleepiness.
• Pins and needles sensations.
• Dizziness.
• Fainting.
• Nausea.
• Diarrhoea.
• Indigestion.
• Rash, hives or itching.
• Abnormal reaction of the skin to light, usually a rash (photosensitivity).
• Inflammation of the throat (pharyngitis).
• Coughing.
• Allergic reactions such as narrowing of the airways (allergic bronchospasm).
• A drop in blood pressure that occurs when going from lying down to sitting or standing, causing dizziness and lightheadedness (postural hypotension).
• Flushing.
• Weight gain.
• Fatigue.
• Swollen arms.
• Flu-like illness.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Anaphylactic reaction or other severe allergic reactions.
• Severe swelling of the lips, throat and tongue (angioedema).
• Parasitic infections.

Frequency not known

• Severe drop in the number of blood cells called platelets in the blood (idiopathic thrombocytopenia). Tell your doctor if you experience any unusal bruising or bleeding while having these injections.
• Allergic syndrome called Churg-Strauss syndrome. Tell your doctor if you get any combination of the following symptoms while having these injections: pain, numbness or tingling in the arms and legs, lumps or raised patches in the skin, worsening problems with breathing, nasal congestion.
• Serum sickness, which is a delayed allergic reaction. Tell your doctor if you experience any of the following symptoms after having this injection, particularly if you get more than one: joint pain with or without swelling, rash, fever, swollen lymph glands and muscle pain.
• Hair loss.
• Aching muscles or joints.
• Joint swelling.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you arealready taking, including those bought without a prescription and herbalmedicines, before you start treatment with this medicine. Similarly, check withyour doctor or pharmacist before taking any new medicines while havingtreatment with this one, to make sure that thecombination is safe.

Xolair injections may reduce the effectiveness of medicines to treat parasitic worm infections. Tell your doctor if you are taking medicine to treat a worm infection.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain omalizumab as the active ingredient.