Xolair (omalizumab)

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 an add-on treatment for severe asthma that occurs as a result of allergies.

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

An allergy develops when the immune system over-reacts to an allergen such as pet fur and produces antibodies to attack it. These anti-allergen antibodies are known as immunoglobulin E antibodies (IgE for short). They stay in the body and recognise future encounters with the allergen. Each time you encounter the allergen, the IgE antibodies bind to it and then bind to the surface of allergy cells called basophils. This triggers these cells to release various chemicals, including histamine, that cause the symptoms of an allergic reaction. In allergic asthma, these chemicals cause inflammation and narrowing of the airways and ultimately an asthma attack.

Omalizumab is a manufactured antibody. It has been designed to specifically recognise and bind to the IgE antibodies that your body produces as a result of your allergy. This stops your IgE from binding to the allergens that would normally cause your asthma. Ultimately this prevents the IgE and allergen from triggering the basophils to release their allergy chemicals.

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

This medicine is used to improve asthma control in adult and adolescent patients (12 years of age and above) who have severe, persistent allergic asthma. This means very reduced lung function as a result of the allergy, with frequent daytime symptoms or night-time awakenings and many severe asthma attacks, despite treatment with daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta 2 agonist such as salmeterol.

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

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

What is it used for?

Severe, persistant allergic asthma.

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.

This medicine will not work to treat an acute asthma attack. You will normally need to keep taking your other asthma medicines during treatment with this one 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 allergy, 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, after receiving this injection.

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.

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.

Diabetes.

Glucose-galactose malabsorption syndrome, fructose intolerance or sucrase-isomaltase deficiency.

Not to be used in

Allergy to any ingredient.

The manufacturer has not tested the safety and efficacy of this medicine in children under 12 years of age and it is therefore not recommended for this age group.

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

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

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, 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. 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 individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

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

Headache.

Sleepiness.

Pins and needles sensations.

Dizziness.

Fainting.

A drop in blood pressure that occurs when going from lying down to sitting or standing, causing dizziness and lightheadedness (postural hypotension).

Flushing.

Coughing.

Inflammation of the throat (pharyngitis).

Nausea.

Diarrhoea.

Indigestion.

Rash or itching.

Abnormal reaction of the skin to light, usually a rash (photosensitivity).

Weight gain.

Fatigue.

Swollen arms.

Flu-like illness.

Allergic reactions such as narrowing of the airways (allergic bronchospasm).

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

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

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