Prospecto: information for the user

Xolair 75mg injectable solution in pre-filled syringe

(pre-filled syringe with fixed 26 gauge needle and blue syringe protector)

omalizumab

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

1.What Xolair is and for what it is used

2.What you need to know before starting to use Xolair

3.How to use Xolair

4.Possible adverse effects

5.Storage of Xolair

6.Contents of the package and additional information

Xolair contains the active substance omalizumab. Omalizumab is a human protein, similar to the natural proteins produced by the body. It belongs to a class of medications called monoclonal antibodies.

Xolair is used for the treatment of:

• allergic asthma
• chronic rhinosinusitis (inflammation of the nose and sinuses) with nasal polyps

Allergic Asthma

This medication is used to prevent asthma from worsening by controlling the symptoms of severe allergic asthma in adults, adolescents, and children (6 years of age and older) who are already receiving asthma medications, but whose symptoms are not adequately controlled with medications such as high-dose inhaled steroids and inhaled beta agonists.

Chronic Rhinosinusitis with Nasal Polyps

This medication is used to treat chronic rhinosinusitis with nasal polyps in adults (18 years of age and older) who are receiving intranasal corticosteroids (nasal powder with corticosteroids), but whose symptoms are not well controlled with these medications. Nasal polyps are small growths in 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, postnasal mucosity, and nasal discharge.

Xolair acts by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE is involved in a type of inflammation that plays a key role as a cause of allergic asthma and chronic rhinosinusitis with nasal polyps.

Do not use Xolair

-if you are allergic to omalizumab or any of the other components of this medication (listed in section6).

If you think you may be allergic to any of the components, inform your doctor as you should not use Xolair.

Warnings and precautions

Consult your doctor before using Xolair:

• if you have kidney or liver problems,
• if you have an autoimmune disorder, where your immune system attacks parts of your own body,
• if you are traveling to an area where parasitic infections are common, as Xolair may decrease your resistance to such infections,
• if you have had a severe allergic reaction (anaphylaxis) previously, for example as a result of taking a medicine, an insect bite, or food,
• if you have had an allergic reaction to latex. The cap of the syringe needle may contain dried latex.

Xolair does not treat acute asthma symptoms, such as a sudden asthma attack. Therefore, Xolair should not be used to treat this type of symptom.

Xolair is not intended to prevent or treat other allergic conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (hereditary immune disorder), aspergillosis (lung disease caused by a fungus), food allergy, eczema, or hay fever, asXolair has not been studied in these conditions.

Watch for signs of allergic reactions and other serious side effects

Xolair may cause serious side effects. You must watch for signs of these side effects while using Xolair. Seek medical help immediately if you notice any sign indicating a severe allergic reaction or other serious side effects. These signs are mentioned in “Serious side effects” in section4.

Before you or someone else injects Xolair, it is essential that they receive training from your doctor on how to recognize early symptoms of severe allergic reactions and what to do if they occur (see section3 “How to use Xolair”).Most severe allergic reactions occur during the first three doses of Xolair.

Children and adolescents

Allergic asthma

Xolair is not recommended for children under 6years of age. Its use in children under 6years of age has not been studied.

Chronic rhinosinusitis with nasal polyps

Xolair is not recommended for children and adolescents under 18years of age. Its use in patients under 18years of age has not been studied.

Other medications and Xolair

Inform your doctor, pharmacist, or nurse ifyou are taking, have recently takenor may need to take any other medication.

This is especially important if you are using:

-medicines to treat a parasitic infection, as Xolair may reduce the effect of your medicines,

-inhaled corticosteroids and other medications for allergic asthma.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. Your doctor will discuss with you the potential benefits and risks of using this medication during pregnancy.

Inform your doctor immediately if you become pregnant while being treated with Xolair.

Xolair may pass into breast milk. If you are breastfeeding or plan to do so, consult your doctor before using this medication.

Driving and operating machinery

Xolair is unlikely to affect your ability to drive and operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

How to use Xolair

Xolair is used as a subcutaneous injection (under the skin).

Xolair Injection

• You and your doctor will decide if you will inject Xolair yourself. The first three doses will be injected under the supervision of a healthcare professional (see section2).
• It is essential to have received proper training on how to inject the medication before doing it yourself.
• Your caregiver (e.g., parents) can administer the Xolair injection after receiving proper training.

For detailed instructions on how to inject Xolair, see “Xolair Pre-filled Syringe Instructions for Use” at the end of this leaflet.

Training to recognize severe allergic reactions

It is also essential that you do not inject Xolair yourself until your doctor or nurse has taught you:

• how to recognize early signs and symptoms of severe allergic reactions,
• what to do if symptoms appear.

For more information on early signs and symptoms of severe allergic reactions, see section4.

How much will be administered

Your doctor will decide the amount of Xolair you need and the frequency of administration, depending on your body weight and the results of a blood test performed before starting treatment to determine the IgE concentration in your blood.

You will need between 1 and 4injections at the same time. You will need injections every two or four weeks.

Continue taking your current medication for asthma and/or nasal polyps while undergoing Xolair treatment. Do not stop any asthma and/or nasal polyp medication without consulting your doctor.

You may not notice an improvement immediately after starting Xolair treatment. In patients with nasal polyps, effects have been observed 4weeks after starting treatment. In asthma patients, it usually takes between 12 and 16weeks for the medication to take full effect.

Use in children and adolescents

Asthma

Xolair can be used in children and adolescents aged 6years and older who are already receiving asthma medication, but whose asthma symptoms are not well controlled by medications such as high doses of inhaled steroids and inhaled beta-agonists. Your doctor will inform you of the amount of Xolair your child needs and how often it should be administered, depending on the child's weight and the results of blood tests performed before starting treatment to determine the IgE concentration in the blood.

Children (6 to 11years old) are not expected to administer Xolair themselves. However, if the doctor considers it appropriate, the caregiver can administer the injection after receiving proper training.

Chronic rhinosinusitis with nasal polyps

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

If you miss a dose of Xolair

If you have missed an appointment, contact your doctor or hospital as soon as possible to reschedule.

If you have forgotten to self-inject a dose of Xolair, inject it as soon as you remember. Then, consult your doctor to find out when the next dose should be administered.

If you interrupt Xolair treatment

Do not stop Xolair treatment unless your doctor tells you to. Stopping or discontinuing Xolair treatment may cause a recurrence of your symptoms.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects caused by Xolair are generally mild to moderate but occasionally can be severe.

Severe side effects:

Seek immediate medical attention if you notice any of the following severe side effects:

Rare (may affect up to 1 in 10,000 patients)

• Severe allergic reactions (including anaphylaxis). Symptoms may include skin rash, itching or hives, swelling of the face, lips, tongue, larynx (voice box), trachea or other parts of the body, rapid heart rate, dizziness and light-headedness, confusion, shortness of breath, labored breathing or difficulty breathing, blue skin or lips, collapse and loss of consciousness. If you have a history of severe allergic reactions (anaphylaxis) not related to Xolair, you may be at increased risk of developing a severe allergic reaction after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, joint pain and swelling, rash, fever, weight loss and fatigue.

Frequency cannot be estimated (cannot be estimated from available data)

• Churg-Strauss syndrome or hypereosinophilic syndrome. Symptoms may include one or more of the following: swelling, pain or rash around blood vessels or lymph nodes, marked elevation of a specific type of white blood cell (eosinophilia), worsening of respiratory problems, nasal congestion, heart problems, pain, numbness, tingling in the arms and legs.
• Low platelet count with symptoms such as bleeding or bruising that occur more easily than normal.
• Serum sickness. Symptoms may include one or more of the following: joint pain with or without inflammation or stiffness, rash, fever, lymph node inflammation, muscle pain.

Other side effects include:

Very common (may affect more than 1 in 10 patients)

• fever (in children)

Common (may affect up to 1 in 10 patients)

• reactions at the injection site that include pain, swelling, itching and redness
• upper stomach pain
• headache (very common in children)
• dizziness
• joint pain (arthritis)

Uncommon (may affect up to 1 in 100 patients)

• feeling sleepy or tired
• tingling or numbness in hands or feet
• syncope, postural hypotension, flushing
• sore throat, cough, acute respiratory problems
• nausea, diarrhea, indigestion
• itching, hives, rash, increased skin sensitivity to the sun
• weight gain
• flu-like symptoms
• swollen arms

Rare (may affect up to 1 in 10,000 patients)

• parasitic infection

Frequency cannot be estimated (cannot be estimated from available data)

• muscle pain and joint inflammation
• hair loss

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears onthe labeling after CAD/EXP. The expiration date is the last day of the month indicated.The container holding the pre-filled syringe can be stored for a total of 48hours at room temperature (25?°C) before use.
• Store in the original packaging to protect it from light.
• Store in the refrigerator (between 2°C and 8°C). Do not freeze.
• Do not use any container that is damaged or shows signs of deterioration.

Composition of Xolair

• The active ingredient is omalizumab.A 0.5ml syringe of solution contains 75mg of omalizumab.

-The other components arehydrochloride of arginine, hydrochloride of histidina monohidrato, histidina, polisorbate 20 and water for injectable preparations.

-The needle shield of the syringe may contain dry rubber (latex).

Appearance of the product and contents of the pack

Xolair injectable solution is presented as a transparent to slightly opalescent, colourless to pale yellowish clear solution, in a pre-filled syringe.

Xolair 75mg injectable solutionin pre-filled syringe with fixed 26 gauge needle and blue syringe shieldis available in packs containing1pre-filled syringe and in multiple packs containing 4(4x1) or10(10x1)pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

INSTRUCTIONS FOR USE OF XOLAIR PRE-FILLED SYRINGE

Read ALL the instructions before injecting the medicine. If your doctor decides that you or the person caring for you can administer your Xolair injections at home, you will need to receive training from your doctor, nurse or pharmacist before you inject the medicine or inject it for others. Children (6yearsto less than 12years of age) should not self-inject Xolair, however, if your doctor considers it appropriate, your caregiver can inject Xolair after receiving proper training. The pack contains the pre-filled syringe(s) of Xolair closed individually in a plastic tray.

Your Xolair 75mginjectable solution pre-filled syringe

Once the medicine has been injected, the syringe shield will activate to cover the needle. This is designed to protect against needlestick injuries.

What else you need for the injection:

Important safety information

Warning: Keep the syringe out of the sight and reach of children.

• The needle shield of the syringe may contain dry rubber (latex) that should not be touched by people sensitive to this substance.
• Do not open the sealed pack until you are ready to use this medicine.
• Do not use this medicine if the seal of the pack or the plastic tray is broken, as it may not be safe to use.
• Do not use if the syringe has fallen onto a hard surface or has been dropped after removing the needle shield.
• Never leave the syringe in places where others may touch it.
• Do not shake the syringe.
• Be very careful not to touch the activation clips before use. If you do, the needle shield will activate too soon.
• Do not remove the needle shield until just before injecting.
• The syringe cannot be reused. Once used, dispose of the syringe in a sharps container.

Storage of Xolairinjectable solution inpre-filled syringe

• Store this medicine sealed in its pack to protect it from light. Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE.
• Remember to take the syringe out of the refrigerator to reach room temperature (25°C) before preparing the injection (this will take 30minutes, approximately). Leave the syringe in the pack to protect it from light. The total time the syringe can remain at room temperature (25°C) before use will not exceed 48hours.
• Do not use the syringe after the expiry date shown on the pack or on the syringe label. If it has expired, return the pack to the pharmacy.

Injection site

Preparing Xolairinjectable solution in pre-filled syringe ready for use

1.Take the syringe out of the refrigerator and leave itunopenedfor 30minutes, approximately, until it reaches room temperature (leave the syringe in the pack to protect it from light).

2.When you are ready to use the syringe, wash your hands thoroughly with soap and water.

3.Disinfect the injection site thoroughly with a moist towelette soaked in alcohol.

4.Take the plastic tray out of the pack and remove the paper covering it. Hold the syringe by the blue shield and remove the syringe from the tray.

5.Inspect the syringe. The liquid should be transparent to slightly turbid. Its colour may vary from colourless to pale yellowish. There may be some small air bubbles, which is normal. DO NOT USE if the syringe is broken or if the liquid is clearly turbid, has a clearly brown colour or contains particles. In all these cases, return the pack to the pharmacy.

6.Hold the syringe horizontally to check the expiry date printed on the label through the viewer. Note: it is possible to rotate the inner part of the syringe so that the label can be read through the viewer. DO NOT USE if the medicine has expired. If it has expired, return the pack to the pharmacy.

How to use the Xolair pre-filled syringeinjectable solution

Disposal instructions