XOLAIR 150 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Xolair 150mgpowder and solvent for solution for injection

omalizumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Xolair is and what it is used for
2. What you need to know before you receive Xolair
3. How Xolair is administered
4. Possible side effects
5. Storage of Xolair
6. Contents of the pack and further information

1. What Xolair is and what it is used for

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 medicines called monoclonal antibodies.

Xolair is used for the treatment of:

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

Allergic Asthma

This medicine is used to prevent asthma from getting worse by controlling the symptoms of severe allergic asthma in adults, adolescents, and children (from 6 years of age) who are already taking asthma medicines, but whose symptoms are not adequately controlled with medicines such as high-dose inhaled corticosteroids and inhaled beta-agonists.

Chronic Rhinosinusitis with Nasal Polyps

This medicine is used to treat chronic rhinosinusitis with nasal polyps in adults (from 18 years of age) who are taking intranasal corticosteroids (nasal spray with corticosteroids), but whose symptoms are not well controlled with these medicines. Nasal polyps are small growths in the lining of the nose. Xolair helps to reduce the size of the polyps and improve symptoms including nasal congestion, loss of sense of smell, mucus in the back of the throat, and nasal discharge.

Chronic Spontaneous Urticaria (CSU)

This medicine is used for the treatment of chronic spontaneous urticaria in adults and adolescents (from 12 years of age) who are already taking antihistamines but whose CSU symptoms are not well controlled by these medicines.

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

2. What you need to know before you receive Xolair

You should not receive Xolair

• 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 receive Xolair.

Warnings and precautions

Talk to your doctor before receiving Xolair:

• if you have kidney or liver problems,
• if you have an autoimmune disorder (a condition 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 reduce your resistance to these infections,
• if you have had a severe allergic reaction (anaphylaxis) in the past, for example, as a result of taking a medicine, an insect bite, or food.

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 (a hereditary immune disorder), aspergillosis (a lung disease caused by a fungus), food allergy, eczema, or hay fever, as Xolair 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 should watch for signs of these effects while using Xolair. Seek medical attention immediately if you notice any signs that indicate a serious side effect. These signs are mentioned in "Serious side effects" in section 4. Most serious allergic reactions occur during the first three doses of Xolair.

Children and adolescents

Allergic Asthma

Xolair 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

Xolair 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.

Chronic Spontaneous Urticaria (CSU)

Xolair is not recommended for children under 12 years of age. Its use in children under 12 years of age has not been studied.

Other medicines and Xolair

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 using:

• medicines to treat a parasitic infection, as Xolair may reduce the effect of your medicines,
• inhaled corticosteroids and other medicines for allergic asthma.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential benefits and risks of using this medicine during pregnancy.

Tell 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 breastfeed, ask your doctor for advice before taking this medicine.

Driving and using machines

Xolair is unlikely to affect your ability to drive or use machines.

3. How Xolair is administered

Instructions on how to use Xolair are provided in the "Information for healthcare professionals" section.

Xolair is administered by your doctor or nurse as an injection under the skin (subcutaneously).

Follow carefully all the instructions given by your doctor or nurse.

How much you will be given

Allergic Asthma and Chronic Rhinosinusitis with Nasal Polyps

Your doctor will decide how much Xolair you need and how often you will receive it. This depends on your body weight and the results of a blood test done before starting treatment to determine the level of IgE in your blood.

You will be given between 1 and 4 injections at the same time, every 2 or 4 weeks.

Continue taking your current asthma and/or nasal polyp medicine while you are being treated with Xolair. Do not stop any asthma and/or nasal polyp medicine without talking to your doctor.

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

Chronic Spontaneous Urticaria (CSU)

You will be given two 150 mg injections at the same time every 4 weeks.

Continue taking your current CSU medicine during treatment with Xolair. Do not stop any medicine without talking to your doctor first.

Use in children and adolescents

Allergic Asthma

Xolair may be administered to children and adolescents from 6 years of age who are already taking asthma medicine, but whose asthma symptoms are not well controlled by medicines such as high-dose inhaled corticosteroids and inhaled beta-agonists. Your doctor will tell you how much Xolair your child needs and how often it should be administered. This will depend on the child's weight and the results of blood tests done before starting treatment to determine the level of IgE in the blood.

Chronic Rhinosinusitis with Nasal Polyps

Xolair should not be administered to children and adolescents under 18 years of age.

Chronic Spontaneous Urticaria (CSU)

Xolair may be administered to adolescents from 12 years of age who are already taking antihistamines but whose CSU symptoms are not well controlled by these medicines. The dose for adolescents from 12 years of age is the same as for adults.

If you miss a dose of Xolair

Contact your doctor or hospital as soon as possible to reschedule your visit.

If you stop treatment with Xolair

Do not stop treatment with Xolair unless your doctor tells you to. Stopping or ending treatment with Xolair may cause your symptoms to come back.

However, if you are being treated for CSU, your doctor may stop treatment with Xolair from time to time to assess your symptoms. Follow your doctor's instructions.

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 Xolair are usually mild to moderate, but occasionally they can be serious.

Serious side effects:

Seek medical attention immediately if you notice any of the 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), trachea, or other parts of the body, fast heartbeat, dizziness, and lightheadedness, confusion, shortness of breath, wheezing, or difficulty breathing, blue-tinged 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 greater risk of developing a severe allergic reaction after using Xolair.
• Systemic lupus erythematosus (SLE). Symptoms may include muscle pain, pain and swelling of the joints, rash, fever, weight loss, and fatigue.

Frequency not known (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 vessels or lymph nodes, high levels of a specific type of white blood cell (marked eosinophilia), worsening respiratory problems, nasal congestion, heart problems, pain, numbness, or tingling in the arms and legs.
• Low blood platelet count with symptoms such as bleeding or bruising that occurs 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, swelling of the 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)

• injection site reactions including pain, swelling, itching, and redness
• upper stomach pain
• headache (very common in children)
• upper respiratory tract infections, such as pharyngitis and common cold
• sinusitis, sinus headache
• joint pain (arthralgia)
• feeling dizzy

Uncommon (may affect up to 1 in 100 people)

• feeling sleepy or tired
• tingling or numbness of hands or feet
• fainting, decrease in blood pressure when sitting or standing up (postural hypotension), flushing
• sore throat, cough, acute respiratory problems
• feeling sick (nausea), diarrhea, indigestion
• itching, hives, rash, increased sensitivity of the skin to the sun
• weight gain
• flu-like symptoms
• arm swelling

Rare (may affect up to 1 in 1,000 people)

• parasitic infection

Frequency not known (cannot be estimated from the available data)

• muscle pain and joint inflammation
• hair loss

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xolair

• 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 is the last day of the month shown.
• Store in a refrigerator (between 2°C and 8°C). Do not freeze.

6. Container Content and Additional Information

Xolair Composition

• The active ingredient is omalizumab. A vial contains 150 mg of omalizumab. After reconstitution, a vial contains 125 mg/ml of omalizumab (150 mg in 1.2 ml).
• The other components are sucrose, histidine, histidine hydrochloride monohydrate, and polysorbate 20.

Product Appearance and Container Content

Xolair 150 mg powder and solvent for solution for injection is presented as a white to off-white powder in a small glass vial along with an ampoule containing 2 ml of water for injections. The powder is reconstituted in water before being injected by the doctor or nurse.

Xolair 150 mg powder and solvent for solution for injection is available in packs containing 1 vial of powder and 1 ampoule of water for injections and in multiple packs containing 4 (4 x 1) vials of powder and 4 (4 x 1) ampoules of water for injections or 10 (10 x 1) vials of powder and 10 (10 x 1) ampoules of water for injections.

Not all pack sizes may be marketed.

Xolair is also available in vials with 75 mg of omalizumab.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

Ljubljana, 1526

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nuremberg

Germany

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

For further information, please contact the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu

INFORMATION FOR HEALTHCARE PROFESSIONALS

This information is intended for healthcare professionals only:

The lyophilised medicinal product requires between 15 and 20 minutes to dissolve, although in some cases it may take longer. The fully reconstituted medicinal product has a transparent to slightly opalescent appearance, colourless to pale yellowish brown, and may present a few small bubbles or foam around the edge of the vial. Due to the viscosity of the reconstituted medicinal product, care should be taken to extract all the medicinal product from the vial before removing air or excess solution from the syringe in order to obtain the 1.2 ml.

To prepare Xolair 150 mg vials for subcutaneous administration, please follow these instructions:

1. Withdraw 1.4 ml of water for injections from the ampoule with a syringe equipped with a large needle for extraction (18 gauge).

1. With the vial in a vertical position on a flat surface, insert the needle and inject the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly onto the powder.

1. Maintaining the vial in a vertical position, shake it vigorously (without agitating) for approximately 1 minute to uniformly wet the powder.

1. To aid dissolution after completing step 3, gently swirl the vial for approximately 5-10 seconds every 5 minutes to dissolve the remaining powder.

Note that in some cases it may take more than 20 minutes to dissolve the powder completely. If this is the case, repeat step 4 until the gelatinous particles have disappeared from the solution.

Once the medicinal product has dissolved completely, no gelatinous particles should be visible in the solution. Small bubbles or foam around the edge of the vial are completely normal. The reconstituted medicinal product has a transparent to slightly opalescent appearance, colourless to pale yellowish brown. Do not use the product if you observe solid particles.

1. Invert the vial for at least 15 seconds to allow the solution to flow towards the stopper. Using a new 3-ml syringe equipped with a large needle for extraction (18 gauge), insert the needle into the inverted vial. Keeping the vial in an inverted position, place the tip of the needle at the end of the solution in the vial when withdrawing the solution with the syringe. Before withdrawing the needle from the vial, pull the plunger and move it to the bottom of the syringe cylinder to withdraw all the solution from the inverted vial.

1. Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.

1. Remove air, large bubbles, and any excess solution to obtain the required dose of 1.2 ml. A thin layer of small bubbles may remain on the surface of the solution in the syringe. As the solution is slightly viscous, administration of the solution by subcutaneous injection may take between 5 and 10 seconds.

The vial provides 1.2 ml (150 mg) of Xolair. To obtain a dose of 75 mg, withdraw 0.6 ml with the syringe and discard the remaining solution.

1. Injections are administered subcutaneously into the deltoid region of the arm, the lower abdomen (but not in an area of 5 cm around the navel) or the thigh.