drug-information.ru

|Omalizumab

Omalizumab

Omalizumab is used for:

Treating moderate to severe persistent asthma in certain patients who have had a positive allergy skin test and whose symptoms are not controlled by inhaled corticosteroids.

Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody. It works by blocking your immune system"s natural response to allergens, which can lead to an acute asthma attack. This action on the immune system (specifically, IgE) helps keep your air passages open and, over time, keeps asthma under better control.

Do NOT use Omalizumab if:

• you are allergic to any ingredient in Omalizumab

Contact your doctor or health care provider right away if any of these apply to you.

Before using Omalizumab :

Some medical conditions may interact with Omalizumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances, including murine proteins
• if you have severe bronchospasms or are currently taking other medicines for asthma
• if you have a history of cancer

Some MEDICINES MAY INTERACT with Omalizumab . However, no specific interactions with Omalizumab are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Omalizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Omalizumab :

Use Omalizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not stop taking/giving or decrease the dose of any other asthma medicines unless advised to do so by your doctor. Your condition may become worse if your asthma medicines are abruptly stopped. Any decrease of your asthma medicines (eg, corticosteroids) should be done gradually under the supervision of your doctor.
• Omalizumab is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Omalizumab at home, carefully follow the injection procedures taught to you by your health care provider.
• If Omalizumab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use proper technique. Inject deep under the skin, NOT into muscle.
• Use Omalizumab regularly to receive the most benefit from it. To help you remember, use your dose on the same day of the week according to your schedule.
• Your health care provider will gradually reduce the dosage of Omalizumab as needed.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Omalizumab , contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Omalizumab .

Important safety information:

• Omalizumab may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Omalizumab . Using Omalizumab alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Omalizumab may rarely cause severe allergic reactions within 2 hours of use. Tell your doctor immediately if you experience symptoms of an allergic reaction such as hives, rash, or swelling of your throat or tongue after using Omalizumab .
• Omalizumab will not stop an asthma attack once one has started.
• The dosage is based on your body weight and blood level of IgE antibody, as well as your medical condition and response to therapy. Contact your doctor if you have a significant change in body weight during treatment. Your dose may need to be adjusted.
• It may take several months for Omalizumab to work.
• Make sure that all your doctors and laboratory personnel know that you are using Omalizumab . Omalizumab may increase the levels of IgE in your blood during therapy and for up to 1 year after discontinuing use of Omalizumab .
• LAB TESTS may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Omalizumab with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Omalizumab during pregnancy. It is unknown if Omalizumab is excreted in breast milk. If you are or will be breast-feeding while you are using Omalizumab , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Omalizumab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bruising, itching, pain, redness, stinging, swelling, or warmth at the application site; headache; itching and swelling of the skin; leg, arm, or ear pain; sinus inflammation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue or throat); dizziness; symptoms of sinus or lung infection (congestion, cough, or fever); unusual lumps, growths, or moles.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store unopened vials of Omalizumab in refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Once a vial is mixed, use the solution within 8 hours after mixing when stored between 36 and 46 degrees F (2 and 8 degrees C), or within 4 hours when stored at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use after the expiration date. Keep Omalizumab out of the reach of children and away from pets.

General information:

• If you have any questions about Omalizumab , please talk with your doctor, pharmacist, or other health care provider.
• Omalizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Omalizumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.