Omalizumab (oh-ma-LIZ-oo-mab)

Treats asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic idiopathic urticaria, and food allergy.

Brand Name(s):

Xolair, Xolair Autoinjector, Xolair PFS

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the upper arms, stomach, or thighs.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes in 2 forms: an autoinjector and a prefilled syringe. Your doctor will tell you which dosage form you should use.
• Check the liquid in the autoinjector or prefilled syringe. It should be clear and colorless to pale brownish yellow. Do not use this medicine if it is cloudy, discolored, or if you see particles in it. Do not use the autoinjector or prefilled syringe if it looks damaged or has been dropped.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into moles or scars, or skin areas that are red, bruised, tender, hard, or not intact.
• Autoinjector:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow the autoinjector to warm to room temperature for 30 to 45 minutes before using it. Do not warm using heat sources (including warm water, microwave).
  • Do not hold the autoinjector by the cap. Hold the autoinjector by the middle. Do not remove the cap until you are ready to inject.
  • Hold the autoinjector with one hand and pull the cap straight off with your other hand. Do not twist the cap. Do not put the cap back on.
  • Hold the autoinjector at a 90 degree angle. Place the autoinjector flat against your skin, then firmly press down. You will hear a "click" sound. Your injection begins when the first click is heard. Do not move the autoinjector.
  • Keep holding the autoinjector against your skin. The green indicator will move within the viewing window. You will hear a second click. The second click tells you that the injection is almost complete. You will see the green indicator stop moving and completely fill the viewing window. If the window has not turned green, this means you may not have received the full dose.
  • Remove the autoinjector by pulling it straight up from the skin. The needle guard will automatically extend and lock over the needle.
• Prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow the prefilled syringe to warm to room temperature for 15 to 30 minutes before using it. Do not warm using heat sources (including warm water, microwave).
  • Peel off the blister pack cover. Do not flip the blister pack upside down to take out the prefilled syringe. Hold the middle part of the prefilled syringe when taking it out. Do not touch the needle-shield wings. Do not hold the plunger or needle cap.
  • Hold the prefilled syringe firmly with one hand and pull the needle cap straight off with your other hand. Do not twist the needle cap. Do not hold, push, or pull the plunger while removing the needle cap. Do not touch the needle or let it touch any surfaces. Do not recap the needle.
  • Pinch the skin. Insert the needle into your skin at about a 45 to 90 degree angle. Do not touch the plunger while inserting the needle into the skin. Do not insert the needle through clothing. Do not move and avoid sudden movements when giving the injection.
  • Push the plunger head all the way down until all the medicine is injected. If the plunger is not fully pressed, the needle-shield will not extend to cover the needle when it is removed.
  • Release the plunger and allow the needle to be covered by the needle-shield.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep the medicine in the original carton until you are ready to use it. Throw away any unused medicine after 4 hours of removing from the refrigerator. Do not use if the autoinjector or prefilled syringe has been frozen.
• Before giving an injection, you can remove the carton and place it back in the refrigerator if needed. The total combined time out of the refrigerator should not be more than 2 days.
• Throw away the used autoinjector or prefilled syringe in a sharps disposal container or in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have sudden breathing problems, or a history of cancer or a parasite infection. Tell your doctor if you have an allergy to latex.
• This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an asthma attack.
• If you use a corticosteroid medicine (inhaled or taken by mouth) to treat your asthma or nasal polyps, keep using it unless your doctor tells you otherwise.
• You may not see immediate improvement in your asthma after omalizumab treatment begins. It takes time for the medicine to work. It is important to continue your omalizumab injections until your doctor tells you otherwise.
• This medicine may cause the following problems:
  • Eosinophilia (increased white blood cell count)
  • Vasculitis (inflammation of the blood vessels)
  • Increased risk of cancer or infections
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bone pain, difficulty in moving
• Fast heartbeat, trouble breathing, chest pain
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Lightheadedness, dizziness, or fainting
• Stomach pain
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Arm, leg, joint, or muscle pain
• Earache
• Headache, nausea
• Pain, itching, burning, swelling, or lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088