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Omalizumab (By injection)

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

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

Brand Name(s):

Xolair

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. You should not receive this medicine if you had an allergic reaction to omalizumab.

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.
  • Allow the prefilled syringe to warm to room temperature for 15 to 30 minutes before using it. Do not warm the medicine in any other way.
  • Check the liquid in the 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.
  • 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.
  • 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 prefilled syringe has been frozen.
  • Throw away used prefilled syringes 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

Last Updated: 12/4/2023

 

 
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