Omalizumab-igec (By injection)

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

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

Brand Name(s):

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.
• Check the liquid in the prefilled syringe. It should be clear to cloudy, colorless to pale brownish yellow. Do not use this medicine if it is very cloudy, discolored, or if you see particles in it. Do not use the prefilled syringe if it looks damaged or has been dropped. Do not shake.
• 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 scars, moles, or skin areas that are red, bruised, tender, hard, or if there are breaks in the skin.
• To use:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow the prefilled syringe to warm to room temperature for 20 minutes before using it. Do not warm using heat sources (including hot water, microwave).
  • Remove the prefilled syringe from the carton. Do not touch the plunger rod or needle cap.
  • Hold the prefilled syringe in one hand and gently pull the cap straight off with your other hand. Do not recap the prefilled syringe.
  • Pinch the skin. With a quick and dart-like motion, insert the needle at 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 change the angle of injection or insert the needle again. Do not move when giving the injection.
  • Slowly push the plunger rod 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.
  • Slowly lift your thumb from the plunger rod until the needle is 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. Do not use if the prefilled syringe has been frozen.
• You can remove the prefilled syringe and place it back in the refrigerator if needed. The total combined time out of the refrigerator should not be more than 7 days.
• Throw away used needles in a hard, closed container that 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.
• 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-igec treatment begins. It takes time for the medicine to work. It is important to continue your omalizumab-igec 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: 5/4/2025