Omalizumab Injection

What is this medication?

OMALIZUMAB (oh mah lye ZOO mab) is used to help treat allergic asthma, chronic hives, and nasal polyps. It may be given with other treatments for these conditions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xolair, Xolair Prefilled

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• have or have had a parasite infection
• an unusual or allergic reaction to omalizumab, hamster proteins, latex, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This drug is injected under the skin. It is usually given by a health care provider in a hospital or clinic setting. It may also be given at home. If you get this medicine at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label. Keep taking it unless your health care provider tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

This medicine comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medicine. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

A special MedGuide will be given to you before each treatment or by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this drug in children. While this drug may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medicine at the hospital or clinic: It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

If you give yourself this medicine at home: If you miss a dose, take it as soon as you can. Then continue your normal schedule. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your health care provider with questions.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

After receiving each injection, you will be monitored in your doctor's office or clinic. Your doctor will determine how long you will be observed after each injection. You may need blood work done while you are taking this medicine.

Improvement of your condition will not be immediate. Improvements will occur gradually. Do not stop taking any of your other treatments unless otherwise directed by your doctor.

Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving this drug. Your healthcare provider can test your stool to check for this type of infection if you are at risk.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• pain, tingling, numbness in the hands or feet
• sudden numbness or weakness of the face, arm or leg
• symptoms of joint pain or swelling, fever, and rash
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• nausea
• pain, redness or irritation at site where injected
• runny nose
• sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in the refrigerator. Do not freeze. Keep this medicine in the original container until you are ready to take it. Protect from light. Get rid of any unused medicine after the expiration date.

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, ask your pharmacist or health care provider how to get rid of this medicine safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.