Omalizumab Solution for injection

What is this medicine?

OMALIZUMAB (oh mah lye ZOO mab) is used to help treat allergic asthma and other allergies. 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.

What should I tell my health care provider before I take this medicine?

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

• lymphoma or other cancer

• an unusual or allergic reaction to omalizumab, hamster proteins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you with each injection. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children 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?

It is important not to miss your dose. This medicine is usually given every 2 to 4 weeks. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

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 medicine?

After receiving each injection, you will be monitored for a short time in your doctor's office or clinic.

Improvement of your asthma or allergies will not be immediate. Improvements will occur gradually.

You will have regular blood tests to determine how often you will need this medicine.

Do not stop taking any of your other asthma or allergy treatments unless otherwise directed by your doctor.

What side effects may I notice from receiving this medicine?

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

• pain, tingling, numbness in the hands or feet

• unusual bleeding or bruising

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

• headache

• mild redness, itching, swelling, or bruising at the injection site

• nausea

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 medicine?

This drug is given in a hospital or clinic and will not be stored at home.