Anaphylaxis (e.g., bronchospasm, hypotension, syncope, urticaria, angioedema of throat or tongue) reported.
Anaphylaxis can occur after the first or second dose of omalizumab, but may occur after >1 year of therapy. Monitor patient for an appropriate period of time following administration. (See Cautions: Medical Personnel and Facilities and see Sensitivity Reactions.)
Administer omalizumab in a setting prepared to manage potentially life-threatening anaphylaxis; clinicians administering the drug should be familiar with management of anaphylaxis.
Inform patient of the signs and symptoms of anaphylaxis and instruct patient to obtain immediate medical care should symptoms develop.
REMS:
FDA approved a REMS for omalizumab to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of omalizumab and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
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
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.
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.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
