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November 25, 2009
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ANAKINRA-INJECTABLE (cont.)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, swelling, irritation), headache, nausea, or diarrhea may occur. If any of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these serious side effects occur: flu-like symptoms (e.g., fever, chills, sore throat, unusual weakness, muscle aches), sinus pain, stomach pain. Tell your doctor immediately if any of these unlikely but serious side effects occur: skin swelling/redness (especially at areas other than the injection site), trouble breathing. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor your medical history, especially of: kidney problems, asthma, immune system problems, any allergies. This medication may affect your immune system function. Do not have immunizations/vaccinations without the consent of your doctor because they may not be effective. Avoid live vaccines (e.g., oral polio vaccine) while using this medicine. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug. This medication is not recommended for use in children under 18 years of age. Tell your doctor if you are pregnant before using this medication. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you may use, especially: certain other rheumatoid arthritis drugs (e.g., tumor necrosis factor drugs such as etanercept, adalimumab, or infliximab), drugs that may suppress your immune system (e.g., cancer chemotherapy or corticosteroids such as prednisone). Do not start or stop any medicine without doctor or pharmacist approval.




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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