Interferons

Interferons are proteins produced by your immune system in response to an infection.

Interferons work by "interfering" with the foreign invaders (bacteria or viruses) that may cause infection. Interferons can also prevent the growth and spread of other diseased cells, including some types of cancer cells.

A man-made version of one type of interferon is approved by the FDA to treat "high-risk" melanomas. It is called INTRON^® A (Interferon alfa-2b, recombinant) for Injection.

• High-risk melanomas are tumors that have a high chance of coming back, or have spread to nearby lymph nodes. A tumor is considered a "high-risk" melanoma if:
• it is more than 4 millimeters thick (approximately 1/6 of an inch) or
• it has spread to the body tissue below the skin or to a lymph node

Any melanoma that is more than 4 millimeters thick, or has spread beyond the skin, has a high chance of coming back. INTRON^® A is used to treat these high-risk melanomas within 8 weeks of surgery.

Full Prescribing Information

How Does INTRON^® A Work?

INTRON^® A (Interferon alfa-2b, recombinant) for Injection is a treatment meant for melanoma patients 18 years of age or older, whose tumors have been surgically removed but are at high risk for coming back. INTRON^® A must be used within 56 days (8 weeks) after surgery.

Scientists do not know exactly how INTRON^® A therapy works in treating melanoma. Interferons are thought to work in many ways. Interferons may directly attack the cancer cells, or they may help the immune system fight off the cancer cells.

Research has shown that INTRON^® A therapy can help some patients with melanoma live longer.

INTRON^® A (Interferon alfa-2b, recombinant) for Injection is indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery.

Important Safety Information

WARNING
Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON® A therapy.

All patients receiving INTRON® A therapy experienced mild-to-moderate side effects. Some patients experienced more severe side effects, including neutropenia, fatigue, myalgia, headache, fever, chills, and increased SGOT. Other frequently occurring side effects were nausea, vomiting, depression, alopecia, diarrhea, and thrombocytopenia.

DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HOMICIDAL IDEATION, AND AGGRESSIVE BEHAVIOR, SOMETIMES DIRECTED TOWARDS OTHERS, HAVE BEEN REPORTED IN ASSOCIATION WITH ALPHA INTERFERONS, INCLUDING
INTRON® A THERAPY. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. Patients with a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorder should not be treated with INTRON® A. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with INTRON® A be discontinued, and the patient followed with psychiatric intervention as appropriate. Cases of encephalopathy have also been observed in some patients, usually elderly, treated with higher doses of INTRON® A.

INTRON® A is contraindicated in patients with: hypersensitivity to interferon alpha or any component of the product, autoimmune hepatitis, or decompensated liver disease.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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