Malignant melanoma

Active Ingredient: Interferon, alfa-2b

Indication for Interferon, alfa-2b

Population group: only adults (18 years old or older)

For this indication, competent medicine agencies globally authorize below treatments:

10-20 million IU/m² once every other day

Route of admnistration


Defined daily dose

10,000,000 - 20,000,000 [iU] per m² of body surface area (BSA)

Dosage regimen

From 10,000,000 To 20,000,000 [iU] per m² of body surface area (BSA) once every day for 28 day(s)

Loading dose

20,000,000 [iU] per m² of body surface area (BSA)

Maintenance dose

10,000,000 [iU] per m² of body surface area (BSA)

Detailed description

As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/m² daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/mL (0.9%) solution for injection and administered as a 20-minute infusion. As maintenance treatment, the recommended dose is 10 million IU/m² administered subcutaneously three days a week (every other day) for 48 weeks.

If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to <500/mm³ or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to >5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates. Interferon alfa-2b treatment is to be restarted at 50% of the previous dose. If intolerance persists after dose adjustment or if granulocytes decrease to <250/mm³ or ALT/AST rises to >10 x upper limit of normal, discontinue interferon alfa-2b therapy.

Although the optimal (minimum) dose for full clinical benefit is unknown, patients must be treated at the recommended dose, with dose reduction for toxicity as described.

Active ingredient

Interferon, alfa-2b

Recombinant interferon alfa-2b is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques. Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface. Recombinant interferon alfa-2b has exhibited antiproliferative effects in studies employing both animal and human cell culture systems as well as human tumour xenografts in animals. It has demonstrated significant immunomodulatory activity in vitro.

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