Malignant melanoma

Indication for Interferon, alfa-2b

Population group: Suitable for both men and women, 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

Subcutaneous

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

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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