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Home » Drug Information » FDA Approved Drugs » 2011
Medical Areas: Dermatology | Oncology | Family Medicine

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Sylatron (peginterferon alfa-2b)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Merck
Approval Status: Approved April 2011
Treatment Area: melanoma

General Information

Sylatron is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

Sylatron is specifically indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

Sylatron is supplied as a powder for reconstitution into a solution designed for subcutaneous administration. The recommended initial dose is 6 mcg/kg/week subcutaneously for eight doses, followed by 3 mcg/kg/week subcutaneously for up to five years. Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of Sylatron and as needed for subsequent doses.

Clinical Results

FDA Approval
The FDA approval of Sylatron was based on an open-label, multicenter, randomized study conducted in 1256 subjects with surgically resected, AJCC Stage III melanoma within 84 days of regional lymph node dissection. The subjects were randomized to observation (no therapy) or to Sylatron at a dose of 6 mcg/kg by subcutaneous injection once weekly for eight doses followed by a 3 mcg/kg subcutaneous injection once weekly for a period of up to five years. The main outcome measure was relapse-free survival (RFS), defined as the time from randomization to the earliest date of any relapse (local, regional, in-transit, or distant), or death from any cause. Secondary outcome measures included overall survival. The median RFS was 34.8 months and 25.5 months in the Sylatron and observation arms, respectively. There was no statistically significant difference in survival between the Sylatron and the observation arms.

Side Effects

Adverse events associated with the use of Sylatron may include, but are not limited to, the following:

  • fatigue
  • increased ALT
  • increased AST
  • pyrexia
  • headache
  • anorexia
  • myalgia
  • nausea
  • chills
  • injection site reaction

.

Mechanism of Action

Sylatron is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

Literature References

Bouwhuis MG, Suciu S, Testori A, Kruit WH, Salès F, Patel P, Punt CJ, Santinami M, Spatz A, Ten Hagen TL, Eggermont AM Phase III trial comparing adjuvant treatment with pegylated interferon Alfa-2b versus observation: prognostic significance of autoantibodies--EORTC 18991. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2010 May 10;28(14):2460-6

Additional Information

For additional information regarding Sylatron or melanoma, please visit the Merck web page.