SYLATRON™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

Recommended Dose

• 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years.
• Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of SYLATRON and as needed for subsequent doses.

Dose Modification

Guidelines for Dose Modification provided below are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 2.0).

• Permanently discontinue SYLATRON for:
  • Persistent or worsening severe neuropsychiatric disorders
  • Grade 4 non-hematologic toxicity
  • Inability to tolerate a dose of 1 mcg/kg/wk
  • New or worsening retinopathy
• Withhold SYLATRON dose for any of the following:
  • Absolute Neutrophil Count (ANC) < 0.5x10⁹/L
  • Platelet Count (PLT) < 50x10⁹/L
  • ECOG PS ≥ 2
  • Non-hematologic toxicity ≥ Grade 3
• Resume dosing at a reduced dose (see Table 1) when all of the following are present:
  • Absolute Neutrophil Count (ANC) ≥ 0.5x10⁹/L
  • Platelet Count (PLT) ≥ 50x10⁹/L
  • ECOG PS 0-1
  • Non-hematologic toxicity has completely resolved or improved to Grade 1

TABLE 1: SYLATRON Dose Modifications

Preparation and Administration

Reconstitute SYLATRON with 0.7 mL of Sterile Water for Injection USP.

Upon reconstitution, the final concentration of SYLATRON will be

• 40 mcg per each 0.1 mL for vials containing 296 mcg of SYLATRON
• 60 mcg per each 0.1 mL for vials containing 444 mcg of SYLATRON
• 120 mcg per each 0.1 mL for vials containing 888 mcg of SYLATRON
• Swirl gently to dissolve the lyophilized powder. DO NOT SHAKE.
• Visually inspect the solution for particulate matter and discoloration prior to administration. Discard if solution is discolored, cloudy, or if particulates are present.
• Do not withdraw more than 0.5 mL of reconstituted solution from each vial.
• Administer SYLATRON subcutaneously. Rotate injection sites.
• If reconstituted solution is not used immediately, store at 2°-8°C (36°-46°F) for no more than 24 hours. Discard reconstituted solution after 24 hours. DO NOT FREEZE.
• For single-use only. DISCARD ANY UNUSED PORTION.

Dosage Forms And Strengths

• 296 mcg lyophilized powder per single-use vial
• 444 mcg lyophilized powder per single-use vial
• 888 mcg lyophilized powder per single-use vial

Storage And Handling

Storage

SYLATRON should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Manufactured by: Schering Corporation, a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: 12/2012

Last reviewed on RxList: 1/23/2013
This monograph has been modified to include the generic and brand name in many instances.