Sylatron Dosage

Recommended Dosing

• The recommended starting dose is 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.
• The recommended starting doses of SYLATRON in patients with moderate or severe renal impairment or end-stage renal disease (ESRD) are listed in Table 1. No dose adjustment is needed for patients with a creatinine clearance (CLcr) > 50 mL/min/1.73m2.

Dose Modification Guidelines

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) less than 0.5×109/L
  • Platelet Count (PLT) less than 50×109/L
  • ECOG PS greater than or equal to 2
  • Non-hematologic toxicity greater than or equal to Grade 3
• Resume dosing at a reduced dose (see Table 1) when all of the following are present:
  • Absolute Neutrophil Count (ANC) greater than or equal to 0.5×109/L
  • Platelet Count (PLT) greater than or equal to 50×109/L
  • ECOG PS 0-1
  • Non-hematologic toxicity has completely resolved or improved to Grade 1

Preparation and Administration

Reconstitute SYLATRON with 0.7 mL of Sterile Water for Injection, USP. The Sterile Water for Injection supplied contains 5 mL. Each vial of Sterile Water for Injection is intended for single dose. Discard any unused Sterile Water for Injection, USP.

• 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-dose only. DISCARD ANY UNUSED PORTION.