Sylatron Dosage

Generic name: peginterferon alfa-2b
Dosage form: injection

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

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) 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
TABLE 1: SYLATRON Dose Modifications
Starting Dose Dose Modifications for Doses 1 to 8
6 mcg/kg/week   First Dose Modification: 3 mcg/kg/week
  Second Dose Modification: 2 mcg/kg/week  
  Third Dose Modification: 1 mcg/kg/week  
  Permanently discontinue if unable to tolerate 1 mcg/kg/week  
 
Starting Dose Dose Modifications for Doses 9 to 260
3 mcg/kg/week   First Dose Modification: 2 mcg/kg/week
  Second Dose Modification: 1 mcg/kg/week  
  Permanently discontinue if unable to tolerate 1 mcg/kg/week  

Preparation and Administration

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

Table 2: Reconstitution of SYLATRON Single-Use Vials
SYLATRON
Single-Use Vial
Diluent (Sterile Water for Injection, USP) Deliverable Product and Volume Final Concentration
*
Total vial content of SYLATRON is 296 mcg.
Total vial content of SYLATRON is 444 mcg.
Total vial content of SYLATRON is 888 mcg.
200 mcg* add 0.7 mL = 200 mcg in 0.5 mL 40 mcg/0.1 mL
300 mcg add 0.7 mL = 300 mcg in 0.5 mL 60 mcg/0.1 mL
600 mcg add 0.7 mL = 600 mcg in 0.5 mL 120 mcg/0.1 mL
  • 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.
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