Sylatron Dosage
Generic name: peginterferon alfa-2b 40ug in 0.1mL;
Dosage form: injection
Drug classes: Antineoplastic interferons, Antiviral interferons
Medically reviewed by Drugs.com. Last updated on Oct 23, 2024.
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.
| Degree of Renal Impairment | Creatinine Clearance (mL/min/1.73m2) | Initial doses for 8 weeks | Follow-up doses for 5 years |
|---|---|---|---|
| Moderate | 30 – 50 | 4.5 mcg/kg/week | 2.25 mcg/kg/week |
| Severe | <30 | 3 mcg/kg/week | 1.5 mcg/kg/week |
| End-Stage Renal Disease | On dialysis | 3 mcg/kg/week | 1.5 mcg/kg/week |
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
| 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. 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.
| SYLATRON Single-Dose Vial | Diluent (Sterile Water for Injection, USP) | Deliverable Product and Volume | Final Concentration | ||
|---|---|---|---|---|---|
| 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-dose only. DISCARD ANY UNUSED PORTION.
More about Sylatron (peginterferon alfa-2b)
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- Drug class: antineoplastic interferons
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