Sylatron Dosage

Medically reviewed by Drugs.com. Last updated on Nov 2, 2020.

Generic name: peginterferon alfa-2b 40ug in 0.1mL;
Dosage form: injection

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 [see Use in Specific Populations (8.7)]. No dose adjustment is needed for patients with a creatinine clearance (CLcr) > 50 mL/min/1.73m2.

Table 1: Recommended Starting Dose for Moderate and Severe Renal Impairment and End-Stage Renal Disease
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

Table 2: 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. 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.

Table 3: Reconstitution of SYLATRON Single-Dose Vials
SYLATRON Single-Dose 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-dose only. DISCARD ANY UNUSED PORTION.