Sylatron

Sylatron Manufacturers

• Merck Sharp & Dohme Corp.
  

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  Sylatron | Merck Sharp & Dohme Corp.

  

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  2.1 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 2.2 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 2.3 Preparation and Administration

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

  Table 3: 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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• Merck Sharp & Dohme Corp.
  

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  Sylatron | Merck Sharp & Dohme Corp.

  

  ---

  2.1 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 2.2 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 2.3 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 use. Discard any unused Sterile Water for Injection, USP.

  Table 3: 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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