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Sylatron

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Sylatron

Indications
Dosage
How Supplied

INDICATIONS

SYLATRON™ is an alpha interferon indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.

DOSAGE AND ADMINISTRATION

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]. 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:
  • 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 0.5x109/L
    • Platelet Count (PLT) greater than or equal to 50x109/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 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
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
*Total vial content of SYLATRON is 296 mcg.
†Total vial content of SYLATRON is 444 mcg.
‡Total vial content of SYLATRON is 888 mcg.

  • 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.

HOW SUPPLIED

Dosage Forms And Strengths

  • 200 mcg of deliverable lyophilized powder per single-use vial
  • 300 mcg of deliverable lyophilized powder per single-use vial
  • 600 mcg of deliverable lyophilized powder per single-use vial

Storage And Handling

Each SYLATRON Package Contains:  
A box containing one 200 mcg per vial of SYLATRON powder and one 5 mL vial of Sterile Water for Injection, USP, 2 B-D Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-4347-01)
A box containing one 300 mcg per vial of SYLATRON powder and one 5 mL vial of Sterile Water for Injection, USP, 2 B-D Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-4348-01)
A box containing one 600 mcg per vial of SYLATRON powder and one 5 mL vial of Sterile Water for Injection, USP, 2 B-D Safety Lok syringes with a safety sleeve and 2 alcohol swabs. (NDC 0085-4349-01)

Storage

SYLATRON should be stored at 25°C (77°F); excursions permitted to 15°-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Manufactured by: Schering Corporation, a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: 8/2014

Last reviewed on RxList: 9/10/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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