IONS
5 WARNINGS AND PRECAUTIONS
5.1 Monitoring: Laboratory Tests
5.2 Hematologic
5.3 Electrocardiographic Changes
5.4 Use in Pregnancy
5.5 Use in Women of Childbearing Potential
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Coumadin or Coumadin Derivatives
7.2 Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes
7.3 Drugs that Inhibit Drug Transport Systems
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Baseline Patient Characteristics
14.2 Clinical Results
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Storage
17 PATIENT COUNSELING INFORMATION
17.1 Instructions
FDA-Approved Patient Labeling
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
ISTODAX is indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The recommended dose of romidepsin is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8 and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the therapy.
2.2 Dose Modification
Nonhematologic toxicities except alopecia
Grade 2 or 3 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline, then therapy may be restarted at 14 mg/m2. If Grade 3 toxicity recurs, treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m2.
Grade 4 toxicity: Treatment with romidepsin should be delayed until toxicity returns to ≤Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m2.
Romidepsin should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.
Hematologic toxicities
Grade 3 or 4 neutropenia or thrombocytopenia: Treatment with romidepsin should be delayed until the specific cytopenia returns to ANC ≥1.5×109/L and/or platelet count ≥75×109/L or baseline, then therapy may be restarted at 14 mg/m2.
Grade 4 febrile (≥38.5ºC) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with romidepsin should be delayed until the specific cytopenia returns to ≤Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m2.
2.3 Instructions for Preparation and Intravenous Administration
ISTODAX should be handled in a manner consistent with recommended safe procedures for handling cytotoxic drugs.
ISTODAX must be reconstituted with the supplied diluent and further diluted with 0.9% Sodium Chloride Injection, USP before intravenous infusion.
Each 10 mg single-use vial of ISTODAX (romidepsin) must be reconstituted with 2 mL of the supplied Diluent. With a suitable syringe, aseptically withdraw 2 mL from the supplied Diluent vial, and slowly inject it into the ISTODAX (romidepsin) f |
