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Istodax Generic Name & Formulations
Legal Class
Rx
General Description
Romidepsin 10mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains povidone.
Pharmacological Class
Histone deacetylase inhibitor.
How Supplied
Kit—1 (vial + diluent)
Manufacturer
Generic Availability
YES
Istodax Indications
Indications
Cutaneous T-cell lymphoma in patients who have received at least one prior systemic therapy.
Istodax Dosage and Administration
Adult
≥18yrs: Give by IV infusion over 4hrs. 14mg/m2 on days 1, 8, and 15 of a 28-day cycle; repeat cycle every 28 days; continue as tolerated and as beneficial. May interrupt, reduce dose to 10mg/m2, or discontinue based on toxicities; see full labeling. Hepatic impairment: moderate (bilirubin >1.5–≤3×ULN): reduce initial dose to 7mg/m2; severe (bilirubin >3×ULN): reduce initial dose to 5mg/m2.
Children
<18yrs: not established.
Istodax Contraindications
Not Applicable
Istodax Boxed Warnings
Not Applicable
Istodax Warnings/Precautions
Warnings/Precautions
Increased risk of serious infections (eg, pneumonia, sepsis, Epstein Barr, HBV). Prior history of hep B infection; consider monitoring for reactivation and give antiviral prophylaxis. Correct electrolyte imbalances (esp. K+, Mg++) before starting. Monitor ECG and electrolytes in congenital long QT syndrome, significant cardiovascular disease. Advanced stage disease and/or high tumor syndrome: monitor closely for tumor lysis syndrome. Moderate or severe hepatic impairment: reduce dose (see Adult); monitor more frequently esp during 1st cycle. End-stage renal disease. Monitor CBCs with differential. Embryo-fetal toxicity. Advise to use effective non-estrogen containing contraception (eg, condoms, IUDs) during and for 1 month after the last dose. Pregnancy: exclude status within 7 days prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Istodax Pharmacokinetics
See Literature
Istodax Interactions
Interactions
Caution with other drugs that can cause QT prolongation (monitor). Monitor PT/INR with warfarin. Potentiated by drugs that inhibit P-gp and CYP3A4; avoid concomitant strong CYP3A4 inhibitors (eg, azole antifungals, protease inhibitors, clarithromycin, telithromycin, nefazodone). Caution with moderate CYP3A4 inhibitors. Avoid concomitant rifampin. May be antagonized by other strong CYP3A4 inducers (eg, dexamethasone, carbamazepine, phenytoin, phenobarbital, rifabutin, rifapentine, St. John’s Wort); avoid when possible. May antagonize estrogen-containing contraceptives; use alternative methods.
Istodax Adverse Reactions
Adverse Reactions
Nausea, fatigue, infections, vomiting, anorexia, ECG ST-T wave changes, dysgeusia, constipation, pruritus, anemia, thrombocytopenia, neutropenia, lymphopenia; tumor lysis syndrome.
Istodax Clinical Trials
See Literature
Istodax Note
Not Applicable
Istodax Patient Counseling
See Literature
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