Clinical Information
Gen. Code and Des.
66174 romidepsin INTRAVEN VIAL 10 MG/2 ML
GCN and Des.
28397 romidepsin INTRAVEN VIAL 10 MG/2 ML
Strength
10MG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
13396 romidepsin 128517077
Inactive Ingredients
1539 ethyl alcohol 64175
2468 propylene glycol 57556
2537 povidone 9003398
These highlights do not include all the information needed to use ROMIDEPSIN FOR INJECTION safely and effectively. See full prescribing information for ROMIDEPSIN FOR INJECTION.
ROMIDEPSIN for injection, for intravenous use
Initial U.S. Approval: 2009
INDICATIONS AND USAGE
Romidepsin for injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy (1).
DOSAGE AND ADMINISTRATION
14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Repeat cycles every 28 days provided that the patient continues to benefit from and tolerates the drug (2.1).
Discontinue or interrupt treatment (with or without dose reduction to 10 mg/m2) to manage drug toxicity (2.2).
Reduce starting dose in patients with moderate and severe hepatic impairment (2.3).
DOSAGE FORMS AND STRENGTHS
For injection: 10 mg of romidepsin as a lyophilized powder in single-dose vial for reconstitution (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
Myelosuppression: romidepsin can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with romidepsin; interrupt and/or modify the dose as necessary (5.1).
Infections: Fatal and serious infections. Reactivation of DNA viruses (Epstein Barr and hepatitis B). Consider monitoring and prophylaxis in patients with evidence of prior hepatitis B (5.2).
Electrocardiographic (ECG) changes: Consider cardiovascular monitoring in patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking medicinal products that lead to significant QT prolongation. Ensure that potassium and magnesium are within the normal range before administration of romidepsin (5.3).
Tumor lysis syndrome: Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and appropriate precautions taken (5.4).
Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception (5.5, 8.1, 8.3).
ADVERSE REACTIONS
The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritus. Grade 3-4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered romidepsin and warfarin or coumarin derivatives (7.1).
Monitor for toxicities related to increased romidepsin exposure when co- administering romidepsin with strong CYP3A4 inhibitors (7.2).
Avoid use with rifampin and strong CYP3A4 inducers (7.3).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2021
