Romidepsin
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Dosage in Patients with Hepatic Impairment For patients with moderate or severe hepatic impairment, reduce the starting dose of Romidepsin for injection as shown in Table 1 and monitor for toxicities more frequently. Dosage adjustment is not required for patients with mild hepatic impairment. [See table below.]
| ULN=Upper limit of normal. | ||
| Hepatic Impairment | Bilirubin Levels | Romidepsin for injection Dose |
| Moderate | greater than 1.5 x ULN to less than or equal to 3 x ULN | 7 mg/m2 |
| Severe | greater than 3 x ULN | 5 mg/m2 |
Preparation and administration
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Instructions for Preparation and Intravenous Administration Romidepsin for injection is a hazardous drug. Use appropriate handling procedures. 1 Romidepsin for injection must be reconstituted with the supplied diluent and further diluted with 0.9% Sodium Chloride Injection, USP, before intravenous infusion. Romidepsin for injection and diluent vials contain an overfill to ensure the recommended volume can be withdrawn at a concentration of 5 mg/mL.
Each 10 mg single-dose vial of Romidepsin for injection must be reconstituted with 2.2 mL of the supplied diluent.
With a suitable syringe, aseptically withdraw 2.2 mL from the supplied diluent vial, and slowly inject it into the romidepsin for injection vial. Swirl the contents of the vial until there are no visible particles in the resulting solution. The reconstituted solution will contain romidepsin for injection 5 mg/mL. The reconstituted Romidepsin for injection vial will contain 2 mL of deliverable volume of drug product.
The reconstituted Romidepsin for injection solution is chemically stable for up to 8 hours at room temperature.
Extract the appropriate amount of Romidepsin for injection from the vials to deliver the desired dose, using proper aseptic technique. Before intravenous infusion, further dilute Romidepsin for injection in 500 mL 0.9% Sodium Chloride Injection, USP.
Infuse over 4 hours. The diluted solution is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyethylene (PE) infusion bags as well as glass bottles, and is chemically stable for up to 24 hours when stored at room temperature. However, it should be administered as soon after dilution as possible.
Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.
Drug interactions
Check romidepsin against a medication listLabel text (4 paragraphs)
7 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 ).
7.1 Warfarin or Coumarin Derivatives Prolongation of PT and elevation of INR were observed in a patient receiving romidepsin concomitantly with warfarin. Monitor PT and INR more frequently in patients concurrently receiving romidepsin and warfarin [see Clinical Pharmacology ( 12.3 )].
7.2 Drugs That Inhibit CYP3A4 Enzymes Strong CYP3A4 inhibitors increase concentrations of romidepsin [see Clinical Pharmacology ( 12.3 )]. Monitor for toxicity related to increased romidepsin exposure and follow the dose modifications for toxicity [see Dosage and Administration ( 2.2 )] when romidepsin is initially co-administered with strong CYP3A4 inhibitors.
7.3 Drugs That Induce CYP3A4 Enzymes Rifampin (a potent CYP3A4 inducer) increased the concentrations of romidepsin [see Clinical Pharmacology ( 12.3 )] . Avoid co-administration of romidepsin with rifampin. The use of other potent CYP3A4 inducers should be avoided when possible.
Contraindications
None. None ( 4 ).
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies, romidepsin can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data on romidepsin use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. In an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see Data ).
Advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving romidepsin and for at least 1 month after the last dose. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Romidepsin was administered intravenously to pregnant rats during the period of organogenesis at doses of 0.1, 0.2, or 0.5 mg/kg/day.
Substantial resorption or postimplantation loss was observed at the high dose of 0.5 mg/kg/day, a maternally toxic dose. Adverse embryo-fetal effects were noted at romidepsin doses of ≥0.1 mg/kg/day, with systemic exposures (AUC) ≥0.2% of the human exposure at the recommended dose of 14 mg/m 2 /week. Drug-related fetal effects consisted of reduced fetal body weights, folded retina, rotated limbs, and incomplete sternal ossification.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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