romidepsin (Rx)

Brand and Other Names:Istodax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable lyophilized powder

  • 10mg/vial plus diluent vial
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Cutaneous T-Cell Lymphoma

Indicated for CTCL in patients who have received at least 1 prior systemic therapy

14 mg/m² IV infused over 4 hr on days 1, 8, and 15 of 28-d cycle  

Treatment discontinuation or interruption with or without dose reduction to 10 mg/m² may be required to manage adverse effects

Peripheral T-Cell Lymphoma

Indicated for PTCL in patients who have received at least 1 prior systemic therapy

14 mg/m² IV infused over 4 hr on days 1, 8, and 15 of 28-d cycle  

Treatment discontinuation or interruption with or without dose reduction to 10 mg/sq.meter may be required to manage adverse effects

Dosage Modifications

Nonhematologic toxicities (except alopecia)

  • Grade 2 or 3 toxicity: Hold treatment until toxicity declines to Grade 1 or baseline, then restart at 14 mg/m²
  • If Grade 3 toxicity recurs, hold treatment until toxicity returns to Grade 1 or baseline and the dose should be permanently reduced to 10 mg/m²
  • Grade 4 toxicity: Hold treatment until toxicity declines to Grade 1 or baseline, then the dose should be permanently reduced to 10 mg/m²
  • Discontinued if Grade 3 or 4 toxicities recur after dose reduction

Hematologic toxicities

  • Grade 3 or 4 neutropenia or thrombocytopenia: Hold treatment until toxicity improves to ANC >1.5×10^9/L and/or platelet count >75×10^9/L or baseline, then restart at 14 mg/m²
  • Grade 4 febrile (>38.5 degrees C) 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

Renal or hepatic impairment

  • Use caution with severe hepatic impairment or end-stage renal disease

Administration

Procedures for safe handling of cytotoxic drugs apply

Safety and efficacy not established

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Interactions

Interaction Checker

and romidepsin

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            Adverse Effects

            >10%

            Asthenia/fatigue (53-77%)

            Anorexia (23-54%)

            Constipation (12-40%)

            Diarrhea (20-36%)

            Nausea (56-86%)

            Vomiting (34-52%)

            Anemia (19-72%)

            Hypomagnesemia (22-28%)

            Neutropenia (11-66%)

            Thrombocytopenia (17-72%)

            Infections (46-54%)

            <10%

            Hypotension

            EKG changes

            Exfoliative dermatitis

            Pruritus

            Hypocalcemia

            Hypokalemia

            Leukopenia

            Lymphopenia

            Hypoalbuminemia

            Hyperglycemia

            Hyponatremia

            Increased LFTs

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            QT prolongation; potassium and magnesium should be within normal limits before administration

            Coadministration with other drugs that prolong QT interval (eg, sotalol, dofetilide, erythromycin) may increase risk for serious arrhythmias

            Tumor lysis syndrome has been reported; Patients with advanced stage disease and/or high tumor burden should be closely monitored and appropriate precautions taken

            Monitor hematologic parameters; interrupt/discontinue treatment if thrombocytopenia, leukopenia, or anemia becomes severe

            Serious and sometimes fatal infections reported with 30 days after treatment including pneumonia, sepsis, and viral reactivation (eg, Epstein Barr and hepatitis B viruses); risk may be greater in patients with a history of monoclonal antibodies treatment directed against lymphocyte antigens and in patients with disease involvement of the bone marrow

            Avoid during pregnancy, no adequate trials exist; based on MOA, likely to cause fetal harm

            Binds to estrogen and may reduce effectiveness of oral contraceptives

            May increase effect of warfarin (prolonged PT, increased INR)

            Strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase romidepsin serum levels

            Potent CYP3A4 inducers (eg, dexamethasone, carbamazepine, phenytoin, rifampin, rifabutin, rifapentine, phenobarbital, St. John’s Wort) may decrease romidepsin serum levels

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            Pregnancy & Lactation

            Pregnancy Category: D

            Based on its mechanism of action and findings in animals, romidepsin may cause fetal harm when administered to pregnant women

            Embryocidal in an animal reproductive study; resulted in adverse effects on the developing fetus at exposures below those in patients at the recommended dose of 14 mg/sq.meter/week

            Lactation: Unknown if excreted in breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Histone deacetylase (HDAC) inhibitor; induces arrest in the cell cycle at G1 and G2/M phases, which in turn causes cell death

            Pharmacokinetics

            Half-life: 3 hr

            Cmax: 377 ng/mL

            AUC: 1549 ng*hr/mL

            Protein Bound: 92-94%

            Metabolism: Extensively by CYP3A4

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            Administration

            IV Compatibility

            Solution: 0.9% NaCl

            IV Preparation

            Handle according to recommended safe handling procedures for cytotoxic drugs

            Each 10 mg single-dose vial must be reconstituted with 2.2 mL of supplied diluent.

            With a suitable syringe, aseptically withdraw 2.2 mL from supplied diluent vial, and slowly inject into vial for injection; swirl the contents of the vial until there are no visible particles in the resulting solution; the reconstituted solution will contain 5 mg/mL; the reconstituted vial will contain 2 mL of deliverable volume of drug product; the reconstituted solution is chemically stable for up to 8 hours at room temperature

            Extract the appropriate amount from the vials to deliver desired dose, using proper aseptic technique; before intravenous infusion, further dilute in 500 mL 0.9% Sodium Chloride Injection, USP

            IV Administration

            Administer & dispose according to recommended safe handling procedures for cytotoxic drugs

            Infuse IV over 4 hr

            Administer IV infusion via volumetric infusion pump

            Diluted solution compatible w/ PVC, EVA, PE infusion bags, or glass bottles

            Stability

            Store according to recommended safe handling procedures for cytotoxic drugs

            Reconstituted solution stable for at least 8 hr at room temp

            Diluted solution stable for 24 hr at room temp

            Store unreconstituted vials between 20-25% at controlled room temp

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.