Romidepsin Dosage

Medically reviewed by Drugs.com. Last updated on Aug 16, 2024.

Usual Adult Dose for Cutaneous T-cell Lymphoma

14 mg/m2 IV over 4 hours on days 1, 8, and 15 of a 28-day cycle; repeat cycle every 28 days provided patient continues to benefit and is tolerating therapy

Uses: For the treatment of cutaneous T-cell Lymphoma (CTCL) in patients who have received at least 1 prior systemic therapy.

Renal Dose Adjustments

• Mild, Moderate and Severe Renal Dysfunction: No adjustment recommended
• End stage renal disease (ESRD): No data available

Liver Dose Adjustments

• Mild Liver Dysfunction: No adjustment recommended.
• Moderate Liver Dysfunction (bilirubin greater than 1.5 x upper limit of normal [ULN] to 3 x ULN or less): Reduce dose to 7 mg/m2.
• Severe Liver Dysfunction (bilirubin greater than 3 x ULN): Reduce dose to 5 mg/2.

Dose Adjustments

NONHEMATOLOGIC TOXICITIES (EXCEPT ALOPECIA):

• Grade 2 or 3: Delay therapy until toxicity returns to Grade 1 or less or baseline; resume at 14 mg/m2.
• Grade 3 recurrence: Delay therapy until toxicity returns to Grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.
• Grade 4: Delay therapy until toxicity returns to Grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.
• Grade 3 or 4 recurrence after dose reduction: Discontinue therapy.

HEMATOLOGIC TOXICITIES:

• Grade 3 or 4 neutropenia or thrombocytopenia: Delay therapy until specific cytopenia returns to absolute neutrophil count (ANC) of 1.5 x 10(9)/L or greater and/or platelet count is 75 x 10(9)/L or baseline; restart at 14 mg/m2.
• Grade 4 febrile (38.5C or greater) neutropenia or thrombocytopenia requiring platelet transfusion: Delay therapy until specific cytopenia returns to Grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer IV over a 4-hour period.
• Nausea and vomiting are commonly reported; consider antiemetic support.

Storage requirements:

• This drug is supplied as a kit containing 2 vials in a single carton.
• Store carton at 20C to 25C; excursions permitted between 15C to 30C.

Reconstitution/preparation techniques:

• Read the US FDA-approved patient labeling for further preparation and administration instructions.
• Preparation, handling, and disposal should be handled in a manner consistent with safe procedures and handling for cytotoxic drugs.

General:

• Reconstituted solution (5 mg/mL) is chemically stable for up to 8 hours at room temperature.
• Diluted solution is chemically stable for up to 24 hours at room temperature; however, administration as soon as possible following dilution is advised.
• Prolongation of PT and elevation of INR were observed in a patient receiving this drug concomitantly with warfarin. Monitor PT and INR more frequently in these patients.
• Strong CYP450 3A4 inhibitors increase concentrations of this drug. Monitor for toxicity related to increased exposure to this drug and follow the dose modifications for toxicity.
• Rifampin (a potent CYP450 3A4 inducer) increases the concentrations of this drug. Avoid coadministration of this drug with rifampin. The use of other potent CYP450 3A4 inducers should be avoided when possible.

Monitoring:

• Perform ECG at baseline and periodically, especially in patients with a history of significant cardiovascular disease, those on concomitant QT interval prolonging drugs, or those receiving antiarrhythmic drugs.
• Verify normal serum potassium and magnesium levels prior to initiating treatment, and periodically during therapy, especially in higher risk patients.
• Monitor for thrombocytopenia, anemia, neutropenia and lymphopenia during therapy; modify treatment as necessary.
• Monitor patients with advanced stage disease and/or high tumor burden; institute precautions and treat as needed.

Patient advice:

• Read the Patient Information and Instructions for Use.
• Report nausea and vomiting to your healthcare provider.
• This drug can lower blood counts and lower resistance to infection; contact your healthcare provider immediately if you experience with signs of infection, significant fatigue, or bleeding.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer