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Romidepsin Dosage

Applies to the following strength(s): 10 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

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.

Comments:
-Dose reduction, discontinuation or interruption of therapy may be necessary to manage adverse reactions.
-Avoid use with rifampin and strong CYP450 3A4 inducers.

Uses:
Treatment of cutaneous T-cell Lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in patients who have received at least 1 prior systemic therapy.

Usual Adult Dose for Peripheral 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.

Comments:
-Dose reduction, discontinuation or interruption of therapy may be necessary to manage adverse reactions.
-Avoid use with rifampin and strong CYP450 3A4 inducers.

Uses:
Treatment of cutaneous T-cell Lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in patients who have received at least 1 prior systemic therapy.

Renal Dose Adjustments

Use with caution in patients with end stage renal disease (ESRD).

Liver Dose Adjustments

Use with caution in patients with moderate and severe hepatic impairment.

Dose Adjustments

Hematologic toxicities:
-Grade 3 or 4 neutropenia or thrombocytopenia: Delay treatment 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 treatment until specific cytopenia returns to Grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.

Nonhematologic toxicities except alopecia:
-Grade 2 or 3: delay treatment until toxicity returns to grade 1 or less or baseline; resume at 14 mg/m2.
-Grade 3 recurrence: Delay treatment until toxicity returns to grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.
-Grade 4: Delay treatment 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: Drug should be discontinued.

Precautions

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:
-Prior to each administration, serum potassium and magnesium must be within normal range.
-Preparation, handling, and disposal should be handled in a manner consistent with safe procedures and handling for cytotoxic drugs.
-Administer IV over a 4-hour period.
-Nausea and vomiting are commonly reported; consider anti-emetic support.

Storage requirements:
-Store in carton until use.

Reconstitution/preparation techniques:
-Reconstitution/preparation techniques: The manufacturer product information should be consulted.

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.

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.
-Closely monitor patients with advanced stage disease and/or high tumor burden; institute appropriate precautions and treat as appropriate.

Patient advice:
-Advise patients to report nausea and vomiting so that appropriate therapy can be instituted.
-Treatment can lower blood counts and lower resistance to infection. Contact physician immediately with signs or symptoms of infection, significant fatigue, or bleeding.
-If pregnancy occurs during treatment, patients should be advised to seek immediate medical advice and counseling.

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