Home Drug Guide Romidepsin

Drug Guide

Generic Name

Romidepsin

Brand Names Istodax

Classification

Therapeutic: Antineoplastic

Pharmacological: Histone Deacetylase Inhibitor

FDA Approved Indications

Treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy
Treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy

Mechanism of Action

Romidepsin inhibits histone deacetylases, leading to accumulation of acetylated histones, resulting in chromatin remodeling, cell cycle arrest, and apoptosis of malignant cells.

Dosage and Administration

Adult: Initial dose of 14 mg/m² IV administered once weekly for 2 consecutive days in a 21-day cycle. Dose adjustments may be required based on toxicity.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dosage adjustment; use with caution.

Renal Impairment: No specific adjustment; use with caution.

Hepatic Impairment: Dose modifications are recommended for hepatic impairment, particularly in severe cases.

Pharmacokinetics

Absorption: Bioavailability data are limited; administered intravenously.

Distribution: Wide distribution with high binding to plasma proteins.

Metabolism: Primarily hepatic via CYP3A4 enzyme.

Excretion: Excreted mainly in feces; some renal excretion.

Half Life: Approximately 3 hours.

Contraindications

Hypersensitivity to romidepsin or its components.

Precautions

Monitor for ECG changes due to potential QT prolongation, hepatic function, and hematologic toxicities. Use with caution in patients with significant cardiac history, infections, or blood dyscrasias.

Adverse Reactions - Common

Nausea (Frequent)
Fatigue (Frequent)
Thrombocytopenia (Frequent)
Anemia (Frequent)
Neutropenia (Frequent)

Adverse Reactions - Serious

QT prolongation leading to arrhythmias (Uncommon)
Infections including pneumonia, sepsis (Uncommon)
Second primary malignancies (Rare)

Drug-Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) – may increase romidepsin levels.
QT-prolonging agents – risk of additive QT prolongation.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor cardiac status (ECGs), blood counts, hepatic function, and electrolyte levels.

Diagnoses:

Risk for falls related to hypotension or dizziness
Risk for infection related to myelosuppression

Implementation: Administer as per schedule, monitor for toxicities, manage hematologic parameters, and provide supportive care.

Evaluation: Assess for therapeutic response and adverse effects, modify treatment as needed.

Patient/Family Teaching

Report signs of infection, bleeding, or unusual bruising.
Use effective contraception during and for at least 3 months after treatment.
Avoid radiation therapy or drugs that prolong QT interval without medical advice.

Special Considerations

Black Box Warnings:

QT prolongation and associated serious cardiac arrhythmias, including torsade de pointes.
Risk of infections, including fatal and opportunistic infections.
Second primary malignancies.

Genetic Factors: No specific genetic testing is required.

Lab Test Interference: Can cause hematologic abnormalities that may interfere with lab assessments.

Overdose Management

Signs/Symptoms: Severe nausea, vomiting, hypotension, arrhythmias, or bleeding.

Treatment: Supportive care, discontinuation of romidepsin, and management of symptoms; no specific antidote.

Storage and Handling

Storage: Store vials at 2°C to 25°C (36°F to 77°F).

Stability: Stable until expiration date when stored properly.