Romidepsin

INTRODUCTION

Indications

Treatment of cutaneous T-cell lymphoma (CTCL) that has not responded to at least one prior systemic therapy.

Action

Acts as an inhibitor of histone deacetylase (HDAC). HDACs modulate gene expression and transcription factors. Inhibition results in cell cycle arrest and apoptosis; Therapeutic Effects: ↓ extent and spread of CTCL.

Adverse Reactions/Side Effects

CNS: fatigue. CV: ECG changes. GI: anorexia, nausea, vomiting. Hemat: ANEMIA, LEUKOPENIA, THROMBOCYTOPENIA.

PHYSICAL THERAPY IMPLICATIONS

Examination and Evaluation

• Watch for signs of leukopenia (fever, sore throat, other signs of infection), thrombocytopenia (bruising, nose bleeds, bleeding gums), or unusual weakness and fatigue that might be due to anemia. Report these signs to the physician or nursing staff immediately.

• Assess heart rate, ECG, and heart sounds, especially during exercise (See Appendices G, H). Report any rhythm disturbances or symptoms of increased arrhythmias, including palpitations, chest discomfort, shortness of breath, fainting, and fatigue/weakness.

Interventions

• For patients who are medically able to begin exercise, implement appropriate resistive exercises and aerobic training to maintain muscle strength and aerobic capacity during cancer chemotherapy or to help restore function after chemotherapy.

• Because of potential ECG changes, use caution during aerobic exercise and other forms of therapeutic exercise. Assess exercise tolerance frequently (blood pressure, heart rate, fatigue levels), and terminate exercise immediately if any untoward responses occur (See Appendix L).

Patient/Client-Related Instruction

• Advise patient and family/caregivers that fatigue and weakness are likely, and may be severe. Implement assistive devices (walker, cane, wheelchair) as needed to help maintain mobility and prevent falls.

• instruct patient to report severe or prolonged GI problems, such as nausea, vomiting, and loss of appetite.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Protein Binding: 92–94%.

Metabolism and Excretion: Extensively metabolized, mostly by the CYP3A4 enzyme system

Half-life: 3 hr.

Contraindications/Precautions

Contraindicated in: OB: Pregnancy (may cause fetal harm); Lactation: Avoid use.

Use Cautiously in: Congenital long QT syndrome, history of significant cardiovascular disease, concurrent antiarrhythmics or other medications that cause significant QT prolongation (↑ risk of arrhythmias); Electrolyte abnormalities (correct magnesium and potassium abnormalities prior to use); Moderate-to-severe hepatic impairment or end-stage renal disease; Geri: Elderly patients may be more sensitive to drug effects; Pedi: Safe ...