Indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
The indication is based on overall response rate as improvement in progression free survival or overall survival has not been demonstrated.
Treatment approved for relapsed or refractory PTCL.
May suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia.
May cause mucositis.
Mucositis may occur.
Patients should take folic acid and receive vitamin B12 to reduce treatment-related hematological toxicity and mucositis.
Dermatologic reactions, may be progressive and increase in severity with further treatment.
May be associated with tumor lysis syndrome.
Can cause hepatic toxicity and liver function test abnormalities.
Liver function tests must be monitored with holding the drug, reducing the dose or discontinuance as required.
Patients with renal function impairment may be at greater risk for increased exposure and toxicity.
Can cause fetal harm.
The most common adverse reactions are mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%).