Classes
DAE Class; Rx
Common Brand Names; Nipent, DCF, 2Deoxycoformycin
- Antineoplastics, Antimetabolites
Description
Purine nucleoside antimetabolite
Used for the treatment of hairy-cell leukemia
Use of higher than the FDA-approved doses or use with fludarabine is not recommended due to toxicity
Indications
Indicated for the treatment of hairy-cell leukemia.
For the treatment of chronic lymphocytic leukemia (CLL), in combination with cyclophosphamide and rituximab.
For stem cell transplant preparation prior to allogeneic stem cell transplantation, in combination with extracorporeal photopheresis and reduced dose total body irradiation.
For the treatment of graft-versus-host disease (GVHD). For the treatment of corticosteroid-refractory acute graft-versus-host disease (GVHD).
For the treatment of advanced cutaneous T-cell lymphoma (CTCL), including mycosis fungoides and Sezary syndrome.
Contraindications
Hypersensitivity
Concomitant fludarabine: risk of fatal pulmonary toxicity
Relative: active infections
Adverse Effects
All grades of severity are listed unless otherwise indicated
>10%
Increased creatinine (93%)
Increased creatine phosphokinase (58%)
Increased gamma glutamyl transferase (GGT) (45%)
Fatigue (43%)
Nausea (41%)
Diarrhea (36%)
Anemia (36%)
Vomiting (30%)
Increased AST/ALT (27-29%)
Abdominal pain (28%)
Constipation (22%)
Rash (22%)
Increased alkaline phosphatase (21%)
Visual impairment (20%)
Serous retinopathy/retinal pigment epithelial dystrophy (RPED) (20%)
Hemorrhage (19%)
Hyponatremia (18%)
Pyrexia (18%)
Dizziness (15%)
Leukopenia (13%)
Lymphopenia (13%)
Neutropenia (13%)
Peripheral edema (13%)
Increased GGT, Grades 3 and 4 (11%)
Hypertension (11%)
Warnings
Black Box Warnings
The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to diagnose and manage complications
Do not exceed recommended doses. Nephrotoxicity, hepatotoxicity, CNS, and pulmonary toxicity occurred in phase 1 studies that used higher doses than recommended
Do not use with concurrent fludarabine because of increased risk of pulmonary toxicity
Cautions
Epilepsy, liver dz, bone marrow depression
Weigh risk/benefit for pts w/ infections
Withhold if elevated SCr, renal dysfunction
Withhold or discontinue if evidence of CNS toxicity
Avoid pregnancy
Pregnancy and Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
Maximum Dosage
Adults
4 mg/m2 IV once every other week.
Geriatric
4 mg/m2 IV once every other week.
Adolescents
Safety and efficacy not established.
Children
Safety and efficacy not established.
How supplied
Pentostatin
powder for injection
- 10mg/vial