Dosing and uses of Nipent, DCF (pentostatin)
Adult dosage forms and strengths
powder for injection
- 10mg/vial
Hairy Cell Leukemia
4 mg/sq.meter IV (bolus or infusion) q2Weeks
Monitor: CBC, serum creatinine
Orphan Indications
Peripheral T-cell lymphomas
Cutaneous T-Cell lymphoma
Chronic lymphocytic leukemia
Orphan indications sponsor
- SuperGen, Inc; 4140 Dublin Blvd, Suite 200; Dublin, CA 94568
Other Indications & Uses
Off-label: CLL, CML, cutaneous T-cell lymphoma
Pediatric dosage forms and strengths
Safety & efficacy not established
Nipent, DCF (pentostatin) adverse (side) effects
>10%
Nausea/vomiting (63%)
Fever (46%)
Rash (43%)
Fatigue (42%)
Leukopenia (22%)
Pruritus (21%)
Cough (20%)
Chills (19%)
Myalgia (19%)
Diarrhea (17%)
Headache (17%)
Abdominal pain (16%)
Anorexia (13%)
Upper respiratory infection (13%)
Asthenia (12%)
Stomatitis (12%)
Dyspnea (11%)
Rhinitis (11%)
Immune hypersensitivity reaction (2-11% )
Neurotoxicity (1-11% )
1-10%
Hyponatremia (<3% )
Renal failure (<3% )
Pain
Pharyngitis
Thrombocytopenia
Anemia
Arthralgia
Elevated LFT's
Hypersensitivity
Skin disorders
Sweating
Viral infections
Frequency not defined
Microangiopathic hemolytic anemia
Neutropenia
Thrombotic thrombocytopenic purpura
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
Contraindications
Hypersensitivity
Concomitant fludarabine: risk of fatal pulmonary toxicity
Relative: active infections
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
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Nipent, DCF (pentostatin)
Half-Life: 5.7 hr
Peak Plasma: 3.2-9.7 ng/mL
Protein Bound: 4%
Vd: 42 L
Clearance: 68 mL/min/sq.meter
Excretion: urine (30-90%)
Mechanism of action
Inhibits adenosine deaminase -> incr dATP -> inhibits ribonucleotide reductase -> blocks DNA synthesis
Administration
IV Compatibilities
Solution: D5W, NS, Lr
Y-site: fludarabine, melphalan, ondansetron, paclitaxel, sargramostim
IV Preparation
Reconstitute 10 mg in 5 mL SWI for a final concentration 2 mg/mL
May be given by bolus or diluted to 25-50 mL with D5W to reach a final concentration of 0.33-0.16 mg/mL
IV Administration
Give 500-1000 mL of D5/½NS before infusion & 500 mL postinfusion
