Last reviewed · How we verify
Nipent (PENTOSTATIN)
Nipent (Pentostatin) is a small molecule nucleoside metabolic inhibitor that targets adenosine deaminase. It was originally developed by Hospira Inc and is currently owned by the same company. Nipent is FDA-approved for the treatment of hairy cell leukemia and has been off-patent since its approval in 1991. The drug has a half-life of 5.3 hours and is available from generic manufacturers. As an off-patent medication, Nipent is no longer protected by active patents.
At a glance
| Generic name | PENTOSTATIN |
|---|---|
| Sponsor | Hospira Inc |
| Drug class | Nucleoside Metabolic Inhibitor [EPC] |
| Target | Adenosine deaminase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Hairy cell leukemia
Boxed warnings
- WARNING NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified (see DOSAGE AND ADMINISTRATION ) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m 2 in divided doses over 5 days) than recommended. In a clinical investigation in patients with refractory chronic lymphocytic leukemia using NIPENT at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of NIPENT in combination with fludarabine phosphate is not recommended.
Common side effects
- Nausea and/or Vomiting
- Fever
- Rash
- Fatigue
- Leukopenia
- Pruritus
- Coughing/Increased Cough
- Myalgia
- Chills
- Headache
- Diarrhea
- Abdominal Pain
Key clinical trials
- Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma (PHASE2)
- Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation (PHASE2)
- A Blood Stem Cell Transplant for Sickle Cell Disease (PHASE1)
- Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ... (PHASE1,PHASE2)
- A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-thymocyte Globulin) Followed by Haploidentical Hematopoietic Stem Cell Transplant for the Treatment of Patients With Refractory or Recurrent Severe Aplastic Anemia (PHASE1)
- A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nipent CI brief — competitive landscape report
- Nipent updates RSS · CI watch RSS
- Hospira Inc portfolio CI