Prescription medicine
Pentostatin Brand names: Nipent
Pentostatin (Nipent) is a prescription medicine with an FDA approval on record since 1991. No generic is listed in FDA's NDC Directory.
- No generic listed
- In shortage
- Boxed warning
Check it at the source: the pentostatin FDA label on DailyMed (effective July 1, 2026, Hospira, Inc.); the NDA 20122 record on Drugs@FDA; every pentostatin label on DailyMed.
Highlights of the record
FDA label of July 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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.
Used for
From the label: indications and usageNIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Forms and strengths
- 2 mg/ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- October 11, 1991 Nipent, Hospira Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first August 7, 2007; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 1 of 1 presentation limited or unavailable updated August 27, 2026
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,048 through July 30, 2026
What is pentostatin used for?
From the label: indications and usageNIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Conditions named in the indications of pentostatin's FDA labels, with every medicine labeled for each:
From other pentostatin labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia …
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Nipent), Hospira, Inc., effective July 1, 2026 (SPL set 674e0e6d-46ed-4868-9196-04019d667716), via openFDA; the full label on DailyMed
Is there a generic for pentostatin (Nipent)?
The FDA approved the first generic pentostatin on August 7, 2007. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1991 earliest approval on file
- 2007 first generic approved
- 2026 to now in shortage
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is pentostatin in shortage?
The FDA Drug Shortage Database lists 1 of 1 pentostatin presentations as limited or unavailable (updated August 27, 2026); the first entry was posted on August 27, 2026.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Nipent, Injection, 10 mg, single dose vial (NDC 0409-0801-01) | Hospira, Inc., a Pfizer Company | Current | August 27, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the pentostatin label say about other medicines?
The pentostatin label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name pentostatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Allopurinol | drug interactions | Drug Interactions Allopurinol and NIPENT are both associated with skin rashes. |
| Carmustine | drug interactions | Acute pulmonary edema and hypotension, leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of the ablative regimen for bone marrow transplant. |
| Cyclophosphamide | drug interactions | Acute pulmonary edema and hypotension, leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of the ablative regimen for bone marrow transplant. |
| Etoposide | drug interactions | Acute pulmonary edema and hypotension, leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of the ablative regimen for bone marrow transplant. |
| Fludarabine | boxed warning | 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. |
Other labels that name pentostatin
Source: FDA drug label (Nipent), Hospira, Inc., effective July 1, 2026 (SPL set 674e0e6d-46ed-4868-9196-04019d667716), via openFDA; the full label on DailyMed
What do FAERS reports show for pentostatin?
The FDA Adverse Event Reporting System holds 1,048 reports that list pentostatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 255 are coded as a death and 429 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pentostatin?
36 other medicines are given the same way (intravenous) and in the same FDA class as pentostatin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
| Fludarabine | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Cytarabine | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Cytarabine and daunorubicin | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as pentostatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pentostatin
- 36 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Pentostatin side effects
- the label's list beside FAERS reports
- Pentostatin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other