Pentostatin: uses, dosing, side effects & brands
Pentostatin is a medicine sold in the U.S. under one brand, for hairy cell leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Hairy Cell Leukemia
- Available as
- Injectable
- Sold as
- Nipent
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How pentostatin is dosed
From the FDA label for Nipent (application NDA020122). Other pentostatin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
It is recommended that patients receive hydration with 500 to 1,000 mL of 5% Dextrose in 0.5 Normal Saline or equivalent before NIPENT administration. An additional 500 mL of 5% Dextrose or equivalent should be administered after NIPENT is given. The recommended dosage of NIPENT for the treatment of hairy cell leukemia is 4 mg/m 2 every other week. NIPENT may be administered intravenously by bolus injection or diluted in a larger volume and given over 20 to 30 minutes (See Preparation of Intravenous Solution ). Higher doses are not recommended. No extravasation injuries were reported in clinical studies. The optimal duration of treatment has not been determined. In the absence of major toxicity and with observed continuing improvement, the patient should be treated until a complete response has been achieved. Although not established as required, the administration of two additional doses has been recommended following the achievement of a complete response. All patients receiving NIPENT at 6 months should be assessed for response to treatment. If the patient has not achieved a complete or partial response, treatment with NIPENT should be discontinued. If the patient has achieved a partial response, NIPENT treatment should be continued in an effort to achieve a complete response. At any time thereafter that a complete response is achieved, two additional doses of NIPENT are…
Pentostatin side effects
Most patients treated for hairy cell leukemia in the five NCI-sponsored Phase 2 studies and the Phase 3 SWOG study experienced an adverse event. The following table lists the most frequently occurring adverse events in patients treated with NIPENT (both frontline and IFN-refractory patients) compared with IFN (frontline only), regardless of drug association. The drug association of some adverse events is uncertain as they may be associated with the disease itself (e.g., infection, hematologic suppression), but other events, such as the gastrointestinal symptoms, rashes, and abnormal liver function tests, can in many cases be attributed to the drug. Most adverse events that were assessed for severity were either mild or moderate, and diminished in frequency with continued therapy. NR = Not Reported Percent of Patients All Adverse Events Occurring in more than 10% of patients, in any group, regardless of drug association Frontline, Treated With NIPENT N=180 Frontline, Treated With IFN N=176 IFN-Refractory, Treated With NIPENT N=197 Nausea and/or Vomiting 63 22 53 Includes only nausea with vomiting Fever 46 59 42 Rash 43 30 26 Fatigue 42 55 29 Leukopenia 22 15 60 Pruritus 21 6 10 Coughing/Increased Cough 20 15 17 Myalgia 19 36 11 Chills 19 34 11 Headache 17 29 13 Diarrhea 17 17 15 Abdominal Pain 16 15 4 Anorexia 13 10 16 Upper Respiratory Infection 13 8 16 Asthenia 12 13 10…
Who shouldn’t take pentostatin
NIPENT is contraindicated: In patients who have demonstrated hypersensitivity to NIPENT.
Pentostatin drug interactions
Allopurinol and NIPENT are both associated with skin rashes. Based on clinical studies in 25 refractory patients who received both NIPENT and allopurinol, the combined use of NIPENT and allopurinol did not appear to produce a higher incidence of skin rashes than observed with NIPENT alone. There has been a report of one patient who received both drugs and experienced a hypersensitivity vasculitis that resulted in death. It was unclear whether this adverse event and subsequent death resulted from the drug combination. Biochemical studies have demonstrated that pentostatin enhances the effects of vidarabine, a purine nucleoside with antiviral activity. The combined use of vidarabine and NIPENT may result in an increase in adverse reactions associated with each drug. The therapeutic benefit of the drug combination has not been established. The combined use of NIPENT and fludarabine phosphate is not recommended because it may be associated with an increased risk of fatal pulmonary toxicity (see WARNINGS ). 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.
Every pentostatin product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Nipent.
What people report to the FDA about pentostatin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 841 reports naming pentostatin, and the FDA flagged 91% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- neutropenia76 reports
- pyrexia60 reports
- diarrhoea52 reports
- dyspnoea51 reports
- pneumonia49 reports
- thrombocytopenia49 reports
- anaemia47 reports
- sepsis45 reports
Read these as a signal, not a rate. A report does not mean pentostatin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is pentostatin?
Nipent (Pentostatin) is a medication used to treat Hairy Cell Leukemia.
Can you take pentostatin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pentostatin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does pentostatin come in?
Across the brands we track, pentostatin is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pentostatin?
We do not currently list a generic-labelled pentostatin product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pentostatin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pentostatin
- MLA
- “Pentostatin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pentostatin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pentostatin on DailyMed (NIH) ↗ — including its boxed warning in full.