NIPENT (Pentostatin)

NIPENT (pentostatin for injection) is a chemotherapy medicine for hairy cell leukaemia, a rare, slow-growing B-cell blood cancer. The US label approves it as a single agent for adults who have not been treated before and for those whose disease did not respond to alpha-interferon, when the leukaemia is active: that is, when it is causing significant anaemia, low neutrophil or platelet counts, or symptoms.

Pentostatin, also called 2′-deoxycoformycin, comes from cultures of the bacterium Streptomyces antibioticus. It strongly blocks adenosine deaminase, an enzyme that is most active in lymphoid cells. With the enzyme blocked, a breakdown product (dATP) builds up inside these cells and stops them from making DNA. The label notes that the exact way it works against hairy cell leukaemia is still not fully known.

The main evidence comes from the SWOG 8691 study in previously untreated patients. Among evaluable patients, 84% had a complete response with NIPENT compared with 18% on interferon, and blood counts recovered faster: neutrophils in a median of 70 days versus 106 days. In patients who had already failed interferon, complete responses were seen in 58% to 85%, depending on the study group.

NIPENT is one of several options a haematologist may consider for hairy cell leukaemia. For relapsed disease after other treatments, we also help patients obtain moxetumomab pasudotox.

• Boxed warning on dose: doses higher than 4 mg/m² every other week are not recommended. In early studies, 20–50 mg/m² over 5 days caused severe and sometimes fatal kidney, liver, lung and nervous-system toxicity.
• Never combine with fludarabine. In a study in chronic lymphocytic leukaemia, 4 of 6 patients given both drugs developed severe or fatal lung toxicity. Fatal lung swelling and low blood pressure have also been reported when pentostatin was used with carmustine, etoposide and high-dose cyclophosphamide before a bone marrow transplant.
• Low blood counts and infection: neutrophil counts can fall further during the first few courses, so blood counts are checked before every dose. Any active infection should be controlled first; in the main study, herpes zoster (shingles) was reported in 8% of patients on NIPENT compared with 1% on interferon.
• Kidneys: serum creatinine is checked before each dose. Pentostatin is cleared mainly in urine, and its half-life rose from about 6 hours to 18 hours in two patients with poor kidney function. The label gives no set dose when creatinine clearance is below 60 mL/min.
• Rashes, sometimes severe, are common and may need the treatment to be paused. Treatment should be stopped or withheld if there are signs of nervous-system toxicity.
• Most frequent side effects in untreated patients: nausea or vomiting (63%), fever (46%), rash (43%), tiredness (42%), low white cell count (22%) and itching (21%).
• It can harm an unborn baby. Women should use effective contraception during treatment and for 6 months after the last dose, men with a female partner for 3 months, and breastfeeding should stop during treatment and for 1 week after. It is not approved for children.

How many vials does a course usually need?

Each vial holds 10 mg. The label dose is 4 mg per square metre of body surface every second week, so most adults need one vial per dose; a large adult may need two. Patients are reviewed at 6 months. If the leukaemia is in complete remission, two more doses are usually given and treatment stops; it should not run beyond 12 months. Your haematologist calculates the exact number of vials.

Which papers are needed for an import order?

• Prescription from the treating haematologist or oncologist, with the dose in mg and the number of cycles
• Diagnosis report confirming hairy cell leukaemia (blood film, flow cytometry or bone marrow report)
• Patient’s ID proof and the address of the hospital or day-care unit where the infusion will be given

The vials are supplied for one named patient against these documents only.

How is the vial stored and given?

Unopened vials are kept in a refrigerator at 2–8 °C, so they travel in cold-chain packing. The powder is dissolved in 5 mL of sterile water and given into a vein, either as a quick injection or diluted and run over 20–30 minutes, with intravenous fluids before and after. Once mixed it has no preservative and must be used within 8 hours. It is a hazardous drug, so a hospital chemotherapy pharmacy should prepare it.

Is NIPENT sold in India?

We could not find a CDSCO marketing approval or any pentostatin product on Indian pharmacy listings (checked November 2026). Interestingly, the FDA label file lists an Indian company, Zydus Hospira Oncology Private Limited, as a manufacturing site, but the product is made for overseas markets. Patients in India therefore obtain it by named patient import.

Pentostatin is an old drug made by very few companies, and supply has been interrupted before. In 2022 Pfizer told US prescribers that a delay at its active-ingredient supplier was likely to cause a stock-out, with full supply expected back by the end of March 2023. We therefore check stock and the expiry date with our supplier before confirming an order. Vials come in their original cartons from licensed distributors in the USA or Europe and are shipped at 2–8 °C.

For NIPENT price in India and delivery time, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, toll-free 1800 1200 365, or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA approval on 11 October 1991 (NDA 020122, Hospira). Still marketed; label last revised November 2025.
• Ireland: national licence PA0822/228/001 since April 1993, held by Pfizer Healthcare Ireland.
• United Kingdom: licensed; the current product information (December 2025) is issued by Hospira UK Ltd for adults with hairy cell leukaemia.
• European Union: no EU-wide (EMA) approval; it is licensed country by country.
• India: no CDSCO approval found.

Sources:

• NIPENT US Prescribing Information, DailyMed (revised 11/2025)
• Drugs@FDA: NDA 020122
• HPRA Ireland: NIPENT 10 mg licence details
• UK Summary of Product Characteristics (eMC)
• Pfizer letter on NIPENT supply (hosted by FDA)

Information last checked: November 2026.

What is NIPENT used for?

Treating active hairy cell leukaemia in adults, either as the first treatment or after alpha-interferon has failed.

How does pentostatin work?

It blocks adenosine deaminase, an enzyme that lymphoid cells depend on. The build-up of dATP that follows stops the leukaemia cells from making DNA.

How often is NIPENT given?

Once every two weeks as an intravenous injection or short infusion, usually for several months until the best response is reached.

Can NIPENT be given with fludarabine?

No. The label advises against this combination because it was linked with severe and fatal lung toxicity.

Who makes NIPENT?

Hospira, Inc., part of Pfizer, distributes it in the USA; Pfizer and Hospira hold the licences in Ireland and the UK.

Is NIPENT approved by the FDA?

Yes, since 1991, and it is still on the US market.