Pentostatin

What it is and how it works

Mechanism class: Nucleic Acid Synthesis Inhibitors

Indications

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, thrombocytopenia, or disease-related symptoms.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION It is recommended that patients receive hydration with 500 to 1,000 mL of 5% Dextrose in 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.

Contraindications

CONTRAINDICATIONS NIPENT is contraindicated: In patients who have demonstrated hypersensitivity to NIPENT.

Warnings and precautions

WARNINGS See Boxed Warning . Patients with hairy cell leukemia may experience myelosuppression primarily during the first few courses of treatment. Patients with infections prior to NIPENT treatment have in some cases developed worsening of their condition leading to death, whereas others have achieved complete response. Patients with infection should be treated only when the potential benefit of treatment justifies the potential risk to the patient. Efforts should be made to control the infection before treatment is initiated or resumed.

Pregnancy

Pregnancy (See WARNINGS )

Storage and supply

HOW SUPPLIED NIPENT (pentostatin for injection) is supplied as a sterile lyophilized white to off-white powder in single-dose vials containing 10 mg of pentostatin. The vials are packed in individual cartons. NDC 0409-0801-01. Storage: Store NIPENT vials under refrigerated storage conditions 2° to 8° C (36° to 46°F).

Source: Pentostatin (Nipent) — US FDA prescribing information, 2026-07-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.