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Hairy Cell Leukemia
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Nipent

pentostatin
Purine Analog FDA Approved 1991 Pfizer
Route
IV
Half-Life
5.7 hrs
FDA Approved
1991
Manufacturer
Pfizer
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1. Indications and Usage

Hairy cell leukemia.

2. Dosage and Administration

4 mg/m2 IV Q2W.

3. Dosage Forms and Strengths

10 mg powder/vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Myelosuppression: Severe.
  • Immunosuppression: Lymphopenia.
  • Renal Toxicity: Hydrate.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (53%), Fever (46%), Infection (36%), Fatigue (29%), Rash (26%), Hepatic Dysfunction (19%)

Nausea
53%
Fever
46%
Infection
36%
Fatigue
29%
Rash
26%
Hepatic Dysfunction
19%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Avoid fludarabine.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

ADA inhibitor causing dATP accumulation.

Pharmacokinetics

t1/2: ~6h. Renal.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Nipent Trials on ClinicalTrials.gov ↗ 📚 PubMed: Nipent Clinical Trials ↗
FDA-Approved Tumor Types

Nipent has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Hairy Cell Leukemia
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Nipent. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Nipent (pentostatin) approved for?

Nipent (pentostatin) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Nipent (pentostatin) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Nipent (pentostatin) work?

ADA inhibitor causing dATP accumulation.

What are the most common side effects?

Nausea (53%), Fever (46%), Infection (36%), Fatigue (29%), Rash (26%), Hepatic Dysfunction (19%) Nausea 53% Fever 46% Infection 36% Fatigue 29% Rash 26% Hepatic Dysfunction 19%

← All Therapies Full Prescribing Information ↗