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Hairy Cell Leukemia
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Leustatin

cladribine
Purine Analog FDA Approved 1993 Janssen
Route
IV
Half-Life
~5.4 hrs
FDA Approved
1993
Manufacturer
Janssen
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1. Indications and Usage

Active hairy cell leukemia.

2. Dosage and Administration

0.09 mg/kg/day CIV x7 days.

3. Dosage Forms and Strengths

10 mg/10 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Myelosuppression: Severe.
  • Immunosuppression: Lymphopenia.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Neutropenia (70%), Fever (69%), Fatigue (45%), Nausea (28%), Infection (28%), Rash (27%)

Neutropenia
70%
Fever
69%
Fatigue
45%
Nausea
28%
Infection
28%
Rash
27%

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

7. Drug Interactions

Additive myelosuppression.

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

Purine analog causing DNA strand breaks in lymphocytes.

Pharmacokinetics

t1/2: 5.4h.

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 Leustatin Trials on ClinicalTrials.gov ↗ 📚 PubMed: Leustatin Clinical Trials ↗
FDA-Approved Tumor Types

Leustatin 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 Leustatin. 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 Leustatin (cladribine) approved for?

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

How is Leustatin (cladribine) administered?

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

How does Leustatin (cladribine) work?

Purine analog causing DNA strand breaks in lymphocytes.

What are the most common side effects?

Neutropenia (70%), Fever (69%), Fatigue (45%), Nausea (28%), Infection (28%), Rash (27%) Neutropenia 70% Fever 69% Fatigue 45% Nausea 28% Infection 28% Rash 27%

← All Therapies Full Prescribing Information ↗