Product image of Leustatin (Cladribine) supplied by GNH India

Leustatin

Active Ingredient:
Cladribine
Origin:
EU

Leustatin (Cladribine)

Cladribine, the active ingredient in Leustatin, is an antimetabolite presented as an injectable solution for intravenous use. It selectively depletes lymphocytes by incorporating into DNA, and is indicated for the treatment of hairy cell leukemia in adult patients.

GNH India supplies Leustatin as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, oncology centres, transplant units and pharmacies worldwide. The product is manufactured in the European Union and meets EU pharmacovigilance requirements.

Manufacturer / TM Owner

Atnahs Pharma Netherlands B.V.

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

  • Leustatin (cladribine) is used in the management of hematologic malignancies that involve abnormal B‑cell proliferation.
  • Hairy cell leukemia: induces remission by depleting malignant B‑cells.

How It Works

  • Cladribine is a purine nucleoside analogue that is phosphorylated intracellularly and incorporated into DNA during replication. This incorporation disrupts DNA synthesis and repair, leading to apoptosis of proliferating lymphocytes while sparing most non‑lymphoid cells, resulting in selective lymphocyte depletion.

Side Effects

Cladribine may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Fatigue: generalized tiredness during treatment.
  • Fever: transient elevations in body temperature.
  • Infections: increased susceptibility to bacterial or viral infections.
  • Lymphopenia: reduced lymphocyte counts.
  • Headache: occasional mild headache.

Serious or Rare Side Effects

  • Severe infections: opportunistic or life‑threatening infections.
  • Autoimmune hemolytic anemia: destruction of red blood cells.
  • Secondary malignancies: rare development of new cancers.
  • Severe neutropenia: markedly low neutrophil counts.
  • Hepatic toxicity: abnormal liver function tests.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.

Precautions & Warnings

  • Cladribine requires careful monitoring and specific safety measures before and during therapy.
  • Monitor blood counts: perform regular complete blood count assessments.
  • Assess infection risk: screen for active infections prior to initiation.
  • Evaluate organ function: check hepatic and renal function before dosing.
  • Avoid concurrent immunosuppressants: limit use of other myelosuppressive agents.
  • Contraception advised: use effective birth control during treatment and for a defined period after.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Cladribine can interact with other medicines, altering efficacy or safety.

Major Interactions (Avoid)

  • Live vaccines: may cause uncontrolled infection.
  • Other cytotoxic chemotherapy: increased myelosuppression risk.
  • Strong immunosuppressants: heightened infection susceptibility.

Moderate Interactions (Monitor Closely)

  • Azole antifungals: may affect drug metabolism.
  • Anticoagulants: monitor for bleeding tendencies.
  • Antihypertensives: observe blood pressure changes.

Frequently Asked Questions

Leustatin contains cladribine, an antimetabolite indicated for the treatment of hairy cell leukemia, a rare B‑cell malignancy. It is administered intravenously to achieve disease control in adult patients.

Cladribine is phosphorylated inside cells and becomes incorporated into DNA. This disrupts DNA synthesis and repair, leading to apoptosis of proliferating lymphocytes and selective depletion of malignant B‑cells.

The dosing regimen for Leustatin is determined by the prescribing physician based on the patient’s clinical condition, body weight, and laboratory parameters. Specific dose and schedule should follow the approved product labeling.

Safety of cladribine in pregnancy and lactation has not been established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and women of child‑bearing potential should use effective contraception.

Enquiries are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and import documentation.

Leustatin (cladribine) is a purine analogue that offers a single‑course, potentially curative approach, whereas alternative regimens such as pentostatin or combination chemo‑immunotherapy may require multiple cycles and have different toxicity profiles.

Leustatin must be stored at 2‑8 °C in a refrigerator, protected from light. Do not freeze the solution, and avoid shaking the vial. Keep it in the original packaging until ready for use.

Leustatin is supplied as a sterile injectable solution for intravenous infusion. Administration is performed by a qualified healthcare professional in a clinical setting, following aseptic technique and the recommended infusion rate.

The most serious risks include severe infections due to profound lymphopenia, opportunistic infections, autoimmune hemolytic anemia, secondary malignancies, and significant hepatic or hematologic toxicity that require close monitoring.

Leustatin is contraindicated in patients with active uncontrolled infections, known hypersensitivity to cladribine or any excipients, and should be used with caution in individuals with severe hepatic or renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Related Products

Other formulations containing Cladribine

A

A
A

A
A

A
A

A

Browse all products →

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Regulatory recognitions

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.

SGS GSDP Certification

GSDP Compliant from SGS

URS ISO 9001

URS ISO 9001 Certification

FDA Maharashtra

Licensed by FDA Maharashtra

IEC License DGFT

IEC License issued by DGFT