Product image of Leustatin (Cladribine) supplied by GNH India

Leustatin

Active Ingredient:
Cladribine
Origin:
EU

Leustatin (Cladribine)

Cladribine, the active ingredient in Leustatin, is a purine nucleoside analog presented as an intravenous solution for intravenous use. It is employed in the management of multiple sclerosis and hairy cell leukemia, targeting abnormal lymphocytes in adult patients.

GNH India supplies Leustatin as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with rigorous quality assurance and regulatory compliance. Our distribution network ensures timely delivery and supports import documentation for global markets, including cold‑chain logistics where required.

Manufacturer / TM Owner

Atnahs Pharma Netherlands B.V.

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Indications & Clinical Uses

Leustatin (cladribine) is indicated for diseases involving abnormal lymphocyte activity.

  • Multiple sclerosis (relapsing forms): reduces relapse frequency and MRI disease activity in adults.
  • Multiple sclerosis (active disease): slows progression and reduces disability accumulation.
  • Hairy cell leukemia: induces durable remission by depleting malignant B‑cells.

How It Works

  • Cladribine is a purine nucleoside analog that is taken up by lymphocytes via nucleoside transporters. Inside the cell it is phosphorylated to its active triphosphate form, which is incorporated into DNA during replication. This incorporation disrupts DNA synthesis and repair, leading to apoptosis of proliferating lymphocytes, particularly B‑ and T‑cells, thereby providing immunosuppressive and antineoplastic effects. The selective depletion of these cells modulates the immune response and reduces malignant cell burden.

Side Effects

Cladribine may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Lymphopenia: reduced lymphocyte counts.
  • Nausea: mild gastrointestinal upset.
  • Fatigue: general tiredness.

Serious or Rare Side Effects

  • Severe lymphopenia with opportunistic infections.
  • Autoimmune hepatitis or severe liver injury.
  • Serious skin reactions such as Stevens‑Johnson syndrome.

Precautions & Warnings

Before and during treatment with cladribine, several safety measures should be observed.

  • Monitor blood counts: perform regular CBC to detect lymphopenia.
  • Assess infection risk: screen for active infections before initiating therapy.
  • Avoid live vaccines: live attenuated vaccines may cause disease during immunosuppression.
  • Adjust for renal impairment: dose may need modification in patients with reduced renal function.
  • Contraindicated in severe immunodeficiency: do not use in patients with uncontrolled HIV or active malignancies other than the target disease.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Cladribine can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Concurrent use with other myelosuppressive chemotherapy agents: may cause profound bone marrow suppression.
  • Live vaccines: increased risk of vaccine‑derived infection.
  • Strong immunosuppressive biologics: additive immunosuppression may lead to severe infections.

Moderate Interactions (Monitor Closely)

  • Antiviral prophylaxis agents: monitor for potential dose adjustments.
  • Non‑live vaccines: immune response may be attenuated, requiring efficacy assessment.
  • Renally cleared drugs: monitor renal function to avoid accumulation.

Frequently Asked Questions

Leustatin contains cladribine and is approved for the treatment of multiple sclerosis, particularly relapsing forms, and for hairy cell leukemia. In both indications, the drug works by selectively depleting abnormal lymphocytes, helping to control disease activity and achieve remission.

Cladribine is a purine nucleoside analog that enters lymphocytes via nucleoside transporters. Inside the cell it is phosphorylated to an active triphosphate, which becomes incorporated into DNA during replication. This incorporation disrupts DNA synthesis and repair, triggering apoptosis of proliferating B‑ and T‑cells and providing immunosuppressive and antineoplastic effects.

The dosage of Leustatin is individualized by the prescribing physician based on the specific indication, patient weight, renal function, and overall clinical status. No standard dosing regimen is provided here; the prescriber determines the appropriate dose and schedule.

Safety data for cladribine in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss risks with their healthcare provider before starting therapy.

To order Leustatin, visit the product page on gnhindia.com and submit an enquiry with the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, confirming trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain handling if needed), and import documentation.

Leustatin (cladribine) belongs to the class of purine nucleoside analogs, offering oral or intravenous dosing that targets lymphocyte proliferation. Compared with other disease‑modifying therapies such as fingolimod or dimethyl fumarate, cladribine provides a shorter treatment course but carries a distinct safety profile, including a higher risk of lymphopenia and infections.

Leustatin should be stored at 2‑8 °C (refrigerated). Keep the product in its original packaging, protect it from light, and do not freeze or shake the vial. Proper cold‑chain storage helps maintain drug stability and efficacy.

Leustatin is supplied as an intravenous solution and must be administered by a qualified healthcare professional. The infusion is given over a specified period according to the prescriber’s instructions, typically in a clinical setting where patient monitoring can be performed.

The most serious risks include severe lymphopenia leading to opportunistic infections, autoimmune hepatitis, and serious skin reactions such as Stevens‑Johnson syndrome. Patients should be monitored closely for signs of infection, liver dysfunction, and dermatologic changes throughout treatment.

Leustatin is contraindicated in patients with active severe infections, uncontrolled HIV, severe immunodeficiency, or known hypersensitivity to cladribine or any excipients. It should also be avoided in individuals with significant bone‑marrow failure unrelated to the target disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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