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 a intravenous solution for intravenous use. It treats multiple sclerosis and hairy cell leukemia in appropriate patients.

GNH India supplies Leustatin as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, oncology centres, and pharmacies worldwide.

Manufacturer / TM Owner

Atnahs Pharma Netherlands B.V.

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Indications & Clinical Uses

  • Leustatin (cladribine) is indicated for conditions in which targeted depletion of lymphocytes modifies disease activity.
  • Multiple sclerosis: reduces annualized relapse rate and delays disability progression in adults with active disease.
  • Hairy cell leukemia: produces durable complete remission by selectively depleting malignant B‑lymphocytes.

How It Works

  • Cladribine is a purine nucleoside analog that is phosphorylated inside cells to its active triphosphate form. The metabolite incorporates into DNA during replication, causing strand breaks and inhibiting DNA repair, which leads to selective apoptosis of proliferating B and T lymphocytes, thereby reducing abnormal immune activity and malignant cell populations.

Side Effects

Cladribine may be associated with a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Lymphopenia: a reduction in circulating lymphocytes that may increase infection susceptibility.
  • Infections: mild to moderate upper respiratory or urinary tract infections occurring during treatment.
  • Nausea: transient nausea or vomiting, often manageable with supportive care.

Serious or Rare Side Effects

  • Severe infections: opportunistic infections such as pneumocystis jirovecii pneumonia or herpesvirus reactivation.
  • Autoimmune disorders: emergence of autoimmune hepatitis, thyroiditis, or other organ‑specific autoimmunity.
  • Skin reactions: severe cutaneous adverse reactions including Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

When using cladribine, several precautions should be observed to minimize risks and ensure safe administration.

  • Baseline assessment: obtain complete blood count and lymphocyte subsets before initiating therapy.
  • Infection monitoring: screen for active infections and monitor for signs of opportunistic infection during treatment.
  • Vaccination: avoid live vaccines during and for several weeks after therapy; update inactivated vaccines beforehand.
  • Pregnancy and lactation: contraindicated in pregnancy; advise effective contraception and discuss risks with women of childbearing potential.
  • Renal/hepatic function: adjust use in patients with significant hepatic or renal impairment after clinical evaluation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Cladribine can interact with other medicines, affecting its efficacy or safety profile.

Major Interactions (Avoid)

  • Live vaccines: concurrent administration may cause severe infection.
  • Immunosuppressants: combined use can markedly increase risk of profound lymphopenia and infection.
  • Antiviral prophylaxis: certain antivirals may alter cladribine metabolism (e.g., strong CYP inhibitors).

Moderate Interactions (Monitor Closely)

  • Vaccines (inactivated): may have reduced immunogenicity; assess timing.
  • Anticoagulants: monitor for bleeding if thrombocytopenia develops.
  • Hormonal contraceptives: efficacy may be reduced; consider additional barrier methods.

Frequently Asked Questions

Leustatin, whose active ingredient is cladribine, is approved for the treatment of adult patients with relapsing forms of multiple sclerosis and for adults with hairy cell leukemia. In multiple sclerosis it helps reduce relapse frequency and slow disability progression, while in hairy cell leukemia it induces remission by targeting malignant B‑lymphocytes.

Cladribine is a purine nucleoside analog that enters cells and is phosphorylated to its active triphosphate form. This metabolite incorporates into DNA during replication, causing strand breaks and preventing DNA repair. The resulting DNA damage triggers apoptosis preferentially in proliferating lymphocytes, leading to selective depletion of B‑ and T‑cells that drive autoimmune activity or malignancy.

The dosing schedule for Leustatin is determined by the prescribing physician based on the specific indication, patient weight, renal and hepatic function, and treatment protocol. Clinicians calculate the appropriate intravenous dose and administration intervals, and the regimen may be adjusted during the course of therapy according to laboratory monitoring and clinical response.

The safety of cladribine in pregnancy and lactation has not been established. It is generally contraindicated in pregnant women because of potential fetal toxicity, and breastfeeding is not recommended during treatment and for a period after the last dose. Women of childbearing potential should use effective contraception throughout therapy and for a defined time afterward.

To request Leustatin, visit the product page on gnhindia.com, enter the desired quantity, and submit the enquiry form. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details—including cold‑chain handling if required—and assistance with import documentation.

Compared with other disease‑modifying therapies for multiple sclerosis, cladribine offers a short‑course oral or intravenous regimen that provides long‑lasting immune modulation after limited dosing cycles. Unlike continuous‑infusion agents, it requires fewer treatment visits, but it carries a distinct safety profile, including lymphopenia and infection risk, which must be weighed against efficacy and patient preference.

Leustatin should be stored in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F). The vial must be kept in its original packaging to protect it from light, and it should never be frozen or shaken. If temperature excursions occur, the product should be inspected for visual changes before use.

Leustatin is supplied as an intravenous solution that is administered by a qualified healthcare professional. The infusion is typically given over a specified period, often ranging from several minutes to an hour, depending on the prescribed dose and clinical protocol. Venous access should be established, and the patient monitored for infusion‑related reactions throughout the administration.

The most serious risks of cladribine therapy include profound lymphopenia leading to opportunistic infections such as pneumocystis jirovecii pneumonia, reactivation of latent viruses, and rare but severe autoimmune disorders like hepatitis or thyroiditis. Additionally, rare cutaneous reactions such as Stevens‑Johnson syndrome and potential secondary malignancies have been reported, requiring vigilant monitoring.

Leustatin is contraindicated in patients with active severe infections, known hypersensitivity to cladribine or any excipients, pregnant or breastfeeding women, and individuals with significant hepatic or renal impairment unless a specialist determines a safe benefit‑risk balance. It should also be avoided in patients receiving live vaccines or other potent immunosuppressive agents without careful clinical oversight.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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