Product image of Leuject (Cladribine) supplied by GNH India

Leuject

Active Ingredient:
Cladribine
Origin:
EU

Leuject (Cladribine)

Cladribine, the active ingredient in Leuject, is a purine nucleoside analog presented as a sterile solution for subcutaneous administration. It selectively depletes lymphocytes by incorporating into DNA, and is indicated for the treatment of hairy cell leukemia and for disease‑modifying therapy of multiple sclerosis in adult patients.

GNH India supplies Leuject as a licensed, Good Distribution Practice‑compliant product sourced from the European Union, providing reliable supply to hospitals, oncology centres, pharmacies and clinics worldwide while meeting all applicable regulatory standards and supporting patient care.

Manufacturer / TM Owner

Atnahs Pharma Netherlands B.V.

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Indications & Clinical Uses

  • Cladribine is employed in the management of hematologic malignancies and neuro‑inflammatory disease.
  • Hairy cell leukemia: Cladribine induces durable remission by selectively incorporating into the DNA of malignant B‑lymphocytes, leading to apoptosis and depletion of the leukemic clone.
  • Multiple sclerosis: The drug acts as an immunomodulatory agent that reduces the frequency of clinical relapses and slows accumulation of disability by depleting pathogenic lymphocytes involved in central nervous system inflammation.

How It Works

  • Cladribine is phosphorylated intracellularly to its active triphosphate form, which is incorporated into DNA during replication. This incorporation triggers DNA strand breaks and inhibits repair, leading to apoptosis of proliferating lymphocytes while sparing non‑dividing cells, resulting in selective lymphocyte depletion.

Side Effects

Cladribine may cause a range of adverse reactions.

Common Side Effects

  • Injection site pain or erythema
  • Nausea or vomiting
  • Fatigue or general weakness
  • Transient fever or flu‑like symptoms
  • Mild lymphopenia
  • Headache

Serious or Rare Side Effects

  • Severe or opportunistic infections
  • Profound lymphopenia increasing infection risk
  • Autoimmune hepatitis or liver dysfunction
  • Secondary malignancies
  • Anaphylactic reactions
  • Severe cutaneous adverse reactions (e.g., Stevens‑Johnson syndrome)

Precautions & Warnings

  • Patients receiving Cladribine should be monitored closely for safety.
  • Monitor blood counts: regular CBC to detect lymphopenia.
  • Assess infection risk: screen for active infections before initiation.
  • Evaluate organ function: check renal and hepatic parameters.
  • Avoid use in pregnancy: only if benefits outweigh risks.
  • Discontinue if severe infection occurs.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Cladribine may interact with other medicines; awareness of interaction severity is important.

Major Interactions (Avoid)

  • Live attenuated vaccines: risk of uncontrolled infection.
  • Concurrent cytotoxic chemotherapy: additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Strong immunosuppressants (e.g., azathioprine): may enhance lymphocyte depletion.
  • Antifungal agents metabolized by CYP enzymes: potential altered drug levels.
  • NSAIDs: may increase risk of gastrointestinal irritation.

Frequently Asked Questions

Leuject contains the active ingredient cladribine and is approved for the treatment of hairy cell leukemia, a rare B‑cell malignancy, as well as for disease‑modifying therapy of multiple sclerosis in adult patients. In both indications it works by selectively depleting pathogenic lymphocytes.

Cladribine is taken up by lymphocytes and phosphorylated to an active triphosphate that is incorporated into DNA. This incorporation causes DNA strand breaks and blocks repair, leading to apoptosis of rapidly dividing lymphocytes while sparing most other cell types, thereby reducing abnormal immune activity.

The dosing regimen for Leuject is determined by the prescribing physician based on the specific indication, patient weight, renal and hepatic function, and other clinical factors. The prescriber will set the dose and schedule according to the approved product labeling.

Safety of cladribine during pregnancy and lactation has not been fully established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss alternatives with their healthcare provider.

To request Leuject, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. 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 if needed) and any required import documentation.

In hairy cell leukemia, cladribine is often preferred over older agents such as pentostatin because of higher remission rates. For multiple sclerosis, cladribine offers an oral‑free, intermittent dosing schedule compared with continuous infusion biologics, but clinicians weigh efficacy, safety profile, and patient preference when selecting therapy.

Leuject must be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking. If the product is inadvertently exposed to temperatures outside this range, it should not be used.

Leuject is supplied as a sterile solution for subcutaneous injection. The injection is performed by a qualified healthcare professional, typically in a clinical setting, using aseptic technique. The dose and frequency are prescribed by the treating physician.

The most serious risks include severe or opportunistic infections due to profound lymphopenia, secondary malignancies, autoimmune hepatitis, and rare hypersensitivity reactions such as anaphylaxis. Patients should be monitored closely for signs of infection and liver dysfunction throughout therapy.

Leuject is contraindicated in patients with active severe infections, known hypersensitivity to cladribine or any excipients, and in pregnant women unless the benefit outweighs the risk. Caution is also advised for individuals with severe immunodeficiency or uncontrolled organ dysfunction.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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