LITAK 10 mg/5 mL (Cladribine)

Solution for Subcutaneous Injection or Intravenous Infusion — 5 Vials

Therapeutic Category: Antineoplastic Agent | Purine Nucleoside Analogue | Cytotoxic Chemotherapy

Active Ingredient: Cladribine

Strength: 10 mg/5 mL per vial (2 mg/mL)

Dosage Form: Sterile solution for injection

Pack Size: 5 vials

Medical Description

LITAK is a prescription antineoplastic medicine containing cladribine, a purine nucleoside analogue used primarily in the treatment of hairy cell leukemia (HCL), a rare type of blood cancer characterized by the abnormal accumulation of B lymphocytes in the bone marrow, blood, and spleen.

Cladribine interferes with DNA synthesis and repair, leading to the disruption of cellular function and the death of susceptible malignant lymphocytes. This action helps reduce the abnormal accumulation of cancerous cells and can induce remission in patients with hairy cell leukemia.

LITAK is supplied as a sterile solution containing 10 mg of cladribine in 5 mL per vial. Depending on the applicable product information and prescribed treatment protocol, it may be administered by subcutaneous injection or diluted for intravenous infusion under the supervision of an experienced oncology or hematology specialist.

Indications and Potential Benefits

LITAK is indicated for the treatment of hairy cell leukemia in adults.

Potential clinical benefits include:

• Reduction of malignant lymphocytes: Helps eliminate abnormal B lymphocytes responsible for the disease.
• Induction of remission: May produce complete or partial remission in appropriately selected patients.
• Improvement in blood cell counts: Successful treatment may help improve anemia, neutropenia, and thrombocytopenia associated with bone marrow involvement.
• Reduction of disease-related symptoms: May help alleviate symptoms associated with the disease, such as fatigue, recurrent infections, and an enlarged spleen.

Some national product information also includes second-line treatment of lymphoplasmacytic lymphoma (Waldenström macroglobulinemia) after failure of alkylating agents. This additional indication should be confirmed against the locally approved product information.

Mechanism of Action

Cladribine is a purine nucleoside analogue that interferes with DNA synthesis and repair.

After entering susceptible cells, it is converted into an active phosphorylated metabolite that accumulates particularly in lymphocytes and other hematopoietic cells. This metabolite disrupts DNA synthesis, inhibits DNA repair, and promotes cell death.

These cytotoxic effects reduce abnormal lymphocyte populations involved in hairy cell leukemia. However, normal blood and immune cells may also be affected, resulting in bone marrow suppression and an increased risk of infection.

Dosage and Administration

LITAK must be administered according to a specialist-prescribed chemotherapy protocol.

For hairy cell leukemia, the usual labeled regimen for the subcutaneous route is:

• Recommended dose: 0.14 mg/kg of body weight once daily.
• Treatment duration: Five consecutive days, generally as a single treatment course.
• Subcutaneous administration: The ready-to-use solution is administered by subcutaneous injection without dilution.
• Intravenous infusion: If permitted by the applicable product information and prescribed protocol, the calculated dose may be diluted in 0.9% sodium chloride solution and administered by infusion under appropriate clinical supervision.

The exact preparation, route, infusion conditions, and monitoring requirements must follow the relevant product information and institutional chemotherapy procedures. Do not use the vial strength alone to determine an individual patient's dose.

Possible Side Effects

Common and clinically important adverse effects include:

• Neutropenia and other reductions in white blood cell counts.
• Anemia and thrombocytopenia.
• Lymphopenia and immunosuppression.
• Fever, chills, and fatigue.
• Nausea, vomiting, diarrhea, and decreased appetite.
• Skin rash and injection-site reactions.
• Headache and dizziness.
• Changes in liver function tests.

Serious risks include:

• Severe or opportunistic infections, including pneumonia and sepsis.
• Significant bone marrow suppression, potentially requiring transfusion or other supportive care.
• Prolonged immune suppression.
• Kidney or liver toxicity.
• Tumor lysis syndrome in susceptible patients.
• Rare neurological complications, including progressive multifocal leukoencephalopathy (PML).
• Possible secondary malignancies following treatment.

Fever during or after treatment requires prompt medical assessment because it may indicate a serious infection in an immunocompromised patient.

Warnings and Precautions

• Blood counts: Complete blood counts should be monitored closely during treatment and throughout recovery.
• Infection risk: Assess for active infections before starting therapy. Report fever or other signs of infection immediately.
• Kidney and liver function: Evaluate renal and hepatic function before and during treatment as clinically indicated.
• Pregnancy and breastfeeding: LITAK is contraindicated during pregnancy and lactation under the referenced product information. Appropriate contraception and reproductive counseling are essential.
• Drug interactions: Concomitant use with other myelosuppressive medicines may increase toxicity. The treating specialist must review all medications.
• Neurological monitoring: New or worsening neurological or cognitive symptoms require urgent assessment.
• Tumor lysis syndrome: Patients with a high tumor burden may require preventive measures, including hydration and uric-acid management.
• Handling precautions: Cladribine is a cytotoxic medicine. Preparation, administration, and disposal must follow hazardous-drug handling procedures. Pregnant personnel should avoid handling the product.

LITAK is contraindicated in patients with moderate to severe renal impairment or moderate to severe hepatic impairment under the cited European product information. The approved local prescribing information must be consulted for all contraindications.

Storage

• Store refrigerated at 2–8°C, according to the referenced product information.
• Do not freeze.
• Protect the product from damage and contamination.
• Inspect the solution before use; do not use a damaged vial or a solution containing particles or discoloration.
• The vial is intended for single use. Discard any unused residue according to cytotoxic waste-disposal procedures.
• Keep out of the reach of children.

Always follow the storage and preparation instructions on the locally supplied product packaging.

References

1. European Medicines Agency (EMA) — .eu: LITAK European Public Assessment Report, including approved indication, clinical use, and product information. Read EMA product information.
2. Electronic Medicines Compendium — .org.uk: LITAK Summary of Product Characteristics, including composition, dosage, contraindications, adverse effects, and pharmacology. Read the professional prescribing information.
3. Australian Commission on Safety and Quality in Health Care — .gov.au: LITAK medicine information, composition, administration, and handling precautions. Read Australian medicine information.
4. Therapeutic Goods Administration (TGA) — .gov.au: Australian Register of Therapeutic Goods entry for LITAK 10 mg/5 mL injection. View official registration details.

Patient Disclaimer

This information is intended for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. LITAK (cladribine) is a potent prescription chemotherapy medicine that must be prescribed and administered under the supervision of a qualified hematologist or oncologist. Treatment requires careful laboratory monitoring and assessment of infection risk, blood counts, and organ function. Do not use, prepare, or administer this medicine without appropriate professional supervision. Always consult your healthcare team and refer to the approved product leaflet for complete instructions and safety information.