LITAK

What it is

LITAK is a solution for injection containing cladribine 10 mg in 5 mL. It is available in single-use vials, ready-to-use for subcutaneous injection without dilution or can be diluted for intravenous infusion. LITAK is a synthetic antineoplastic agent containing cladribine as the active ingredient, a purine nucleoside analogue acting as an antimetabolite.

Approved indications

— Treatment of hairy cell leukaemia. — Second line treatment of lymphoplasmacytic lymphoma (Waldenström's macroglobulinaemia), after failure of alkylating agents.

Dosing overview

Key safety warnings

Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse effects, like myelo- and immunosuppression, long-lasting lymphocytopenia, and opportunistic infections. Patients undergoing treatment with cladribine should be closely monitored for signs of haematologic and non-haematologic toxicities. Cases of progressive multifocal leukoencephalopathy, including fatal cases, have been reported with cladribine, with onset reported 6 months to several years after treatment. Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms. Treatment with cladribine is associated with myelosuppression and profound and prolonged immunosuppression, and treatment with these agents is associated with the occurrence of second malignancies. Patients treated with cladribine should be regularly monitored. Haematological toxicity may be more pronounced with subcutaneous compared to intravenous administration, and during the first month following treatment, myelosuppression is most notable and red blood cell or platelet transfusions may be required. An increased incidence of opportunistic infections is expected during, and for 6 months following, therapy with LITAK. Graft-versus-host disease, including fatal cases, has been reported in patients who have received transfusions of non-irradiated cellular blood components, and patients should receive irradiated cellular blood components to prevent transfusion-related graft-versus-host disease.

Contraindications

LITAK is contraindicated in patients with a history of hypersensitivity to cladribine or any of its excipients. LITAK is also contraindicated during pregnancy and lactation, in patients less than 18 years of age, in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) or moderate to severe hepatic impairment (Child-Pugh score > 6), and in concomitant use of other myelosuppressive medicinal products.

Regulatory history

LITAK cladribine 10 mg/5 mL injection vial was first registered on the ARTG on 1 July 2004.