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Cladribine

    Brands

    DEA Class; Rx

    Common Brand Names; Leustatin DSC, Mavenclad

    • Antineoplastics, Antimetabolite

    Parenteral and oral, synthetic purine nucleoside antimetabolite
    Used for various lymphomas and leukemias and relapsing forms of multiple sclerosis
    Associated with serious, generally dose-dependent and reversible, bone marrow suppression and increased risk of infection

    Indicated for the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting disease and active secondary progressive disease.

    For the treatment of active hairy-cell leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.

    For induction therapy of previously untreated acute myelogenous leukemia (AML), in combination with daunorubicin and cytarabine.

    Cladribine (parenteral)

    • Hypersensitivity

    Mavenclad

    • Patients with current malignancy

    • Pregnant women and women and men of reproductive potential who do not plan to use effective contraception during therapy and for 6 months after last dose in each treatment course

    • Patients with infected HIV

    • Active chronic infections (eg, hepatitis, tuberculosis)

    • History of hypersensitivity to drug or excipients

    • Women intending to breastfeed on a treatment day and for 10 days after last dose

    Cladribine (parenteral)

    • Fever (69%)

    • Fatigue (45%)

    • Nausea (28%)

    • Rash (27%)

    • Headache (22%)

    • Appetite decreased (17%)

    • Vomiting (13%)

    Mavenclad

    • Upper respiratory tract infection (38%)

    • Headache (25%)

    • Lymphopenia (24%)

    • Nausea (10%)

    • Hypersensitivity (11%)

    Cladribine (parenteral)

    • As with other potent chemotherapeutic agents, monitoring of renal and hepatic function is also recommended, especially in patients with underlying kidney or liver dysfunction

    • Allopurinol and IV hydration recommended for patients with high tumor burden to prevent tumor lysis syndrome

    • May impair fertility; shown to suppress rapidly generating cells, including testicular cells

    • Fever with or without neutropenia is frequently observed during first month of treatment; given known myelosuppressive effects of therapy, practitioners should carefully evaluate risks and benefits of administering this drug to patients with active infections

    • Nephrotoxicity reported with high doses (4-9 times approved dose), especially when coadministered with other nephrotoxic drugs; manufacturer reports no nephrotoxicity at doses approved for hairy cell leukemia

    • Periodic assessment of peripheral blood counts, particularly during first 4-8 weeks post-treatment, recommended to detect development of anemia, neutropenia and thrombocytopenia and for early detection of any potential sequelae (eg, infection or bleeding)

    Mavenclad

    • Treatment may increase risk of malignancies, including metastatic pancreatic carcinoma, malignant melanoma, and ovarian cancer

    • In clinical studies at dosages similar to or higher than approved dosage, serious cases of thrombocytopenia, neutropenia, and pancytopenia (some with documented bone marrow hypoplasia) requiring transfusion and granulocyte-colony stimulating factor treatment reported; obtain complete blood count (CBC) with differential including lymphocyte count prior to, during, and after treatment

    • Advise women of potential risk to a fetus during therapy and for 6 months after last dose in each treatment course

    • Exclude HIV infection, active tuberculosis, and active hepatitis before initiation of each treatment course

    • Latent tuberculosis infections may be activated with therapy; in patients with tuberculosis infection, delay initiation of treatment until infection adequately treated

    Contraindicated in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception; there are no adequate data on the developmental risk associated with therapy in pregnant women

    There are no data on presence of cladribine in human milk, effects on breastfed infant, or on milk production

    Adults

    0.09 mg/kg/day continuous IV for hairy-cell leukemia; 20 mg (2 tablets)/cycle day PO and 1.75 mg/kg PO per course for 2 courses up to cumulative 3.5 mg/kg PO in 2 years for multiple sclerosis.

    Geriatric

    0.09 mg/kg/day continuous IV for hairy-cell leukemia; 20 mg (2 tablets)/cycle day PO and 1.75 mg/kg PO per course for 2 courses up to cumulative 3.5 mg/kg PO in 2 years for multiple sclerosis.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Cladribine 

    injectable solution (generic formulation)

    • 1mg/mL (10 mL single-use vial)

    tablets

    • 10mg (Mavenclad)