Classes
DEA Class; Rx
Common Brand Names; Leustatin DSC, Mavenclad
- Antineoplastics, Antimetabolite
Description
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
Indications
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.
Contraindications
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
Adverse Effects
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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Cladribine
injectable solution (generic formulation)
- 1mg/mL (10 mL single-use vial)
tablets
- 10mg (Mavenclad)
