Leustatin (cladribine)

No dosing information is available for this tab.

Administer cladribine by continuous IV infusion as a single course of therapy given over 7 consecutive days. Cladribine injection concentrate must be diluted prior to IV infusion. The drug also has been administered subcutaneously+.

To dilute the drug, add the calculated single daily dose of cladribine injection concentrate through a sterile 0.22-mcm disposable hydrophilic syringe filter to an infusion bag containing 500 mL of 0.9% sodium chloride injection. Repeat daily for a total of 7 consecutive days. Admixtures of cladribine injection are chemically and physically stable for at least 24 hours at room temperature under normal room fluorescent light in Baxter Viaflex PVC infusion containers. Do not use dextrose 5% injection because cladribine degradation is accelerated in this diluent. Infuse diluted solution by continuous IV infusion over 24 hours.

Alternatively, if the entire 7-day course of cladribine is to be administered as a single continuous IV infusion, the manufacturer recommends that the entire dose for this period onlybe diluted with bacteriostatic 0.9% sodium chloride injection containing benzyl alcohol as a preservative. To further minimize the risk of microbial contamination, first the calculated 7-day dose of cladribine concentrate for injection (0.63 mg/kg total) and then the calculated amount of diluent needed to bring the total volume of the solution to 100 mL should be passed through a sterile 0.22-mcm disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. Solutions of cladribine prepared with bacteriostatic sodium chloride injection for individuals weighing more than 85 kg may have reduced preservative effectiveness because of greater dilution of the benzyl alcohol. Admixtures for the 7-day infusion have demonstrated acceptable chemical and physical stability for at least 7 days in the SIMS Deltec Medication Cassette Reservoir. Infuse diluted solution continuously over 7 days.

Cladribine IV infusion solutions that have been prepared with bacteriostatic sodium chloride injection containing benzyl alcohol should not be used in neonates.

Consult the manufacturer's labeling for additional information on proper techniques for dilution, storage, and administration of cladribine as well as measures to avoid precipitation of the drug.

Store cladribine injection in the refrigerator at 2-8oC, protected from light until time of use. Once diluted, administer solutions of cladribine injection promptly or store at 2-8oC for no more than 8 hours before the start of administration.

No dosing information is available for this tab.

No dosing information is available for this tab.

There are no known drug interactions with cladribine.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to the drug or any of its components.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most frequent adverse effects of cladribine include pyrexia (33%), fatigue (31%), nausea (22%), rash (16%), and headache (14%).

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of cladribine in children have not been established. When cladribine was administered by continuous IV infusion at dosages of 3-10.7 mg/m2 daily for 5 days in patients 1-21 years of age with relapsed acute leukemia, the dose-limiting toxicity was severe myelosuppression with profound neutropenia and thrombocytopenia. At the highest dosage, several patients developed irreversible myelosuppression and fatal systemic bacterial or fungal infections. No unique toxicities were reported in these patients. Children may tolerate cladribine better than adults.

Cladribine IV infusion solutions that have been prepared with bacteriostatic sodium chloride injection containing benzyl alcohol should not be used in neonates. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates.

Cladribine can cause fetal harm when administered to pregnant females. Although there is no evidence of teratogenicity in humans caused by cladribine, other drugs that inhibit DNA synthesis (e.g., methotrexate, aminopterin) have been reported to be teratogenic in humans, and cladribine has been shown to be teratogenic in mice and rabbits.

Cladribine should not be used during pregnancy. If the drug is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus. (See Females and Males of Reproductive Potential under Cautions.)

It is not known whether cladribine is distributed into human milk. Because of the potential for serious adverse reactions to cladribine in nursing infants if the drug were distributed into milk, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the patient.

While other clinical experience has not revealed age-related differences in response, drug dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered.

Clinical studies of cladribine did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. While other clinical experience has not revealed age-related differences in response, drug dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered.