Dosing and uses of Leustatin (cladribine)
Adult dosage forms and strengths
injectable solution
- 1mg/mL
Hairy Cell Leukemia
0.09 mg/kg/day IV for 7 days continuous infusion; may repeat q28-35Days
Monitor: CBC, chemistries
Orphan Indications
Multiple Sclerosis
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Orphan indications sponsor
- Orphan indication sponsor: Ortho Biotech Oncology Research & Development, Unit of J & J Pharmaceutical Research & Dev., LLC; 920 Route 202 South, P.O. Box 300; Raritan, NJ 08869-0602
Other Indications & Uses
Off-label: Cutaneous T-cell lymphoma, AML, CLL, NHL, autoimmune hemolytic anemia, mycosis fungoides, Sezary syndrome
Pediatric dosage forms and strengths
Safety and efficacy not established
Interactions
>10%
Fever (69%)
Fatigue (45%)
Nausea (28%)
Rash (27%)
HA (22%)
Appetite decreased (17%)
Vomiting (13%)
1-10%
Diarrhea (10%)
Purpura (10%)
Asthenia (9%)
Chills (9%)
Constipation (9%)
Dizziness (9%)
Petechiae (8%)
Insomnia (7%)
Malaise (7%)
SOB (7%)
Abdominal pain (6%)
Edema (6%)
Erythema (6%)
Pruritis (6%)
Warnings
Black box warnings
The drug should be administered under the supervision of an experienced cancer chemotherapy physician
Bone marrow suppression may occur but is usually reversible and appears to be dose dependent
Continuous infusion of high doses of 4 to 9 times the recommended dose for hairy cell leukemia has been associated with serious acute nephrotoxicity and neurological toxicity resulting in irreversible paraparesis and quadraparesis. Standard cladribine dosing regimens have also been associated with severe neurological toxicity
Contraindications
Hypersensitivity
Cautions
Hepatic/renal impairment
Allopurinol and IV hydration recommended for patients with high tumor burden to prevent tumor lysis syndrome
Avoid pregnancy
May impair fertility; shown to suppress rapidly generating cells, including testicular cells
Do not administer live virus vaccines; risk of infection in setting of immunosuppression
Pregnancy and lactation
Pregnancy category: d
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Leustatin (cladribine)
Mechanism of action
Purine analog, impairs DNA repair
Pharmacokinetics
Half-Life: 5.4 hr
Protein bound: 20%
Vd: 4.5 L/kg
Clearance: 978 mL/hr/kg
Excretion: urine
Administration
IV Incompatibilities
Solution: D5W
Y-site: none reported
IV Compatibilities
Y-site (partial list): carboplatin, cisplatin, cyclophosphamide, cytarabine, diphenhydramine, dopamine, etoposide, heparin, lorazepam, metoclopramide, morphine, ondansetron, paclitaxel, KCl, prochlorperazine, promethazine, NaHCO3, teniposide, vincristine
IV Preparation
Single-use vials
Prepare with bacteriostatic Ns
Both cladribine and diluent should be passed through a sterile 0.22 micron hydrophilic filter as they are being introduced into infusion reservoir
The calculated dose of cladribine (7 days x 0.09 mg/kg) should first be added to the infusion reservoir through a filter, then the bacteriostatic NS should be added to the reservoir to obtain a total volume of 100 mL
Standard IV 24 hr infusion dilution: 24 hr dose/500 mL Ns
Standard IV 7 day infusion dilution: 7 day dose/QS to 100 mL with bacteriostatic Ns
Do not dilute in D5W
IV Administration
Single daily infusion: administer diluted in an infusion bag containing 500 mL of NS and repeated for a total of 7 consecutive days
7 day infusion: administer via ambulatory infusion pump into central line; use 0.22 micron filter to infuse
Storage
Store intact vials under refrigeration
