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U.S. Department of Health and Human Services


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Leustatin (Cladribine) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View



  • Due to increased risk of infection in the setting of immunosuppression with chemotherapy including Leustatin, it is recommended not to administer live attenuated vaccines to patients receiving Leustatin Injection….
Pregnancy Category D
  • Leustatin can cause fetal harm when administered to a pregnant woman. Although there is no evidence of teratogenicity in humans due to Leustatin, other drugs which inhibit DNA synthesis have been reported to be teratogenic in humans. Cladribine is teratogenic in animals…


Impairment of Fertility
  • The effect on human fertility is unknown. When administered intravenously to Cynomolgus monkeys, cladribine has been shown to cause suppression of rapidly generating cells, including testicular cells…


Clinical Trials Experience
  • Adverse drug reactions reported by ≥ 1% of Leustatin-treated patients with HCL noted in the HCL clinical dataset (studies K90-091 and L91-048, n=576) are shown in the table below…
  • The vast majority of rashes were mild. Most episodes of nausea were mild, not accompanied by vomiting, and did not require treatment with antiemetics…
  • When used in other clinical settings the following ADRs were reported: bacteremia, cellulitis, localized infection, pneumonia, anemia, thrombocytopenia (with bleeding or petechiae), phlebitis, purpura, crepitations, localized edema and edema…
Postmarketing Experience
  • The following additional adverse reactions have been reported since the drug became commercially available…