Cladribine – intravenousClassification: A
Drug products: Leustatin, Litak
ATC code: L01BB04
One small study in patients with Hairy Cell Leukemia showed similar effects regarding overall survival and progression-free survival in men and women. Another study found women, as well as persons with thrombocytopenia or prior radiotherapy, to be at higher risk of developing cytopenia and thus not being able to complete the treatment.
Cladribine i.v. has been used in treatment of Hairy Cell Leukemia (HCL) since the 1990s and was designated an orphan medicine 2001-2014 in the EU .
HCL is an uncommon form of leukemia that is almost three times as common in men than women [2-3]. With treatment, the overall survival is often very good in both men and women . In a US study, African Americans were found to have a poorer overall survival compared to other ethnic groups .
Pharmacokinetics and dosing
No studies with a clinically relevant sex analysis regarding pharmacokinetics of cladribine i.v. have been found in the literature searches. The manufacturer recommends the same mg/kg dose in men and women [4-5].
In a study of patients with HCL treated with different administration patterns of cladribine (50 men, 11 women) there was no difference between men and women in overall survival or progression-free survival .
A small study of i.v. cladribine treated patients (24 men, 14 women) with HCL found thrombocytopenia, prior radiotherapy, and female sex to be factors predicting the risk of cytopenia and thus termination of cladribine treatment .
Reproductive health issues
Highly effective contraception is recommended when using cladribine [4-5]. It is recommended that men treated with i.v. cladribine should be advised not to father a child up to 6 months after treatment and to seek advice of cryoconservation of sperm prior to treatment as there is a possibility of infertility due cladribine treatment . Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2018-01-10
- Litak (cladribine). EPAR - Scientific Discussion. European Medicines Agency (EMA); 2005.
- Giri S, Shrestha R, Pathak R, Bhatt VR. Racial Differences in the Overall Survival of Hairy Cell Leukemia in the United States: A Population-Based Analysis of the Surveillance, Epidemiology, and End Results Database. Clin Lymphoma Myeloma Leuk. 2015;15:484-8. PubMed
- Teodorescu M, Engebjerg MC, Johansen P, Nørgaard M, Gregersen H. Incidence, risk of infection and survival of hairy cell leukaemia in Denmark. Dan Med Bull. 2010;57:A4216. PubMed
- Litak (cladribine) Drug Label. DailyMed [www]. US National Library of Medicine. [updated 2016-11-01, cited 2018-01-10]. länk
- Litak (cladribine). Summary of Product Characteristics. European Medicines Agency (EMA); 2009.
- Madanat YF, Rybicki L, Radivoyevitch T, Jagadeesh D, Dean R, Pohlman B et al. Long-Term Outcomes of Hairy Cell Leukemia Treated With Purine Analogs: A Comparison With the General Population. Clin Lymphoma Myeloma Leuk. 2017;17:857-862. PubMed
- Van Den Neste E, Michaux L, Layios N, Costantini S, Francart J, Lambert C et al. High incidence of complications after 2-chloro-2'-deoxyadenosine combined with cyclophosphamide in patients with advanced lymphoproliferative malignancies. Ann Hematol. 2004;83:356-63. PubMed
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2018-02-02.] länk
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson