Cladribine – intravenous

Additional information

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 [1].

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 [2]. In a US study, African Americans were found to have a poorer overall survival compared to other ethnic groups [2].

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].

Effects

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 [6].

Adverse effects

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 [7].

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 [5]. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).