Therapeutic Indications

Cladribine is indicated for:

Hairy cell leukemia

Irrespective of gender only Adults (18 years old or older)

Cladribine is indicated for the treatment of hairy cell leukaemia.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Subcutaneous - 0.14 mg/kg body weight once a day for 5 days

Treatment 2: Intravenous - 0.09 mg/kg/day continuous intravenous infusion for 7 consecutive days

Relapsing multiple sclerosis (MS)

Irrespective of gender only Adults (18 years old or older)

Cladribine is indicated for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 10-20 mg once daily for 5 days every month

Contraindications

Active ingredient Cladribine is contraindicated in the following cases:

Moderate to severe renal impairment (creatinine clearance ≤50 ml/min)

No gender/age discrimination

Moderate to severe hepatic impairment (Child-Pugh score ≥6)

No gender/age discrimination

Myelosuppressive medicinal products

No gender/age discrimination

Concomitant use of other myelosuppressive medicinal products.

Due to a potential increase of haematological toxicity and bone marrow suppression, cladribine must not be used concomitantly with other myelosuppressive medicinal products. An influence of cladribine on the activity of other antineoplastic agents has not been observed in vitro (e.g. doxorubicin, vincristine, cytarabine, cyclophosphamide) and in vivo. However, an in vitro study revealed cross-resistance between cladribine and nitrogen mustard (chlormethine); for cytarabine, one author has described an in vivo cross-reaction without loss of activity.

Lactation

No gender/age discrimination

It is not known whether cladribine is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding is contraindicated during treatment with cladribine and for 1 week after the last oral dose and 6 months after the last intravenous dose.

Pregnancy

No gender/age discrimination

Based on human experience with other substances inhibiting DNA synthesis, cladribine could cause congenital malformations when administered during pregnancy. Studies in animals have shown reproductive toxicity.

Cladribine injection should not be given during pregnancy. Women of childbearing potential must use effective contraception during treatment with cladribine and for 6 months after the last cladribine dose. If cladribine injection is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.

Cladribine is teratogenic in mice and rabbits. A significant increase in foetal variations was observed in mice receiving 1.5 mg/kg/day (4.5 mg/m², a dose approximately equivalent to the recommended dose in humans of 3.6 mg/m²). Increased resorptions, reduced litter size, and increased foetal malformations were observed when mice received 3.0 mg/kg/day (9 mg/m²). Foetal death and malformations were observed in rabbits that received 3.0 mg/kg/day (33.0 mg/m²). No adverse foetal effects were seen in mice at 0.5 mg/kg/day (1.5 mg/m²) or in rabbits at 1.0 mg/kg/day (11.0 mg/m²).

Cladribine is contraindicated in pregnant women.