Box 2.

Specific requirements from the European labelling relating to avoidance of pregnancy and breastfeeding during and after treatment with cladribine tablets 3.5 mg/kg

Contraception

Counsel women of childbearing potential and men who could potentially father a child on the need for effective contraception during, and for at least 6 months after, administration of cladribine tablets 3.5 mg/kg

Women using systemic hormonal contraception should add a barrier method during, and for 4 weeks after, administration of cladribine tablets 3.5 mg/kg

Pregnancya

Pregnancy must be excluded before initiation of treatment with cladribine tablets 3.5 mg/kg

Stop treatment immediately if pregnancy occurs during administration of cladribine tablets 3.5 mg/kg

Breastfeedinga

Women should not breastfeed during treatment with, and for 1 week after, administration of cladribine tablets 3.5 mg/kg

Compiled from Mavenclad® 10 mg tablets European Summary of Product Characteristics [5]. Information is paraphrased for brevity: local full labelling should be checked before prescribing

aRequirements for avoidance of pregnancy and breastfeeding apply to both treatment years 1 and 2