Inform patients that MAVENCLAD may increase their risk of malignancies. Instruct patients tofollow standard cancer screening guidelines [see Dosage and Administration (2) and Warningsand Precautions (5.1)].
Risk of Teratogenicity
Inform patients that MAVENCLAD may cause fetal harm. Discuss with women of childbearingage whether they are pregnant, might be pregnant, or are trying to become pregnant. Beforeinitiating each treatment course, inform patients about the potential risk to the fetus, if femalepatients or partners of male patients get pregnant during MAVENCLAD dosing or within6 months after the last dose in each treatment course [see Warnings and Precautions (5.2) andUse in Specific Populations (8.1, 8.3)].
https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/mavenclad-pi.pdf |
