In the US it is only available for doctors who follow an FDA-mandated risk evaluation and mitigation strategy, that involves documenting a negative pregnancy test before prescribing the drug, counseling about contraception, and regular pregnancy tests.
In the US it is only available for doctors who follow an FDA-mandated risk evaluation and mitigation strategy (REMS) with respect to risks to fetuses and its risks of causing liver damage. The doctor must document a negative pregnancy test for women before prescribing the drug, counsel about contraception, and give regular pregnancy tests.