Is isotretinoin REMS requirement include which of the following?

• A. Pregnancy test, 30 day supply max, >12 years old
• B. No pregnancy test required
• C. 60 day supply max
• D. Only males

Answer: (A)

Isotretinoin REMS is built around preventing fetal exposure because the drug is highly teratogenic. To achieve that, the program requires a pregnancy test for females of reproductive potential before starting isotretinoin and at designated intervals during treatment, and it restricts dispensing to short 30‑day supplies with ongoing monitoring. It also sets an age minimum so that eligible patients are typically over 12 years old. Taken together, the option that includes a pregnancy test, a 30‑day supply limit, and being over 12 years old reflects how the REMS program manages safety. The other statements clash with these safeguards: skipping pregnancy testing, allowing a longer supply, or specifying only males would miss key precautions designed to prevent pregnancy during therapy.