A 28-year-old woman starting mycophenolate after kidney transplant. Which counseling point most reflects the FDA REMS program?

Correct (2): <span class="merci-kw-mark">Mycophenolate is highly teratogenic</span> — REMS program requires <span class="merci-kw-mark">two forms of contraception</span> during treatment and for 6 weeks after last dose. Pregnancy test before initiation. Counseling and enrollment mandated. Also expect GI (diarrhea, nausea) and leukopenia. (1,3,4) Wrong.

In-depth explanation

<span class="merci-scenario-label">Memory Tip</span> Mycophenolate (MMF/MPA) = "Mom NO" — REMS for teratogenicity. Use 2 contraceptives + pregnancy testing. Common GI side effects: convert to enteric-coated mycophenolate sodium.

Clinical scenario

<span class="merci-scenario-label">Scenario</span> 28-year-old female starting <span class="merci-kw-mark">mycophenolate</span> post-kidney transplant. Sexually active, not currently pregnant.

Key concepts

• Mycophenolate — Anti-proliferative immunosuppressant; teratogenic; GI side effects.
• Mycophenolate REMS — Mandatory program; 2 contraceptive methods, pregnancy testing, education.
• GI dose-limiting effect — Diarrhea is the most common reason for dose reduction or switch.