Hypersensitivity to the active substance(s) or to any of the excipients.
Pregnancy and lactation (see Use in Pregnancy & Lactation).
Active liver disease or unexplained persistent elevations in serum transaminases.
Simvastatin is contraindicated with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and drugs containing cobicistat), gemfibrozil, ciclosporin and danazol (see Precautions and Interactions).
In patients with HoFH, concomitant administration of lomitapide with doses > 10/40 mg VYTORIN (see Dosage & Administration, Precautions and Interactions).