Adult Dosing
Homozygous familial hypercholesterolemia
- Start treatment at 5 mg PO qday; may gradually increase dose based on tolerability and response; increase to 10 mg daily after at least 2 weeks; and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and up to the maximum recommended dose of 60 mg daily
- Max: 60 mg/day
- Patients with end-stage renal disease on dialysis or with baseline mild hepatic impairment should not exceed 40 mg daily
Note:
- Before initiating treatment, measure ALT, AST, alkaline phosphatase, and total bilirubin; obtain a negative pregnancy test in females of reproductive potential; and initiate a low-fat diet supplying <20% of energy from fat
- Because of the action of lomitapide in the small intestine, administer with daily supplements that contain vitamin E 400 IU, linoleic acid 200 mg, alpha-linolenic acid 210 mg, eicosapentaenoic acid 110 mg, and docosahexaenoic acid 80 mg to reduce the risk of developing a fat-soluble nutrient deficiency
- Take once daily, whole, with water and without food, at least 2 hours after evening meal
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment: (Based on CrCl)
- Mild, moderate or severe impairment: dose adjustments not defined
- Patients with ESRD not yet receiving dialysis: dose adjustments not defined
- Patients with ESRD receiving dialysis: Max dose: 40 mg/day
Hepatic Dose Adjustment:
- Child Pugh A: Max: 40 mg/day
- Child-Pugh B or C: Contraindicated
Administration with CYP3A4 inhibitors:
- Strong and moderate CYP3A4 inhibitors are contraindicated
- Do not exceed 30 mg/day when used concomitantly with weak CYP3A4 inhibitors
Pregnancy Category:X
Breastfeeding: It is unknown whether lomitapide is distributed in breast milk; because of the potential for tumorigenicity, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother