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Juxtapid
lomitapide
Black Box Warnings .
Appropriate Use
restricted distribution program (JUXTAPID REMS) due to hepatotoxicity risk; prescribers, pharmacies must be certified and enroll at 1-855-898-2743 or www.juxtapidremsprogram.com; prescribe only to patients w/ clinical or laboratory diagnosis consistent w/ homozygous familial hypercholesterolemia; safety and efficacy not estab. in other hypercholesterolemia patients
Hepatotoxicity Risk
ALT/AST incr. >3x ULN in 34% of patients in clinical trial; no clinically meaningful incr. in total bilirubin, INR, alk phos observed; median hepatic fat incr. from 1% to 6% after 26wk and 78wk of tx; lomitapide-assoc. hepatic steatosis may be risk factor for progressive hepatic dz, incl. steatohepatitis and cirrhosis; monitor LFTs at baseline, then at least ALT/AST regularly as recommended; adjust dose if ALT/AST >3x ULN; D/C tx for clinically significant hepatotoxicity
Adult Dosing .
Dosage forms: CAP: 5 mg, 10 mg, 20 mg, 30 mg
Restricted Distribution in US
- [1-855-898-2743 or www.juxtapidremsprogram.com for more info]
homozygous familial hypercholesterolemia
- [5-60 mg PO qd]
- Start: 5 mg PO qd x2wk, then may double dose q4wk; Max: 60 mg/day; Info: see pkg insert for dose adjustments based on ALT/AST; give >2h after evening meal; do not open cap; fat-soluble vitamin supplementation recommended
renal dosing
- [see below]
- renal impairment: not defined
- HD: max 40 mg/day; supplement after dialysis not defined; PD: max 40 mg/day; supplement not defined
hepatic dosing
- [see below]
- Child-Pugh Class A: max 40 mg/day; Child-Pugh Class B or C: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.