DL-C for LIPTRUZET vs. the coadministered components, respectively, were -54.0% vs. -53.8% for 10/20-mg (Study 1), and -58.9% vs. -58.7% for 10/40-mg (Study 2). Mean changes for total-C, Apo B, TG, non-HDL-C, and HDL-C were also similar between the two treatment groups and supported the conclusion of clinical equivalence.
14.2 Homozygous Familial Hypercholesterolemia (HoFH)A double-blind, randomized, 12-week study was performed in patients with a clinical and/or genotypic diagnosis of HoFH. Data were analyzed from a subgroup of patients (n=36) receiving atorvastatin 40 mg at baseline. Increasing the dose of atorvastatin from 40 to 80 mg (n=12) produced a reduction of LDL-C of 2% from baseline on atorvastatin 40 mg. Coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET (10/40 and 10/80 pooled, n=24), produced a reduction of LDL-C of 19% from baseline on atorvastatin 40 mg. In those patients coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET (10/80, n=12), a reduction of LDL-C of 25% from baseline on atorvastatin 40 mg was produced.
After completing the 12-week study, eligible patients (n=35), who were receiving atorvastatin 40 mg at baseline, were assigned to coadministered ezetimibe and atorvastatin equivalent to LIPTRUZET 10/40 for up to an additional 24 months. Following at least 4 weeks of treatment, the atorvastatin dose could be doubled to a maximum dose of 80 mg.
At the end of the 24 months, LIPTRUZET (10/40 and 10/80 pooled) produced a reduction of LDL-C that was consistent with that seen in the 12-week study.
16 HOW SUPPLIED/STORAGE AND HANDLING
Tablets LIPTRUZET 10 mg/10 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code "320" on one side.
They are supplied as follows:
NDC 66582-320-30 unit of use packages of 30 (three foil pouches each containing one 10-count blister card)
NDC 66582-320-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)
Tablets LIPTRUZET 10 mg/20 mg are white to off-white round, biconvex film-coated tablets with code "321" on one side.
They are supplied as follows:
NDC 66582-321-30 unit of use packages of 30 (three foil pouches each containing one 10-count blister card)
NDC 66582-321-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)
Tablets LIPTRUZET 10 mg/40 mg are white to off-white oval, biconvex film-coated tablets with code "322" on one side.
They are supplied as follows:
NDC 66582-322-30 unit of use packages of 30 (three foil pouches each containing one 10-count blister card)
NDC 66582-322-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)
Tablets LIPTRUZET 10 mg/80 mg are white to off-white capsule-shaped, biconvex film-coated tablets with code "323" on one side.
They are supplied as follows:
NDC 66582-323-30 unit of use packages of 30 (three foil pouches each containing one 10-count blister card)
NDC 66582-323-54 unit of use packages of 90 (nine foil pouches each containing one 10-count blister card)
Storage of Unit of Use Packages of 30 and 90
Store LIPTRUZET at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in the foil pouch until use. After the foil pouch is opened, protect LIPTRUZET from moisture and light. Once a tablet is removed, slide blister card back into case. Store the case in a dry place, and dis |
