se to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.
1.1 Primary HyperlipidemiaLIPTRUZET™ is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
1.2 Homozygous Familial Hypercholesterolemia (HoFH)LIPTRUZET is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
1.3 Limitations of UseNo incremental benefit of LIPTRUZET on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established. LIPTRUZET has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended DosingThe dosage range of LIPTRUZET is 10/10 mg/day to 10/80 mg/day. The recommended starting dose of LIPTRUZET is 10/10 mg/day or 10/20 mg/day. LIPTRUZET can be administered as a single dose at any time of the day, with or without food. The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 10/40 mg/day. After initiation and/or upon titration of LIPTRUZET, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.
Patients should swallow LIPTRUZET tablets whole. Tablets should not be crushed, dissolved, or chewed.
2.2 Patients with Homozygous Familial HypercholesterolemiaThe dosage of LIPTRUZET in patients with homozygous familial hypercholesterolemia is 10/40 mg/day or 10/80 mg/day. LIPTRUZET should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.
2.3 Coadministration with Other Drugs
Bile Acid Sequestrants
Dosing of LIPTRUZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.11)].
Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors
In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with LIPTRUZET should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing LIPTRUZET and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with LIPTRUZET should be limited to 10/20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPTRUZET is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with LIPTRUZET should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPTRUZET is employed. [See Warnings and Precautions (5.1) and Drug Interactions (7).]
Other Concomitant Lipid-Lowering Therapy
The c |
