NEXLIZET

Absorption NEXLIZET The bioavailability of NEXLIZET tablets was similar relative to that from the individual tablets, coadministered. Maximum plasma concentration (C max ) values for bempedoic acid and its active metabolite (ESP15228) were similar between formulations, but ezetimibe glucuronide and ezetimibe C max values were approximately 22% and 13% lower, respectively, for NEXLIZET relative to the individual tablets, coadministered. Given a similar overall extent of ezetimibe glucuronide and ...

14.1 Primary Hypercholesterolemia Trials in Adults The efficacy of NEXLIZET was investigated in a single, multi-center, randomized, double-blind, placebo-controlled, parallel group trial that enrolled 301 patients with HeFH, established CVD, or multiple risk factors for CVD on maximally tolerated statin therapy.

Trial 1(NCT03337308) was a 4-arm, 12-week trial that assessed the efficacy of NEXLIZET in 301 patients randomized 2:2:2:1 to receive either oral NEXLIZET (180 mg of bempedoic acid and 10 mg of ezetimibe) (n = 86), bempedoic acid 180 mg (n = 88), ezetimibe 10 mg (n = 86), or placebo (n...

The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperuricemia [see Warnings and Precautions (5.1) ] Tendon Rupture [see Warnings and Precautions (5.2) ] Common adverse reactions with NEXLIZET in the primary hypercholesterolemia trials (incidence ≥ 2% and more frequently than placebo) were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver en...

NEXLIZET is contraindicated in patients with a prior hypersensitivity to ezetimibe or bempedoic acid or any of the excipients in NEXLIZET [see Adverse Reactions (6.2) ] . Serious hypersensitivity reactions, such as anaphylaxis, angioedema, rash and urticaria have been reported with ezetimibe or bempedoic acid. Known hypersensitivity to ezetimibe or bempedoic acid or any of the excipients in NEXLIZ...

Hyperuricemia: Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. ( 5.1 ) Tendon Rupture: Tendon rupture has occurred. Discontinue NEXLIZET at the first sign of tendon rupture. Avoid NEXLIZET in patients who have a history of tendon disorders or tendon rupture. ( 5.2 ) 5.1 Hyperuricemia Bempedoic acid, a component of NEXLIZET, i...

7 DRUG INTERACTIONS No specific pharmacokinetic drug interaction studies with NEXLIZET have been conducted. Table 4 lists drug interactions with NEXLIZET that have been identified in studies with bempedoic acid or ezetimibe. Table 4. Clinically Important Drug Interactions with NEXLIZET Simvastatin Clinical Impact: Concomitant use of NEXLIZET with simvastatin causes an increase in simvastatin conce...