Nexlizet

Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, as adjunct to diet in combination w/ statin in patients unable to reach LDL-C goals w/ max tolerated dose of statin in addition to ezetimibe; alone in patients who are either statin-intolerant or for whom statin is contraindicated, & are unable to reach LDL-C goals w/ ezetimibe alone; or in patients already being treated w/ combination of bempedoic acid & ezetimibe as separate tab w/ or w/o statin. Adults w/ established or at high risk for ASCVD to reduce CV risk by lowering LDL-C levels, as adjunct to correction of other risk factors in patients on max tolerated dose of statin & not adequately controlled w/ additional ezetimibe treatment; in patients who are either statin-intolerant, or for whom statin is contraindicated, & not adequately controlled w/ ezetimibe treatment; or in patients already being treated w/ combination of bempedoic acid & ezetimibe as separate tab.

1 FC tab once daily. Coadministration w/ bile acid sequestrants Take at least 2 hr before or 4 hr after administration of bile acid sequestrant. Concomitant simvastatin therapy Limit simvastatin dose to 20 mg daily (or 40 mg daily for patients w/ severe hypercholesterolaemia & high risk for CV complications, who have not achieved their treatment goals on lower doses & when benefits are expected to outweigh potential risks).

May be taken with or without food: Swallow whole.

Hypersensitivity. Active liver disease or unexplained persistent serum transaminases elevations in coadministration w/ statin. Concomitant use w/ simvastatin >40 mg daily. Pregnancy & lactation.

Immediately discontinue treatment & any statin if myopathy is confirmed by creatine phosphokinase level >10x ULN. Discontinue treatment if hyperuricaemia accompanied w/ gout symptoms appear; increase in transaminases of >3x ULN persists; if cholelithiasis is suspected in concomitant use w/ fenofibrate. Potential increased risk of myopathy in addition to statin. Consider lower max dose of statin or treatment discontinuation & initiation of alternative lipid-lowering therapy if unexplained muscle pain, tenderness or weakness occur. Use in patients at high risk of CV disease is for lipid-lowering effect in absence of any CV risk reduction estimation for ezetimibe in primary prevention patients. May raise serum uric acid level; cause or exacerbate hyperuricaemia & precipitate gout in patients w/ medical history of or predisposed to gout. Monitor ciclosporin conc when used concomitantly; INR if added to warfarin, other coumarin anticoagulants or fluindione. Additional monitoring of adverse reactions in patients receiving treatment as adjunct to statin; w/ severe renal impairment (estimated GFR <30 mL/min/1.73 m²) & ESRD on dialysis. Perform LFTs at initiation of therapy; gallbladder investigations if cholelithiasis is suspected. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Not recommended in patients w/ moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Women of childbearing potential must use effective contraception during treatment. Discontinue treatment prior to conception or as soon as pregnancy is recognized. Childn <18 yr.

Anaemia, decreased Hb; hyperuricaemia, decreased appetite; dizziness, headache; HTN; cough; constipation, diarrhoea, abdominal pain, nausea, dry mouth, flatulence, gastritis; increased LFT; back pain, muscle spasms, myalgia, pain in extremity, arthralgia; increased blood creatinine; fatigue, asthenia. Bempedoic acid: Gout; increased AST; decreased GFR. Ezetimibe: Increased blood creatine phosphokinase.

Ezetimibe: Modestly increased total conc w/ fenofibrate or gemfibrozil. Concomitant use w/ ciclosporin increases ezetimibe & ciclosporin AUC. Decreased mean AUC w/ cholestyramine. Increased INR w/ warfarin or fluindione. Bempedoic acid: Increased simvastatin acid exposure. AUC elevations of atorvastatin, pravastatin & rosuvastatin (as single doses) &/or their major metabolites. Increased plasma conc of OATP1B1 or OATP1B3 (ie, bosentan, fimasartan, asunaprevir, glecaprevir, grazoprevir, voxilaprevir, atorvastatin, pravastatin, fluvastatin, pitavastatin, rosuvastatin, simvastatin); OAT2 substrates. May weakly inhibit OAT3 at clinically relevant conc.

Dyslipidaemic Agents

C10BA10 - bempedoic acid and ezetimibe ; Belongs to the class of HMG CoA reductase inhibitors in combination with other lipid modifying agents. Used in the treatment of hyperlipidemia.

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