Nustendi

Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination w/ statin in patients unable to reach LDL-C goals w/ max tolerated statin dose in addition to ezetimibe; alone in patients who are either statin-intolerant or for whom a statin is contraindicated, & are unable to reach LDL-C goals w/ ezetimibe alone; 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 an adjunct to correction of other risk factors: in patients on max tolerated statin dose & not adequately controlled w/ additional ezetimibe treatment; or in patients who are either statin-intolerant or for whom a 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 tab once daily. If co-administered w/ a bile acid sequestrant, administer at least 2 hr before or at least 4 hr after bile acid sequestrant. If co-administered w/ simvastatin, 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. Concomitant use w/ simvastatin >40 mg daily. Co-administration w/ statin in patients w/ active liver disease or unexplained persistent elevations in serum transaminases. Pregnancy & lactation.

Potential increased risk of myopathy w/ concomitant use of statins. Promptly report any unexplained muscle pain, tenderness, or weakness. Immediately discontinue Nustendi & any concomitantly used statin if myopathy is confirmed by creatine phosphokinase (CPK) level >10x ULN. May raise serum uric acid level & may cause or exacerbate hyperuricaemia & precipitate gout in patients w/ medical history of gout or predisposed to gout. Discontinue treatment if hyperuricaemia accompanied w/ symptoms of gout appear. Risk of elevated liver enzymes. Perform LFTs at initiation of therapy. Discontinue treatment if increase in transaminases of >3x ULN persists. Safety & efficacy of ezetimibe administered w/ fibrates have not been established. Discontinue co-administration of Nustendi & fenofibrate if cholelithiasis is suspected. Monitor ciclosporin conc if Nustendi is co-administered w/ ciclosporin. Appropriately monitor INR if Nustendi is added to warfarin, other coumarin anticoagulants, or fluindione. Evidence for the use of the fixed combination in patients at high risk of CV disease is only available for the lipid-lowering effect in absence of any CV risk reduction estimation for ezetimibe in primary prevention patients. Should not 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. Additional monitoring for adverse reactions when administered in patients w/ severe renal impairment (eGFR <30 mL/min/1.73 m²) & patients w/ ESRD on dialysis. Not recommended in patients w/ moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Women of childbearing potential should use effective contraception during treatment. Safety & efficacy in childn <18 yr have not yet been established.

Nustendi: 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 CPK.

Bempedoic acid: Increased AUC of bempedoic acid & its active metabolite (ESP15228) w/ probenecid. Increased exposure of simvastatin acid. Elevated AUC of atorvastatin, pravastatin, rosuvastatin, &/or their major metabolites. Increased plasma conc of OATP1B1 or OATP1B3 substrates (ie, bosentan, fimasartan, asunaprevir, glecaprevir, grazoprevir, voxilaprevir, & statins eg, atorvastatin, pravastatin, fluvastatin, pitavastatin, rosuvastatin, simvastatin). Potentially increased plasma conc of OAT2 substrates. Ezetimibe: Modestly increased conc of total ezetimibe w/ fenofibrate or gemfibrozil. Increased AUC of total ezetimibe w/ ciclosporin. Increased AUC of ciclosporin. Decreased AUC of total ezetimibe w/ cholestyramine. Risk of increased INR w/ warfarin or fluindione.

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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