Nexletol

Adults w/ primary hypercholesterolaemia (heterozygous familial & non-familial) or mixed dyslipidaemia, as adjunct to diet in combination w/ statin or statin w/ other lipid-lowering therapies in patients unable to reach LDL-C goals w/ max tolerated dose of statin, or alone or in combination w/ other lipid-lowering therapies in patients who are statin-intolerant, or for whom statin is contraindicated. 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 w/ or w/o ezetimibe, or alone or in combination w/ ezetimibe in patients who are statin-intolerant, or for whom statin is contraindicated.

1 FC tab once daily. 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. 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. 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. May raise serum uric acid level; cause or exacerbate hyperuricaemia & precipitate gout in patients w/ medical history of or predisposed to gout. Perform LFTs at initiation of therapy; in patients w/ severe hepatic impairment. 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. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. 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; gout, hyperuricaemia; increased AST; pain in extremity; decreased GFR.

Increased simvastatin acid exposure. AUC elevations of atorvastatin, pravastatin, & rosuvastatin (as single doses) &/or their major metabolites. Increased plasma conc of OATP1B1 or OATP1B3 substrates (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

C10AX15 - bempedoic acid ; Belongs to the class of other lipid modifying agents.

S