Chapters Transcript Video Mechanism of Action NEXLETOL NEXLIZET be empathetic acid is the active ingredient in Next little developed by esperion therapeutics. Bemba domoic acid is delivered as a once daily tablet with an innovative mechanism complementary to yet distinct from other lipid lowering therapies within the happen to cite endogenous cholesterol is synthesized along the cholesterol bio synthesis pathway through a series of enzymatic interactions which includes h M G koa reductase, the primary target of statins. Mhm. Being pedantic acid has a mechanism that is complementary to status when activated in the liver. Bemba domoic acid inhibits a denizen triphosphate citrate lioce known as act an enzyme two steps upstream from h M G koa reductase. By inhibiting A. C. L. Bmp joke acid reduces cholesterol synthesis, resulting in LDL receptor up regulation and increased clearance of LDL cholesterol from the bloodstream. Of note. Ben Padoa Cassidy is a pro drug converted primarily in the liver to its active minority by a C. S. V. L one ACSVL one is not present in skeletal muscle. Therefore, Bemba domoic acid is not converted to its active minority within skeletal muscle. Yeah, Bemba domoic acid is also available as an active ingredient in Next Lizette, a combination tablet with his Namib developed by a Syrian therapeutics that has complementary mechanisms of action. Been potomac acid inhibits cholesterol synthesis via a cl inhibition primarily in the liver, While his enemies blocks gastrointestinal cholesterol absorption via MPC one L 1 inhibition, reducing cholesterol delivery to the liver. These complementary mechanisms result in LDL receptor up regulation and increased LDL C clearance from the bloodstream indication. Next little and next Lizette are indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with hetero zegas, familial hypercholesterolemia or established atherosclerotic cardiovascular disease. Who require additional lowering of LDL C limitations of use the effect of Next little and next Lizette on cardiovascular morbidity and mortality has not been determined important. Safety information, dosage form and quantity. Next little is available as an oral tablet containing 180 mg of epidemic acid taken once a day with or without food. Next Lizette is available as an oral tablet containing 180 mg of Mehmedovic acid and 10 mg of is it might be taken once a day with or without food contra indications. Next little has no contraindications. Next Lizette is contra indicated in patients with a known hypersensitivity to Rosetta. My tablets, hypersensitivity reactions including anaphylaxis, angio oedema, rash and arctic area have been reported with his ETA. My babe warnings and precautions. Hyper euros. Anemia. Mehmedovic acid, a component of Next little and next Lizette may increase blood uric acid levels, Hyper euros. Anemia may occur early in treatment and persist throughout treatment and may lead to the development of gout, especially in patients with a history of gout tendon rupture. Mehmedovic acid is associated with an increased risk of tendon rupture. Most commonly involving the biceps tendon, rotator, cuff or achilles tendon tendon rupture occurred within weeks to months of starting Bemba domoic acid, Tendon rupture may occur more frequently in patients over 60 years of age, patients taking corticosteroid or flora. Queen alone drugs, patients with renal failure and patients with previous Tendon disorders, adverse events in next little clinical trials. The most commonly reported adverse events were upper respiratory tract infection, muscle spasms, hyper euros, anemia, back pain, abdominal pain or discomfort bronchitis, pain in extremity, anaemia and elevated liver enzymes. Events reported less frequently but still more often than in placebo included benign prostatic hyperplasia and atrial fibrillation. In the next Lizette clinical trial, the most commonly reported adverse events observed with Next Lizette but not observed in clinical trials have been paid OIC acid or is it a MIB a component of Next Lizette and occurring more frequently than in placebo? Were urinary tract infection, Nasopharynx itis and constipation adverse events reported in clinical trials of his ultimate and occurring at an incidents greater than in placebo included upper respiratory tract infection, diarrhea, arthur, alga sinusitis, pain in extremity, fatigue and influenza. Other adverse events reported in post marketing use of his infamy be included hypersensitivity reactions including anaphylaxis, angio oedema rash and urged Ikaria erythema. Multiforme, a nostalgia, elevated creatine phosphate, penis, myopathy, rhabdomyolysis, elevations in liver trans AM in ISIS. Hepatitis abdominal pain, thrombosis, leukemia, pancreatitis, nausea, dizziness, paris, the asia depression, headache called elephantiasis, cola cystitis. Laboratory tests treatment with Mehmedovic acid was associated with persistent changes in laboratory tests within the first four weeks of treatment, including increases in creatinine and blood urea nitrogen decreases in haemoglobin and Lucas sites, increases in platelet counts, increases in liver enzymes, S. T. And are built and increases in creating kindness. Laboratory abnormalities generally did not require medical intervention. Laboratory test values generally returned to baseline following discontinuation of treatment. Drug interactions, simvastatin and pravastatin. Concomitant use with Mehmedovic acid results in increased concentrations and increased risk of simvastatin or pravastatin related myopathy. Use of either next little or next Lizette with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided cyclists. Warren caution should be exercised when using next lisette and cyclosporin concomitantly due to increased exposure to both gazeta. MIB and cyclosporin. Monitor cyclosporin concentrations in patients receiving next Lizette and cyclosporin. In patients treated with cyclosporin. The potential effects of the increased exposure to a set amid from concomitant use should be carefully weighed against the benefits of alterations in lipid levels provided by next Lizette vibrates. Co administration of next Lizette with vibrates other than Fenno vibrate is not recommended Fenno vibrate and is it um it may increase cholesterol excretion into the bile leading to call a with ISIS. If cola with ISIS is suspected in a patient receiving next Lizette and fennel vibrate, gallbladder. Studies are indicated and alternative lipid lowering therapy should be considered coalesced. I remain concomitant use of next Lizette and Kostyra mean decreases is set amid concentration. This may result in a reduction of efficacy, administer next Lizette either at least two hours before or at least four hours after bile acids, equestrians, special populations, it is not recommended that next little or next Lizette be taken during breastfeeding. A pregnant patient should consult with their health care provider about whether to continue treatment during the pregnancy. The safety and efficacy of next little and next Lizette have not been established in patients under the age of 18, Patients over 65 accounted for nearly 60% of patients in next little clinical trials and 50% of patients in the next Lizette clinical trial, no adjustments inducing are required for age or for patients with mild or moderate renal impairment or mild hepatic impairment for next little or next Lizette. No adjustments endorsing are required for patients with moderate hepatic impairment for next little Next Lizette is not recommended for patients with moderate or severe hepatic impairment. Next, the tall and next Lizette are available only by prescription to report suspected adverse reactions. Contact FDA at 1 800 FDA 1088 or www dot f d. A dot gov forward slash med watch or experience at 8333777633833 E s p e r m e D. Please see full prescribing information for next little and next Lizette at next Little HCP dot com or next Lizette. HCP dot com Experience is singularly focused on innovative research to help patients achieve their LDL C goals. Published June 7, 2021 Created by
