If a new-to-market drug falls into an existing class/category, the drug will be considered non-preferred and subject to this class/category prior authorization (PA) criteria Background: Lomitapide is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other Lomitapide is a microsomal triglyceride transfer protein inhibitor used to lower cholesterol associated with homozygous familial hypercholesterolemia (HoFH), reducing risk of cardiovascular events such as myocardial infarction and stroke. Ezetimibe • M oderate or severe hepatic impairme nt [Child -Pugh classes B and C] . Such synthetic mRNA can be engineered to transiently express proteins by structurally resembling natural mRNA. Lomitapide has been approved by the US Food and Drug Adminis … 2014. Statins also are effective in reducing triglyceride levels in patients with . Patients receiving lomitapide should also be advised to follow a low fat diet and take fat soluble vitamin supplements. Pharmacokinetic interactions of the microsomal triglyceride transfer protein inhibitor, lomitapide, with drugs commonly used in the management of hypercholesterolemia. Class: Antilipemic Agents, Miscellaneous ATC Class: C10AX12 Chemical Name: N-(2,2,2-Trifluoroethyl)-9-[4-[4-[[[4′-(trifluoromethyl)[1,1′-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate Molecular Formula: C 39 H 37 F 6 N 3 O 2 •CH 4 O 3 S CAS Number: 202914-84-9 Brands: Juxtapid Medically reviewed by Drugs.com on Nov 11, 2021. The generic ingredient in JUXTAPID is lomitapide mesylate. Find information on Lomitapide (Juxtapid) in Davis's Drug Guide including dosage, side effects, interactions, nursing implications, mechanism of action, half life, administration, and more. M1 and M3 do not inhibit CYPs 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4. In vitro Assessment of Drug Interactions. 229960003566 lomitapide Drugs 0.000 title claims abstract description 47; MBBCVAKAJPKAKM-UHFFFAOYSA-N lomitapide Chemical compound-1 . Nitroimidazoles are antibiotics used to treat anaerobic bacterial infections, parasitic infections, and protozoal infections and prevent postoperative infections. Epub 2017 Feb 24. Lomitapide is in a class of medications called cholesterol-lowering medications. Lomitapide: (Major) Decrease the dose of lomitapide by one-half not to exceed 30 mg/day PO if coadministration with spironolactone is necessary. This is not a complete list of side effects and others may occur. Ubrogepant is a substrate of the P-gp drug transporter; lomitapide is a P-gp inhibitor. lomitapide but could be attained near the target level. Many drugs can interact with lomitapide, and some drugs should not be used together. Lomitapide exposure was increased by 164% and C max was 361% higher in patients with moderate hepatic impairment compared to healthy volunteers. Lomitapide is metabolized to its major metabolites, M1 and M3, via cytochrome P450 (CYP) 3A4; also, CYP 1A2, 2B6, 2C8, and 2C19 may metabolize lomitapide to a small extent to M1. Trial Name: lomitapide , AEGR-733, BMS-201038: Novel drug target: Novel Target The potential for drug-drug interactions is also significantly different. You shouldn't take multiple drugs from a single class or that affect the same organ system. No relevant published information exists with the use of lomitapide during breastfeeding. on stable diet and maximally tolerated LDL lowering drugs, with or without apheresis, at baseline. Author Hiroshi Yoshida 1 . It is the first in a new class of lipid-lowering agents to improve . Learn about how they work, usages, side effects, and a list of drugs. Because of a concern with disruption of infant lipid metabolism and possible tumorigenicity, lomitapide should not be used during breastfeeding. Figure 1 Mechanism of action of lomitapide. Author . Nowadays, lomitapide is approved as a first-in-class drug for lowering LDL-C levels in HoFH adults in western countries and Japan, and it is a selective inhibitor of microsomal triglyceride transfer protein (MTP) that transfers triglycerides onto newly synthesized apolipoprotein B leading to the formation of very-low-density lipoprotein (VLDL . This enzyme is responsible for the synthesis of very low-density lipoproteins in the liver and chylomicrons in the intestine. Lomitapide is a CYP3A4 inhibitor and has potential for drug-drug interactions with other CYP3A4 inhibitors and drugs metabolized by CYP3A4, while mipomersen has no known drug-drug interactions. Juxtapid (lomitapide) is an oral prescription drug used to treat a rare genetic condition called homozygous familial hypercholesterolemia (HoFH), which causes very high levels of LDL cholesterol. Lomitapide is not a P-gp substrate. There are currently no generic alternatives to Juxtapid. Lomitapide and mipomersen: twofirst-in-class drugs for reducing low-density lipoprotein cholesterol in patients with homozygous familial hypercholesterolemia. Call your doctor for medical advice about side effects. In press. Brand names: Juxtapid Drug class(es): miscellaneous antihyperlipidemic agents Lomitapide systemic is used in the treatment of:. This study is designed to determine if lomitapide is effective and can be safely administered to paediatric patients with HoFH. The US Food and Drug Administration (FDA) approved . Clinicians should keep their eyes on the results of upcoming studies using new class of drugs to find the best and the optimal treatment modality for patients with dyslipidemia. . Juxtapid (lomitapide) is an expensive drug used in combination with diet to lower blood cholesterol levels in some patients. A First-in-Class Drug, Lomitapide, Tailored to Patients with Homozygous Familial Hypercholesterolemia is Just about Meeting with Good News to Them J Atheroscler Thromb. Drug/Drug Class Hyperlipidemia Agents This criteria was recommended for review by the Vendor Drug Program to ensure appropriate and safe utilization Clinical Criteria Information Included in this Document Juxtapid (Lomitapide) Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria Juxtapid is a drug marketed by Amryt and is included in one NDA. Lomitapide does not induce CYPs 1A2, 3A4, or 2B6. Benzodiazepine Drug Information. Lomitapide is in a class of medications called cholesterol-lowering medications. colesevelam decreases levels of lomitapide by drug binding in GI tract. lomitapide composition, tablet, lomitapide product, methods for analyzing a lomitapide sample composition and for determining an amount of an impurity in a composition sample The present application relates to compositions comprising impurities (eg, carbamate and / or products hydrolysis) in a lomitapide sample and methods for detecting such impurities. Used (as its mesylate salt) as a complement to a low-fat diet and other lipid-lowering treatments in patients with . There are eight patents protecting this drug. Lomitapide can also cause drug-drug interactions and caution should be used in co-administration of lomitapide with other inhibitors or substrates of CYP 3A4, P-glycoprotein substrates and warfarin. This article has been cited by other articles in PMC. It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. This drug is less popular than comparable drugs. The NLM Drug Information Portal gives users a gateway to selected drug information from the National Library of Medicine and other key government agencies. 2010 Feb;13(2):103-11. Therefore, the appropriate combination of lomitapide and other medications (e.g., statins, PCSK9 inhibi-A First-in-Class Drug, Lomitapide, Tailored to Patients with Homozygous Familial Hypercholesterolemia is Just about Meeting with Good News to Them Hiroshi Yoshida Drug Class: Antilipemic Agents It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. You can cancel anytime within the 30-day trial, or continue using Davis's Drug Guide to begin a 1-year subscription ($39.95) lomitapide. Lojuxta is a medicine that contains the active substance lomitapide. Lomitapide is a first-in-class microsomal triglyceride transfer protein inhibitor for the treatment of HoFH. Crossref Medline Google Scholar; 21. It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat). MTP inhibitors in patients at different levels of cardiovascular-disease risk is required before clinical use of this class of drugs may be recommended. It is used together with a low fat diet and other medicines to reduce the level of fats in the blood. Use: Labeled Indications Circulation 2014; 129: 1022-32. colestipol decreases levels of lomitapide by drug binding in GI tract. 2017 Apr 3;24(4):390-392. doi: 10.5551/jat.ED069. It helps limit side effects, predict your response to it, and choose a replacement drug when one doesn't work. Lomitapide (5.6.32) (Juxtapid) is a new, oral lipid-lowering agent for the treatment of familial hypercholesterolemia. The starting oral daily dose is 5 mg once daily, at least 2 h after an evening meal. Lomitapide is used together with a low-fat diet and other treatments (including low density lipoprotein (LDL) apheresis) to lower bad cholesterol levels in the blood. Lomitapide, a microsomal triglyceride transfer protein inhibitor for the treatment of hypercholesterolemia IDrugs. Colchicine: Life-threatening and fatal drug interactions have been reported in patients treated with clarithromycin and colchicine. Lomitapide can cause liver problems. Separate lomitapide and administration of bile acid sequestrants by at least 4 hours; bile acid sequestrants can interfere with the absorption of oral medications. This drug is less popular than comparable drugs. Lomitapide exposure was increased by 164% and C max was 361% higher in patients with moderate hepatic impairment compared to healthy volunteers. There are currently seven HMG-CoA reductase inhibitors (statins) approved for lowering cholesterol levels and they are the first line drugs for treating lipid disorders and can lower LDL-C levels by as much as 60%. Both drugs/classes lower LDL-C by reducing hepatic VLDL production, making them independent of the LDL receptor and thus effective in hoFH. Lomitapide. Lomitapide. It has been tested in clinical trials as single treatment and in combinations with atorvastatin, ezetimibe and fenofibrate.. Use Caution/Monitor. Cambridge, MA 02142 . of . Pharmacotherapy. lomitapide (lom-i- ta-pide ), Juxtapid (trade name) Classification Therapeutic: lipid lowering agents Pharmacologic: temporary class Pregnancy Category: X Indications Adjunctive treatment (with low-fat diet and other lipid-lowering treatments) to ↓ low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non . 218 Hyperlipidemia agents. Juxtapid (lomitapide) is developed and manufactured by Aegerion Pharmaceuticals for the treatment of patients with homozygous familial hypercholesterolemia (HoFH). The new classes of drugs beyond statin could enlighten the improvement for anti-atherosclerosis therapy. It works inhibiting microsomal triglyceride transfer protein. The empirical formula for lomitapide mesylate is C 39 H 37 F 6 N 3 O 2 • CH 4 O 3 S and its molecular weight is 789.8.. Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide is available only under a special restricted distribution program called Juxtapid® REMS program. Serious side effects include problems absorbing certain nutrients, gastrointestinal symptoms, and others. Zernikedreef 8, 2333CL Leiden, the Netherlands., Tel. Whether lomitapide or mipomersen decrease the risk of atherosclerotic cardiovascular disease and premature mortality in patients with FH remains to . Lomitapide is administered orally. In a remarkable turn of events, 2 new first-in-class LDL-lowering drugs were approved within a month of each other: lomitapide in December 2012 and mipomersen in January 2013. MTP inhibitors in patients at different levels of cardiovascular-disease risk is required before clinical use of this class of drugs may be recommended. Correspondence: Dr Robert Rissmann PhD, Centre for Human Drug Research. This review provides an update on data emerging from real-world studies of lomitapide following on from its pivotal phase 3 clinical trial in HoFH. Download the Davis's Drug Guide app by Unbound Medicine. of . In patients with mild hepatic impairment (Child-Pugh class A), lomitapide exposure was increased by ~50% compared to healthy volunteers. Lomitapide is a member of the class of benzamides obtained by formal condensation of the carboxy group of 4'-(trifluoromethyl)biphenyl-2-carboxylic acid with the primary amino group of 9-[4-(4-aminopiperidin-1-yl)butyl]-N-(2,2,2-trifluoroethyl)-9H-fluorene-9-carboxamide. There are currently eight different classes of drugs available for lowering cholesterol levels. • Lojuxta/Juxtapid is a powerful cholesterol-lowering prescription medicine taken alongside a low-fat diet and other lipid-lowering therapies in adult patients with HoFH. Drug/Drug Class Hyperlipidemia Agents This criteria was recommended for review by the Vendor Drug Program to ensure appropriate and safe utilization Clinical Criteria Information Included in this Document Juxtapid (Lomitapide) Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria D09638 Lomitapide mesylate (USAN); Lomitapide mesilate (JAN) Drug groups [BR: br08330] Lomitapide . M1 and M3 do not induce CYPs 1A2, 3A4, or 2B6. Date : of . Important: The information below refers to products available in the United States that contain lomitapide. Lomitapide, sold under the brand name Juxtapid in the US and as Lojuxta in the EU) is a medication used as a lipid-lowering agent for the treatment of familial hypercholesterolemia, developed by Aegerion Pharmaceuticals. 1 Rader DJ, Kastelein JJ. [ 13] Lomitapide is a . More than 49,000 drugs can be searched. What is Lojuxta®/Juxtapid (lomitapide) capsules? Lomitapide does not inhibit CYPs 1A2, 2B6, 2C9, 2C19, 2D6, or 2E1. In vitro transcribed (IVT) mRNA has recently come into focus as a potential new drug class to deliver genetic information. It is available as an oral capsule. Lomitapide undergoes extensive metabolism by the liver. In December 2012, the US Food and Drug Administration (FDA) approved Juxtapid for lipoprotein cholesterol reduction in HoFH patients. Lomitapide (Juxtapid ®) is microsomal triglyceride transfer protein inhibitor Food and Drug Administration (FDA)-approved as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce LDL, total cholesterol, apolipoprotein B, and non- Mipomersen will compete with lomitapide mesylate (JUXTAPID), another recently approved first-in-class orphan drug as an adjunct lipid-reducing agent for patients with HoFH. Drugs are classified for safety and effectiveness reasons. • Lojuxta/Juxtapid is a 'first in class' medicine - a drug that uses a unique mechanism of action. Lomitapide and Mipomersen Two First-in-Class Drugs for Reducing Low-Density Lipoprotein Cholesterol in Patients With Homozygous Familial Hypercholesterolemia March 2014 Circulation 129(9):1022-32 Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder. The dose may be gradually increased after 2 weeks, based upon tolerability and response, up to a maximum daily dose of 60 mg. Lomitapide is both a substrate and inhibitor for CYP3A4 metabolism 5. Lomitapide and mipomersen: two first-in-class drugs for . This drug has twenty-seven patent family members in eighteen countries. Lomitapide a small-molecule, microtonal triglyceride transfer protein (MTP) inhibitor, developed by Amryt Pharma (previously Aegerion Pharmaceuticals, a Homozygous Familial Hypercholesterolemia (HoFH) "In December 2012, the US Food and Drug . Our Juxtapid (lomitapide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Lomitapide (JUXTAPID) is a microsomal triglyceride transfer protein inhibitor and indicated as an adjunct to a low-fat diet and other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia (HoFH). Product(s) containing lomitapide: lomitapide systemic. MTP is involved in the production of VLDL. The sponsor seeks approval for NDA 203-858 with the once daily oral administration of a 5, 10, 20, mg lomitapide dose as an adjunct therapy to a low-fat diet and other lipid-lowering drugs with Juxtapid (lomitapide) is an expensive drug used in combination with diet to lower blood cholesterol levels in some patients. 2. • Immune-mediated hypersensitivity to the HMG-CoA reductase inhibitor drug class (statins) as evidenced by an allergic reaction occurring with at least TWO different statins . Select Try/Buy and follow instructions to begin your free 30-day trial. Lomitapide has been approved for use in adult patients with HoFH in the European Union (EU) and European Economic Area (EEA), United States of America (USA), Israel, Argentina, Canada, Colombia, and Japan. Davis Drug Guide PDF. The drug is 99.8% plasma-protein bound. There are two drug master file entries for this compound. Benzodiazepines are . Call your doctor at once if you have nausea, vomiting, upper stomach pain, tiredness, flu-like symptoms, dark urine, or jaundice (yellowing of the skin or eyes). Liao W, Hui TY, Young SG, Davis RA. Lomitapide. Concomitant use may significantly increase the serum concentration of lomitapide. Some classes of drugs shouldn't be used together. Call your doctor at once if you have nausea , vomiting , upper stomach pain, tiredness, flu-like symptoms, dark urine, or jaundice (yellowing of the skin or eyes). In patients with mild hepatic impairment (Child-Pugh class A), lomitapide exposure was increased by ~50% compared to healthy volunteers. 2189 Others. Juxtapid (lomitapide) is a prescription medication used to reduce LDL (bad) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C). Patients received lomitapide as add-on therapy at an individually defined maximum tolerated dose between 5 and 60 mg once daily for 78 weeks (weeks 0 to 26 was the efficacy phase, weeks 26 to 78 was the safety phase). Participation in an interventional clinical study within 6 weeks for a statin therapy or within 6 months for any other unapproved therapy. Lomitapide interacts with numerous agents such as cytochrome P450 3A4 inhibitors, warfarin, select statins, P-glycoprotein substrates, and bile acid sequestrants, while mipomersen has minimal clinically relevant drug-drug interactions. Lomitapide is an inhibitor of MTP, an enzyme located in the endoplasmic reticulum of hepatocytes and enterocytes. Indications. : +31 (0)71 524 6438, Fax: +31 (0)71 524 6499, E-mail: ln.rdhc@nnamssirr. Summary of Use during Lactation. General. Lomitapide inhibits CYP3A4. Telephone: 617-500-7795 . Use: Labeled Indications Lomitapide, a microsomal triglyceride transfer protein inhibitor for the treatment of hypercholesterolemia IDrugs. Lomitapide mesylate is a new molecular entity and is the first in the class of microsomal triglyceride transfer protein inhibitor. Clarithromycin is a strong CYP3A4 . DG00362 Lomitapide D09637 Lomitapide Target-based classification of drugs [BR:br08310] Not elsewhere classified Organismal systems Digestive system MTTP D09637 Lomitapide (USAN/INN) Drug metabolizing enzymes and transporters [br08309.html] Drug metabolizing enzymes D09637 Drug groups [BR:br08330] Metabolizing enzyme substrate DG01633 CYP3A . Any patient who is unable to avoid treatment with strong or moderate cytochrome P450 3A4 (CYP3A4) inhibitors, or other drugs contraindicated for use with lomitapide during the study. (Note that non-subscribers to the journal will only be able to see an abstract of the article.) Lomitapide can cause liver problems. JUXTAPID (lomitapide) capsules . Many drugs can interact with lomitapide, and some drugs should not be used together. High Cholesterol; High Cholesterol, Familial Homozygous Drug Class: Microsomal Triglyceride Transfer Protein Inhibitor (MTP-I) Aegerion Pharmaceuticals, Inc. (Aegerion) 101 Main Street Suite 1850 . There are currently no generic alternatives to Juxtapid. 21 Cardiovascular agents. Action. Received 2015 Jan 20; Accepted 2015 Feb 11. Hypolipidemic and antihyperlipidemic drugs are agents that decrease lipid concentrations in blood. 2010 Feb;13(2):103-11. You may report side effects to FDA at 1-800-FDA-1088. This review provides an update on data emerging from real-world studies of lomitapide following on from its pivotal phase 3 clinical trial in HoFH. Serious side effects include problems absorbing certain nutrients, gastrointestinal symptoms, and others. Uses for lomitapide. The use of clarithromycin with lomitapide, simvastatin, lovastatin, ergotamine, or dihydroergotamine is contraindicated [see Contraindications (4.5, 4.6) and Drug Interactions ]. Author . Advances in addressing the inherent challenges of this drug class, … Click on the DRUG REVIEW ARTICLE tab (above) to see a review of lomitapide in the Taylor & Francis journal Expert Opinion on Drug Safety. RISK EVALUATION AND MITIGATION STRATEGY (REMS) Reference ID: 3236194 Juxtapid (lomitapide) is a prescription medication used to reduce LDL (bad) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C). Lomitapide treatment is started with a daily oral dose of 5 mg, taken 2 or more hours after the evening meal 5. Venetoclax: (Major) Reduce the dose of venetoclax by at least 50% and monitor for venetoclax toxicity (e.g., hematologic toxicity, GI toxicity, and tumor lysis syndrome) if coadministered with lomitapide due to the potential for increased venetoclax exposure. D09638 Lomitapide mesylate (USAN) Therapeutic category of drugs in Japan [BR: br08301] 2 Agents affecting individual organs. Lomitapide. Lomitapide is in a class of medications called cholesterol-lowering medications. Lomitapide is a first-in-class microsomal triglyceride transfer protein inhibitor for the treatment of HoFH. colestipol. Lomitapide(Juxtapid) generic is an Orphan drug, used as an adjunct to a low-fat diet and other lipid-lowering treatments in the treatment of hypercholesterolemia. It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. 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