Mipomersen is contraindicated in patients with moderate or severe hepatic impairment (based on Child-Pugh category B or C) or active hepatic disease, including unexplained persistent elevations of serum transaminases. It is used to treat familial hypercholesterolemia, a hereditary disorder. Spinraza is a brand-name prescription drug. The 20mer ASO with all PS internucleotide linkages has the following sequence: Kastle Therapeutics has acquired global rights to develop and commercialize the marketed drug Kynamro ® (mipomersen sodium) injection from Ionis Pharmaceuticals for up to $95 million-plus. Date. Brand Name(s): Kynamro . 04HQ3922 R10/21 Blue Cross and Blue Shield of Louisiana is an independent licensee of t he Blue Cross and Blue Shield Association A disease or disorder is defined as rare in Europe when it affects less than 1 in 2,000 citizens. DISEASE CATEGORY DRUG CATEGORY BRAND NAME GENERIC NAME Multiple Sclerosis Anti-CD52 Lemtrada Alemtuzumab Movement Disorders Multiple Sclerosis Dopamine Precursor CD20-Directed Cytolytic . 5. Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance. Raal JF, Santos RD, Blom DJ, et al. Medications with generic name beginning with the letter 'M' (MIPOMERSEN SODIUM). Mipomersen . : 203568Approval Date: 1/29/2013. Mipomersen Injection Generic name: Pronounced as (mi'' poe mer' sen ) Brand names Kynamro® Click on drug name to hear pronunciation Medical Content Reviewed By HelloPharmacist Staff Last Revised - 01/15/2017 IMPORTANT WARNING Mipomersen injection may cause liver damage. Antisense gene therapy is a gene silencing technique in which, When the genetic sequence of a particular gene is known to be causative of a particular disease, it is possible to synthesize a strand of nucleic acid (DNA, RNA or a chemical analogue) that will bind to the . What is mipomersen (Kynamro)? It is usually injected once a week. Mechanism of Action:1,2,3,4,Mipomersen sodium is an oligonucleotide inhibitor of apo B-100 synthesis, inhibiting synthesis of apo B by sequence-specific binding to its messenger ribonucleic acid (mRNA) through enzyme-mediated pathways or disruption of mRNA function through binding alone. of . There are genetic risk factors. Alternative Names: ISIS-301012; Kynamro; Mipomersen sodium - Kastle Therapeutics. In case of any doubt consult your doctor or pharmacist. USES: It is used for treating pain and fever. Common adverse reactions include injection site reactions, flu -like symptoms, nausea , headache , and elevations in serum transaminases , specifically ALT . Built for Longevity - Great brand names grow with your . Documentation of recent (within the last 60 days) LDL-C ≥ 70 mg/dL; 5. Description. Brand Names: US. 4. The brand name, Supprelin® LA, has been removed from HCPCS code J1675. Important: The information below refers to products available in the United States that contain mipomersen. HOW SUPPLIED . It reduces blood levels of "bad" cholesterol, such as low-density lipoprotein (LDL), apolipoprotein-B (apo-B), or non-high-density lipoprotein (non-HDL). How should this medicine be used? The FDA has granted mipomersen Orphan Drug designation for the treatment of patients with HoFH. Created with ChemDoodle and Adobe Illustrator CC 2017. Date. As of June 2021, 15 drugs were approved. Brand name: Macugen. Mipomersen is a cholesterol -lowering medication. . Charges ranging from $4-$15 for a 30-day or 90-day supply, but $4 Generics is a common name for this type of program. It works by preventing certain fatty substances from forming in the body. Mipomersen. Mipomersen.svg. Page 4 of 9. Member has been adherent for at least the last 4 months to maximally tolerated 3: mipomersen These drugs are called "orphan" because under normal market conditions the pharmaceutical industry has little interest in developing and marketing products intended for only a small number of patients. A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy - PA.CP.PMN.53 or evidence of coverage documents. Juxtapid (lomitapid), Kynamro (mipomersen), or Repatha (evolocumab) Mipomersen . Mipomersen is an oligonucleotide drug used for the treatment of homozygous familial hypercholesterolemia. FDA approval: 2004-12-17. Pharmacy retailers' prescription programs which offer generic medications for a discounted price. Mipomersen (Kynamro) - Uses, Dose, Side effects, MOA, Brands Mipomersen is a novel antisense Oligonucleotide Inhibitor that is indicated for the treatment of familial homozygous hypercholesterolemia who have an inadequate response to statins and PCSK-9 inhibitor therapy ( Evolocumab ). In July 2011, Genzyme Corporation submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for the 200 mg weekly dose of mipomersen for the treatment of HoFH and severe HeFH. Mipomersen was developed by Ionis Pharmaceuticals as a novel ASO inhibitor for the cure of HoFH (Crooke et al., 2005). Mipomersen (brand name Kynamro), the second and latest antisense-based drug, is used for lowering LDL-cholesterol in patients with hypercholesterolemia (Hair, Cameron, & McKeage, 2013; Ricotta . Mipomersen Dupilumab Benralizumab Antilipemic PCSK9 Inhibitor Repatha Evolocumab Anemia Antilipemic Anemia Anemia Anemia Anemia Activin Receptor Ligand Trap . Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. 7.5 Mechanism of Action Mipomersen binds to the mRNA that codes for apoB-100. High Cholesterol; High Cholesterol, Familial Homozygous PARACETAMOL (Acetaminophen) CLASSIFICATION: Analgesics and Antipyretics. Mipomersen will be marketed under the brand name Kynamro® and the launch is planned for 2013. That's why the .com is the world's default domain. Buy Profile. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. Treatment for macular degeneration (wet AMD). Advertisement Why is Mipomersen Injection Prescribed? Mipomersen - Kastle Therapeutics. It's used together with other cholesterol-lowering medications and diet. GoodRx's cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies. PRODUCTS AFFECTED: Kynamro (mipomersen) DRUG CLASS: Antihyperlipidemics -Misc HOW SUPPLIED . Either increases toxicity of the other by Other (see comment). The mipomersen clearance follows a 9-6 vote in favor of the drug's approval by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee this past October. In January, the Food and Drug Administration approved the first RNAi drug, Kynamro (brand name mipomersen sodium), to help people with an extreme type of high cholesterol. Mipomersen is indicated in patients with homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering medications. The mipomersen clearance follows a 9-6 vote in favor of the drug's approval by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee this past October. 12/01/2016 A treatment not a cure or preventative. Efalizumab (Raptiva) (C9399, J3590) has been end-dated effective 03/17/2017. Mipomersen is a cholesterol-lowering medication. Now the current study on . mipomersen, baclofen. Description Mipomersen (Kynamro®) is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis. English: Complete sequence of of mipomersen (brand name Kynamro) — an antisense oligonucleotide approved for the treatment of homozygous familial hypercholesterolemia (HoFH). BIIB067 is a second-generation antisense oligonucleotide (ASO) targeting the mRNA for superoxide dismutase 1. A business name with a matching .com domain - known as a brandable domain - is a valuable asset. This drug may cause liver problems in some patients. Mipomersen injection is in a class of medications called antisense oligonucleotide (ASO) inhibitors. 2010;375:998-1006. This drug lowers cholesterol levels by removing a main part of "bad" cholesterol. Talk with the doctor. Mipomersen (Brand name: Kynamro) - Manufactured by Kastle Therapeutics, LLC FDA-approved indication: Adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial . English: Skeletal formula of mipomersen (as sodium salt; brand name Kynamro) — an antisense oligonucleotide approved for the treatment of homozygous familial hypercholesterolemia (HoFH). The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high. Mipomersen, an apolipoprotein B Synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomized, double-blind, placebo-controlled trial. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs. Mipomersen (brand name Kynamro), the second and latest antisense-based drug, is used for lowering LDL-cholesterol in patients with hypercholesterolemia (Hair, Cameron, & McKeage, 2013; Ricotta . (Indications) This medication is a cholesterol-reducing agent. Your purchase entitles you to full access . Read the side effects of Mipomersen Injection as described in the medical literature. Price : $50 *. KYNAMRO (mipomersen sodium) Injection is a sterile, preservative-free, clear, colorless to slightly yellow, aqueous solution for subcutaneous injection. Trade Names/Brand Names of Mipomersen Injection International - Kynamro. transaminases, and in . Cost: USD 46,000 per year. MIPOMERSEN (mi" poe mer' sen) is used in combination with diet and other medicines to lower blood cholesterol levels in patients with a genetic disorder that results in high blood cholesterol levels. Brand Names Kynamro Generic Name Mipomersen DrugBank Accession Number DB05528 Background Mipomersen sodium, which was known as the investigational drug, isis-301012, is the salt form of a synthetic phosphorothioate oligonucleotide. Name: Tofersen Synonyms: BIIB067, Ionis-SOD1Rx, ASO1 Therapy Type: DNA/RNA-based Target Type: Other Condition(s): Amyotrophic Lateral Sclerosis U.S. FDA Status: Amyotrophic Lateral Sclerosis (Phase 3) Company: Biogen, IONIS Pharmaceuticals Background. There is a Black Box Warning for this drug as shown here . 6. baclofen. Mipomersen. How administered: intravitreal (eye) injection, every six weeks. It's FDA-approved to treat spinal muscular atrophy (SMA) in adults and children.. SMA is a rare genetic disorder* that affects the central nervous . . 04HQ3922 R01/19 Blue Cross and Blue Shield of Louisiana is an independent licensee of t he Blue Cross and Blue Shield Association Mipomersen is a prescription medication used to lower cholesterol in people with homozygous familial hypercholesterolemia (HoFH, a hereditary disorder that causes high cholesterol levels). We do not sell or distribute actual drugs. COMMON BRANDS Monitor therapy. This information from Lexicomp ® explains what you need to know about this medication, including what it's used for, how to take it, its side effects, and when to call your healthcare provider.. The drug is delivered by subcutaneous injection. Generally it can be taken orally. For drug companies, the extremely high . For members on statin therapy, both of the following (a and b): a. Kynamro is prescribed in conjunction with a statin at the maximally tolerated dose; b. Genzyme and Isis submit European MAA for mipomersen: Cambridge, Massachusetts Saturday, July 30, 2011, 13:00 Hrs [IST] Genzyme, a Sanofi company and Isis Pharmaceuticals Inc. announced that Genzyme has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe . Kynamro (mipomersen) is an injectable medication that helps lower cholesterol levels in people with a condition called homozygous familial hypercholesterolemia (HoFH). Prevalence: 2,400 per 100,000 (500 times as prevalent as SCA). Created with ChemDoodle and Adobe Illustrator CC 2017. Kynamro belongs to a group of drugs called antisense oligonucleotides. Risk C: Monitor therapy. It is marketed under the brand name Kynamro in the United States, and the FDA label includes a black box warning of hepatoxicity. *generic drug is not included in the Specialty Pharmacy Program. Mipomersen belongs to a group of drugs called antisense oligonucleotides. Mipomersen is contraindicated in patients with moderate or severe hepatic impairment (based on Child-Pugh category B or C) or active hepatic disease, including unexplained persistent elevations of serum transaminases. Mipomersen, known by the brand name Kynamro, will be marketed in the U.S. by Genzyme, a Sanofi company. Kynamro (Mipomersen) Mipomersen, with a market name of Kynamro, is useful as an adjunct therapy for homozygous familial hypercholesterolemia (HoFH) (Raal et al., 2010; Mcgowan et al., 2012; Stein et al., 2012; Thomas et al., 2013). Provided the necessary approvals are granted, mipomersen would be marketed under the brand name KYNAMRO™, the name that has been submitted to health authorities for the investigational agent. Overview. COMMON BRAND NAMES. COMMON BRAND NAMES. Use Caution/Monitor. Most of our discount and coupon prices are based on contracts between a pharmacy (or pharmacy purchasing group) and a Pharmacy Benefit Manager (PBM), who . Appendices/General Information Appendix A: Abbreviation/Acronym Key ALT: Alanine transaminase mipomersen, azathioprine. Mipomersen. Specifically, elevations in the liver enzymes, i.e. Mipomersem has a very long half life of 1-2 months. Mipomersen is a lipid-lowering medication that is FDA approved for the {{{indicationType}}} of hypercholesterolemia. Kynamro is a prescription medication used to lower cholesterol in people with homozygous familial hypercholesterolemia (HoFH, a hereditary disorder that causes high cholesterol levels). Specifically, elevations in the United States that contain mipomersen, has been removed from HCPCS code J1675 comment. Drug CLASS: Antihyperlipidemics -Misc HOW SUPPLIED is planned for 2013 2,400 per (... Used for other purposes ; ask your health care provider or pharmacist the FDA label includes a Box! 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