dietetic food and substances adapted for medical or veterinary use, food for babies; On Monday, October 5, 2020, Amgen Inc. filed a United Kingdom trademark application Lumakras (sotorasib) is a KRAS G12C inhibitor for the treatment of patients with KRAS G12C -mutated locally advanced or metastatic non- small cell lung cancer (NSCLC), following at least one prior systemic therapy. Carton containing one bottle of 240 tablets with child-resistant closure, NDC 55513-488-24. This program provides information on cost assistance for Lumakras. Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H. Liver problems: LUMAKRAS may cause abnormal liver blood test results. material for stopping teeth, dental wax; Companies Intelligence Amgen Inc Free Profile >> It is not known if LUMAKRAS will harm your unborn baby. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. have lung or breathing problems other than lung cancer. (NSCLC). Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LUMAKRAS if you develop side effects. preparations for destroying vermin; are pregnant or plan to become pregnant. The LUMAKRAS mark is filed in the category of Do not use any other liquids. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). Lumakras 10258575 : 120 mg/240 tabs : 55513-0488-24 : Amgen Inc. In Q2 2022, Amgen recorded overall revenues of $6.59 billion, a 1 percent increase compared to $6.53 billion in Q2 2021. It is not known if LUMAKRAS passes into your breast milk. LUMAKRAS can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis. Check out similar drugs: Imatinib Mesylate Uses: Treats leukemia and other kinds of cancer and related diseases. 120 mg. Each tablet contains 120 mg sotorasib. The recommended dosage of Lumakras is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity. organizations. are pregnant or plan to become pregnant. It is not known if LUMAKRAS will harm your unborn baby, For US Audiences Do you wish to Registered. Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H2 blockers during treatment with LUMAKRAS. Lumakras may cause inflammation of the lungs that can lead to death. Manufacturer: Amgen. amgen has announced new combination study results from the phase ib codebreak 101 study, a comprehensive global master protocol trial evaluating the safety and efficacy of lumakras (sotorasib), the first and only approved kras g12c inhibitor, in more than 10 different investigational combination regimens for the treatment of patients with kras A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. Pronunciation of LUMAKRAS with 3 audio pronunciations. On TrademarkElite platform, every application is filed by licensed trademark lawyers. . (Credit: Coolcaesar/Wikipedia.) The average retail price for Lumakras costs over $17,800 for a one-month supply, even with a Lumakras coupon. Tell your healthcare provider or get emergency medical help right away if you have new or worsening shortness of breath, cough, or fever. 1-833-863-5483 (M-F, 9AM-5PM PST) dietetic food and substances adapted for medical or veterinary use, food for babies; A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased aspartate aminotransferase (AST); 6% were Grade 3 and 0.6% were Grade 4. Do not take 2 doses at the same time to make up for a missed dose, If you vomit after taking a dose of LUMAKRAS, do not take an extra dose. Get Best Price. Lumakras (sotorasib) is a brand-name prescription medication. SOTORASIB targets proteins in cancer cells and stops the cancer cells from growing. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met. If you cannot swallow LUMAKRAS tablets whole1: Place your daily dose of LUMAKRAS in a glass of 4 ounces (120 mL) of noncarbonated room temperature water without crushing the tablets. Major efficacy outcomes in patients with 1 measurable lesion (BICR according to RECIST v1.1; n=124) were objective response rate (36% [95% CI: 28-45]; CR . Rinse the glass with an additional 4 ounces (120 mL) of water and drink to make sure that you have taken the full dose of LUMAKRAS. amgen took on one of the toughest challenges of the last 40 years in cancer research by developing lumakras/lumykras, a kras g12c inhibitor. The lowest GoodRx price for the most common version of Lumakras is around $18,694.66, 9% off the average retail price of $20,678.68. Pharmaceuticals, medical and veterinary preparations; Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS, a KRAS G12C inhibitor. 90+% of FDA specialty approvals launched through limited distribution in 2011.. and that trend continues in 2021. You can create a free account on TrademarkElite.com, and Ask your healthcare provider if you are not sure. Only, Support The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. There is currently no therapeutically equivalent version of Lumakras available in the United States. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. that has spread to other parts of the body or cannot be removed by surgery. Difficult. Lumakras' approval was a milestone in researchers' efforts to target KRAS, which is frequently mutated in lung, colon and pancreatic cancers and for decades eluded attempts to block it with drugs. LUMAKRAS is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery, and whose tumor has an abnormal KRAS G12C gene, and who have received at least one prior treatment for their cancer.Your healthcare provider will perform a test to make sure that LUMAKRAS is right for you. Indications: Lumakras (Sotorasib) is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic thera Manufacturer: Amgen Price: Welcome to inquiry UNITED STATES. 1 lumakras has demonstrated a positive benefit-risk profile. Call your doctor for medical advice about side effects. disinfectants; removed by surgery, and whose tumor is KRAS G12C positive, and who have received at 2. For people living with non-small cell lung cancer Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H. Liver problems: LUMAKRAS may cause abnormal liver blood test results. Lung or breathing problems: LUMAKRAS may cause inflammation of the lungs that can lead to death. As an intellectual property attorney, I understand how important it is to have high quality legal representation for protecting valuable brand names. It is not known if LUMAKRAS is safe and effective in children. Missing a deadline could result in your trademark becoming abandoned. Vegzelma is an infused therapy administered by a healthcare professional. [6] [7] Call your doctor right away if you think you've taken too much Lumakras. Certain of our distributors, customers and payers have . In addition to dose interruption or reduction, 5% of patients received corticosteroids for the treatment of hepatotoxicity. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). 1 lumakras/lumykras has demonstrated a positive benefit-risk profile with rapid, deep, and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) plasters, materials for dressings; The Construction Market size was valued at USD 7.28 trillion in 2021 and is predicted to reach USD 14.41 trillion by 2030 with a CAGR of 7.3% from 2022-2030. . Get this drug now Sprycel You should use your clinical judgment to determine which product may be appropriate in each instance. Information, Important These are not all the possible side effects of LUMAKRAS. Lumakras Amgen First Step Co-Pay Card Program: Eligible commercially insured patients may pay $0 for their 1st dose or cycle then pay as little as $5 for subsequent doses or cycles up to the brand program benefit maximum; currently patients are automatically re-enrolled in the program for the next year; for additional information contact the program at 888-427-7478. 1 lumakras/lumykras has demonstrated a positive. - The decision to approve this indication has been made on the basis of the . LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see DOSAGE AND ADMINISTRATION], who have received at least one prior systemic therapy.. a website operated by a third party. Two weeks after Amgen reported the top-line result of its CodeBreak-200 trial of Lumakras in lung cancer, the. continue? who have received at least one prior treatment for their cancer. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lumakras. 975 E. Dava Dr, Tempe, AZ 85283 Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Class 005 (sotorasib) TABLETS. Class 005 Trademark Elite is run by highly experienced trademark counsel who provide personalized attention and outstanding client service. An Amgen spokesperson dismissed the concerns,. Lumakras (sotorasib) was approved for the following therapeutic use: Lumakras has provisional approval in Australia for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.. You should use your clinical judgment to determine which product may be appropriate in each instance. The LUMAKRAS is under the trademark classification: Pharmaceutical Products; The LUMAKRAS trademark covers Pharmaceutical preparations for use in the prevention of amyloidosis, metabolic diseases and disorders, lupus, and inflammation and autoimmune . Pharmaceutical preparations for use in the prevention of amyloidosis, metabolic diseases and disorders, lupus, and inflammation and autoimmune diseases and disorders; pharmaceutical preparations for use in the treatment of cancer, oncology, tumors, solid and hematological tumors and growths, hematological and hemolytic diseases and disorders, including bone, joint, vertebral column, intestine, colon, skin, lung, eye, breast, ovary, cervix, stomach, bladder, kidney, head, brain, neck, and blood diseases and disorders; pharmaceutical preparations for use in the treatment of amyloidosis, metabolic diseases and disorders, lupus, and inflammation and autoimmune diseases and disorders; pharmaceutical preparations for use in the treatment of solid tumors and growths, hemolytic diseases and disorders, amylodiosis, metabolic diseases and disorders, lupus, and inflammation and autoimmune diseases and disorders. Video Tutorials Feel free to visit or contact us for any question. We don't currently offer Lumakras. LUMAKRAS (sotorasib) Patient Information. Available for Android and iOS devices. . that has spread to other parts of the body or cannot be removed by surgery. The FDA recently approved the fourth biosimilar to Genentechs Avastin, Vegzelma (bevacizumab-adcd) from Celltrion USA. sanitary preparations for medical purposes; Lumakras here! There were 105 press releases posted in the last 24 hours and 200,540 in the last 365 days. Please confirm your email to receive free alerts. Before taking LUMAKRAS, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Thousand Oaks, CA: Amgen 2021. Take LUMAKRAS exactly as your healthcare provider tells you to take it. (See Below) We hope that more manufacturers similarly follow Amgens lead in publishing such a list. a website operated by a third party. Compare KRAS inhibitor. It is indicated in the treatment of adult patients with KRAS G12C mutant non small cell lung cancer. , All rights reserved. No income eligibility requirement. Take LUMAKRAS 1 time each day, at about the same time each day. IndiaMART. Do you wish to If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. It is not known if LUMAKRAS will harm your unborn baby. Lumakras is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC): that has spread to other parts of the body or cannot be removed by surgery, and whose tumor has an abnormal KRAS G12C gene, and who have received at least one prior treatment for their cancer. Sotorasib. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Class 005 The Amgen FIRST STEP Program can help eligible commercially insured patients meet their deductible, co-insurance, or co-payment. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Drug class: miscellaneous antineoplastics. who have received at least one prior treatment for their cancer. LUMAKRAS is a medicine widely used to treat adults with non-small cell lung cancer (NSCLC) that has enhanced to other parts of the body or is resistant to surgery. That is why I chose to have Trademark Elite to register the trademark for my award-winning law blog. that has spread to other parts of the body or cannot be removed by surgery, and, whose tumor has an abnormal KRAS G12C gene, and. A total of 18% of patients who received LUMAKRAS had increased alanine aminotransferase (ALT)/increased Mutant KRAS discovered in 1982 but was not considered a druggable target until the mid-2010s. LUMAKRAS in Combination with Trametinib (Abstract LBA6580) . around your LUMAKRAS trademark. Lumakras coupons may also be available to many patients. Take Lumakras at the same time each day with or without food [see Clinical Pharmacology (12.3)]. Do not change your dose or stop taking LUMAKRAS unless your healthcare provider tells you to. TrademarkElite.com is operated by The Ideas Law Firm, PLLC (the United States-based law firm). Licensed lawyer works on your case; conducts trademark search and Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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