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Chronic Fibrosing Interstitial Lung Disease With A Progressive Phenotype, Systemic Sclerosis-Associated Interstitial Lung Disease, colony-stimulating factor 1 receptor (CSF1R). Nintedanib can cause birth defects or death to an unborn baby. Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Your doses may be delayed if you have certain side effects. Ask your pharmacist any questions you have about refilling your prescription. Previously, IPF has been managed using immunosuppressive therapy; however, it has been shown that this is associated with increased mortality. Brand name: Ofev have had recent surgery in your stomach (abdominal) area. Avoid smoking while taking this medicine, or try to quit before you start this treatment. The safety and tolerability of nintedanib in the treatment of idiopathic pulmonary fibrosis. However, based on the way it works and results from animal studies, this drug is likely to harm a fetus if used during pregnancy. This content does not have an English version. The annual rate of decline in FVC was consistent irrespective of age, race and FVC % predicted at the start of INPULSIS-ON. If you drink alcohol, talk with your doctor about how much (if any) is safe to drink while taking Ofev. * This is a partial list of mild side effects from Ofev. Early diagnosis and proper care are critical to helping people treat their condition. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Generics tend to cost less than brand-name drugs. N Engl J Med 2005; 353: 22292242. government site. Int J Mol Sci. Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF; scarring of the lungs with an unknown cause). It can cause symptoms such as: Youll likely have other symptoms with systemic sclerosis as well. Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. If you become pregnant while taking Ofev, tell your doctor right away. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Anaprox, Naprelan); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); erythromycin (E.E.S., Ery-Tab, Eryc); ketoconazole; laxatives; oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone; phenytoin (Dilantin, Phenytek); pirfenidone (Esbriet); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); or stool softeners. To help make sure that you dont miss a dose, try using a medication reminder. Please enable it to take advantage of the complete set of features! SOURCE Boehringer Ingelheim Pharmaceuticals, Cision Distribution 888-776-0942 Ofev is used in people with diseases that cause scar tissue (fibrosis) to form deep within the lungs. About the Disease Disease Progression The Food and Drug Administration (FDA) approves prescription drugs such as Ofev to treat certain conditions. These findings are also consistent with post-marketing surveillance data collected in the US during the first year following the launch of Ofev as a treatment for IPF. Pirfenidone is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). The expiration date helps guarantee that the medication is effective during this time. Pirfenidone, a well-known anti-fibrotic drug already approved outside the U.S., and nintedanib, a tyrosine kinase inhibitor, both became available internationally in October 2014. If youre pregnant or plan to become pregnant, talk with your doctor about alternative treatment options for your lung condition. Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink, Ofev Nintedanib: MedlinePlus Drug Information It is not known if nintedanib passes into your breast milk. How Viagra became a new 'tool' for young men, Ankylosing Spondylitis Pain: Fact or Fiction, Ofev use for idiopathic pulmonary fibrosis, Nonsteroidal anti-inflammatory drugs (NSAIDs), gastrointestinal perforation (hole or tear in the wall of your stomach or intestine), New clues to slow aging? Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If your local pharmacy doesnt have these options, your doctor or pharmacist may be able to direct you to one that does. If you miss a dose, skip the missed dose and take your next dose as usual when scheduled. To treat interstitial lung disease * with scarring, the usual dosage of Ofev is 150 mg two times per day. HHS Vulnerability Disclosure, Help Epub 2021 Mar 25. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ofev only for the indication prescribed. Wash your hands well right away if your skin comes in contact with the content inside the capsules. Store nintedanib at room temperature between 68F to 77F (20C to 25C). 2022 Sep 2;13(9):760. doi: 10.1038/s41419-022-05207-8. ", Dr. Susanne Stowasser, Associate Head of Medicine Respiratory at Boehringer Ingelheim said: "The INPULSIS-ON results provide valuable insights about the long-term safety and efficacy of Ofev in IPF and supply further evidence of its positive impact on the lives of people living with this disease." Most of these side effects may go away within a few days or a couple of weeks. Fill Material: triglycerides, hard fat, lecithin. Ofev helps to slow down the formation of scar tissue in your lungs. The scientific evidence shows that nintedanib is effective and well tolerated for the treatment of IPF in mild, moderate and severe stages of the disease. 8600 Rockville Pike Take nintedanib exactly as directed. Nintedanib can cause birth defects or death in an unborn a baby. The capsules should be swallowed whole with a drink. Ofev is usually taken 2 times per day, every 12 hours. It can lead to fatal complications. Your doctor will tell you how much of this medicine to take and when to take it. are pregnant or plan to become pregnant. Keep all appointments with your doctor and the laboratory. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. As both medications are intended to slow disease progression, perhaps measured over months or years, drug adherence remains an important issue, particularly as clinical symptoms such as dyspnea or cough may not be expected to significantly improve.