Ofev can cause birth defects or death in an unborn baby. For more information about the possible side effects of Ofev, talk with your doctor or pharmacist. It can also help prevent acute flare-ups. Everything you need to know about mesothelioma: Esbriet, Actemra, tocilizumab, pirfenidone, nintedanib, Actimmune, interferon gamma-1b. Bethesda, MD 20894, Web Policies For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. Nintedanib may cause other side effects. Detailed Nintedanib dosage information What are the side effects of nintedanib? For more information and to find out if youre eligible, call 866-673-6366 or visit the program website. For instance, you can take one capsule of OFEV in the morning and one in the evening. Its not currently available in generic form. As with most drugs, some people can have an allergic reaction after taking Ofev. Last updated on Sep 20, 2022. Dosage form: capsule Nintedanib inhibits a variety of receptor and nonreceptor tyrosine kinases these are signaling proteins that work as an ON/OFF switch in many cell-to-cell communications. Licensed from: Boehringer Ingelheim International GmbH. Before you take Ofev, tell your doctor if you have: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. John's wort. Ask your pharmacist any questions you have about refilling your prescription. Its available in two strengths: 100 milligrams (mg) and 150 mg. For information about the effectiveness of Ofev, see the Ofev uses section below. When pooling data for two of the pirfenidone trials, 21 percent of participants still had FVC decline greater than 10 percent while on therapy. If you would like to notify the FDA about a side effect youve had with Ofev, you can do so through MedWatch. Research continues to optimize selection of the target population that will most benefit and experience the fewest side effects. For more information, ask your doctor or pharmacist. With autoimmune conditions, your immune system mistakenly attacks your bodys own healthy cells. To read more about this, see the Common questions about Ofev section above. Serious side effects from Ofev arent common, but they can occur. Bronchiectasis is a lung condition that causes persistent cough and excess phlegm. tell your doctor what herbal products you are taking, especially St. John's wort. They may talk to you about continuing nintedanib after finishing treatment with docetaxel. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. About the INPULSIS-ON trial INPULSIS-ON was an open-label extension trial initiated in 2012, evaluating the tolerability, safety and efficacy of Ofev in patients with IPF. The Food and Drug Administration (FDA) approves prescription drugs such as Ofev to treat certain conditions. Researchers explore whether senescence-associated secretory phenotype (SASP) is a potential driver of age-related dysfunction, Updates in interstitial lung disease: Current facets of anti-fibrotic therapy, Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Graduate Medical Education, Mayo Clinic School of Continuous Professional Development, Financial Assistance Documents Minnesota, Pulmonary, Critical Care, and Sleep Medicine, Anti-fibrotic therapy in the treatment of IPF: Ongoing concerns and current practices. Scientists use genetic rewiring to increase lifespan of cells, Beyond amyloid and tau: New targets in developing dementia treatments, Napping longer than 30 minutes linked to higher risk of obesity and high blood pressure, Activity 'snacks' could lower blood sugar, complication risk in type 1 diabetes, In Conversation: Investigating the power of music for dementia, interstitial lung disease associated with systemic sclerosis (a condition that causes thickening and scarring of tissues throughout your body), Blood clot in an artery, which could cause a, pain or pressure in your jaw, neck, back, shoulder, or arm, weakness or numbness on one side of your body. Do not chew, crush, or open capsules. Talk with your doctor about using a form of birth control that isnt affected by vomiting or diarrhea, such as an injection or implant. If its not managed, this can lead to dehydration (low level of fluid in your body). FVC (forced vital capacity) is a lung function test that measures the total amount of air exhaled during the forced expiratory volume (FEV) test. How long does it take for Ofev to start working? Ofev comes as a capsule that you take by mouth. Nintedanib inhibits the following RTKs: Research has shown that nintedanib starts to improve FVC within 6 weeks of starting the medication. If you miss a dose, skip the missed dose and take your next dose as usual when scheduled. Keep this medication in the container it came in, tightly closed, and out of reach of children. HHS Vulnerability Disclosure, Help * Sex and gender exist on spectrums. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. Viruses. You should not start taking nintedanib until a pregnancy test has shown that you are not pregnant. Nintedanib is a drug that has been approved by the FDA for some types of Interstitial lung disease (ILD) which have symptoms of shortness of breath, a dry cough, feeling tired and chest discomfort. Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Please enable it to take advantage of the complete set of features! Take nintedanib exactly as directed. Ofev is recommended as a treatment option for idiopathic pulmonary fibrosis in guidelines from the American Thoracic Society. People with IPF who are prescribed nintedanib will typically take one 150 mg tablet twice daily with food. Take nintedanib with food. Avoid taking an herbal supplement containing St. John's wort. TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: The most common side effects of Ofev are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure. Tell them about all prescription, over-the-counter, and other drugs you take. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients. Ofev isnt known to interact with alcohol. What should I tell my doctor before using Ofev? You may have diarrhea while taking Ofev. URL of this page: https://medlineplus.gov/druginfo/meds/a615009.html. Drug class: Multikinase inhibitors. As long as you are tolerating nintedanib, and it is still slowing your condition's progression, you can keep taking it. Dosage for long-term interstitial lung disease with scarring. Your doctor should do certain blood tests before you start taking this medicine. Its used to treat certain types of lung disease in adults where there is inflammation and scarring in the lungs. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. If youre concerned about hair loss with Ofev, talk with your doctor. IPF is a rare, debilitating and fatal lung disease that affects as many as 132,000 Americans. Velagacherla V, Suresh A, Mehta CH, Nayak UY, Nayak Y. You have it in the following way: Day 1 You have docetaxel as a drip into your bloodstream over 1 hour. An official website of the United States government. Ofev is used to treat certain forms of interstitial lung disease where you have fibrosis (scarring) in your lungs. In addition, trials often exclude concomitant emphysema on chest imaging, not an uncommon finding in clinical practice. It can help slow down the scarring in your lungs and worsening lung function. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor. The usual recommended dosage of nintedanib is a 150 mg capsule swallowed whole with liquid, taken twice daily approximately 12 hours apart. However, you should not flush this medication down the toilet. Use of the terms male and female in this article refers to sex assigned at birth. What is Ofev?Ofev is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). The careful selection of trial participants limits applicability of outcomes to patients typically seen in practice. Your doctor will tell you how much of this medicine to take and when to take it. Serious side effects and their symptoms can include: * For more information about this side effect, see Side effect details below. What is the most important information I should know about Ofev (nintedanib)? Ketoconazole is an antifungal drug used to treat, Erythromycin (Eryc, Ery-Tab, Eryped). Boehringer Ingelheim, the manufacturer of Ofev, offers a support program called Open Doors. Tyrosine kinases play an important role in cell growth, differentiation, and metabolism and there is substantial evidence that certain tyrosine kinases, notably platelet-derived growth factor receptor (PDGFR), vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), as well as non-receptor tyrosine kinases, are associated with scar tissue and the progression of pulmonary fibrosis and other interstitial lung diseases. However, if it does, it could cause serious side effects in a breastfed child. nintedanib experience nausea 18 out of 100 patients on placebo experience rash 62 out of 100 patients on nintedanib experience rash A B How do I take nintedanib (brand name Ofev) and what side effects can occur? To read about how Ofev performed in clinical trials, see the drugs prescribing information. Expert Opin Drug Saf. If you have any queries about your deliveries you can contact Polar Speed directly on 0800 7833178. Using an NSAID with nintedanib may cause you to bruise or bleed easily. If your diarrhea doesnt get better in a few days or gets worse, see your doctor right away. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. 17 The effect of nintedanib on slowing FVC decline was consistent across patient subgroups defined by baseline characteristics including sex, race To make sure Ofev is safe for you, tell your doctor if you have ever had: bleeding problems (in you or a family member); if you take a blood thinner such as warfarin (Coumadin, Jantoven). This medication is available to patients through specialty pharmacies. With interstitial lung disease, you have a buildup of scar tissue in the interstitium in your lungs. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease. Int J Mol Sci. Women should not become pregnant while taking nintedanib. How long can you take nintedanib? See "Pregnancy and breastfeeding section on the page below. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Hutchinson J, Fogarty A, Hubbard R, et al. See below for more information about nintedanib and pregnancy. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA However, the efficacy of oral hormonal . To read about the types of lung disease Ofev is used for, see the Ofev uses section below. Nintedanib is also used to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD; also known as scleroderma-associated ILD: a disease in which there is scarring of the lungs that is often fatal). It belongs to a class of drugs called tyrosine kinase inhibitors. Nintedanib may cause serious side effects, including: The most common side effects of nintedanib are: These are not all the possible side effects of nintedanib. Your doctor will talk to you about how many cycles of treatment you can have. Do not crush or chew because the drug has a bitter taste. official website and that any information you provide is encrypted Am J Respir Crit Care Med 1998; 157: 199203. The site is secure. You usually take nintedanib twice a day, morning and evening, 12 hours apart. What side effects can this medication cause? Ofev pregnancy and breastfeeding warnings. Nintedanib should always be taken with or straight after meals. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. If your local pharmacy doesnt have these options, your doctor or pharmacist may be able to direct you to one that does. Keep all appointments with your doctor and the laboratory. Immunosuppressants help stop this from happening. New study results provide evidence that Ofev (nintedanib) slows progression of IPF beyond four years with consistent safety - INPULSIS-ON study indicates safety and efficacy of Ofev. If youre interested in finding an alternative to Ofev, talk with your doctor. The exploratory findings of the open-label extension trial are consistent with results from the Phase III INPULSIS trials and show that continued treatment with Ofev, for up to 68 months, has a manageable safety and tolerability profile, with no new safety signals identified. Nintedanib does not change the exposure to oral contraceptives containing ethinylestradiol and levonorgestrel in patients with SSc-ILD. You should take Ofev twice per day. Oncogenesis. Its important to have prompt diarrhea management if you have this side effect. You should stop smoking prior to taking Ofev and avoid smoking during treatment. Do not take more than 300 mg of nintedanib in 1 day. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Both Ofev and Esbriet slow IPFs worsening but do not stop its progression, and neither medication is recommended over the other. In clinical trials, diarrhea was the most common side effect reported with Ofev. Ofev is also used to treat chronic (long lasting) interstitial lung disease in which the scar tissue keeps getting worse. Nintedanib can cause birth defects or death to an unborn baby. Ofev helps to slow down the formation of scar tissue in your lungs. Both Ofev and Esbriet slow IPFs worsening but do not stop its progression, and neither medication is recommended over the other. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Comments: You are encouraged to report negative side effects of prescription drugs to the FDA. Non-receptor tyrosine kinases: Lck, Lyn, and Src kinases. If recommended by your doctor, you may be able to receive a 90-day supply of Ofev, so theres less concern about running out of the medication. 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. Multi-Targeting Approach in Selection of Potential Molecule for COVID-19 Treatment. Pirfenidone and nintedanib are approved for treatment of idiopathic pulmonary fibrosis (IPF), but questions remain regarding indications and timing of initiation, side effects, and long-term outcomes. For more information, ask your doctor or pharmacist. Previously, IPF has been managed using immunosuppressive therapy; however, it has been shown that this is associated with increased mortality. In addition to the use listed above, Ofev may be used for other purposes. Ofev comes. There has been one phase 4 trial that has investigated the combination of Ofev (nintedanib) and Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF) that showed a slightly increased risk of side effects with combination treatment, but the trial was not large enough to make a solid conclusion about increased/decreased effectiveness. Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking Ofev. Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF; scarring of the lungs with an unknown cause). Federal government websites often end in .gov or .mil. Call 911 or your local emergency number if your symptoms feel life threatening or if you think youre having a medical emergency. To treat interstitial lung disease * with scarring, the usual dosage of Ofev is 150 mg two times per day. As a result, your organs and other body tissues may not get enough oxygen. tell your doctor if you or anyone in your family has ever had a bleeding problem, if you have or have ever had liver or heart disease, diverticular disease (diverticulitis; small pouches in the lining of the large intestine that can become inflamed), or blood clots, and if you have had recent abdominal surgery. Our employees create and engage in programs that strengthen our communities. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. 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. Below are expert answers to some common questions from patients about living with PF. Nintedanib can cause birth defects or death to an unborn baby. (A class of drugs is a group of medications that work in a similar way.). As long as you are tolerating nintedanib, and it is still slowing your condition's progression, you can keep taking it. Ofev is not approved for use by anyone younger than 18 years old. The scar tissue may be produced because of inflammation (swelling) or damage to the interstitium. Ask for help and accept help when offered. If you have any of these problems, talk with your doctor about which highly effective birth control method is right for you. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. Call 911 or your local emergency number if your symptoms feel life threatening or if you think youre having a medical emergency. This article provides several useful tips on medication disposal. from 8 AM - 9 PM ET. The drug hasnt been studied during pregnancy. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. A generic drug is an exact copy of the active drug in a brand-name medication. You could also download a reminder app on your phone. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Copyright 1996-2023 Cerner Multum, Inc. If you have a question that is not answered, call our free Lung HelpLine at 1-800-LUNGUSA (1-800-586-4872). For more information about this side effect, see Side effect details below. Unable to load your collection due to an error, Unable to load your delegates due to an error. * This is a partial list of mild side effects from Ofev. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American. We comply with the HONcode standard for trustworthy health information. Swallow the capsules whole with a liquid. Real-world experiences also support the findings of previously conducted clinical trials and show that nintedanib is effective for the management of IPF and is associated with reducing disease progression. These solutions help replace lost fluids and electrolytes. If you have any questions about eating certain foods with Ofev, talk with your doctor. Ofev is usually taken 2 times per day, every 12 hours. The expiration date helps guarantee that the medication is effective during this time. However, if you have digestive side effects such as diarrhea, nausea, or vomiting with Ofev, it may help to avoid certain foods. The doses should be taken 12 hours apart. Some supplements may help with the symptoms of lung disease. If you miss a dose of nintedanib, skip the missed dose and continue your regular schedule. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). It can cause symptoms such as: You may also have other symptoms, depending on the specific type of interstitial lung disease you have. -, Demedts M, Behr J, Buhl R, et al. Ofev, on the other hand, helps to slow down the formation of scar tissue in your lungs. PMC Take nintedanib capsules at around the same times every day. Specifically, Ofev is FDA-approved to treat: Ofev contains the active drug nintedanib. It is also used to treat certain types of chronic fibrosing interstitial lung diseases (ILD; an ongoing disease in which there is increased scarring of the lungs). The annual rate of decline in FVC was consistent irrespective of age, race and FVC % predicted at the start of INPULSIS-ON. This is not a complete list of side effects and others may occur. Early diagnosis and proper care are critical to helping people treat their condition. Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is used for a purpose other than what its approved for. If you miss a dose of this medicine, take your next dose at your regular time. In this review, we will discuss the clinical trial evidence and real-world experience for nintedanib in the management of IPF. Swallow the capsule whole and do not crush, chew, break, or open it. Brassicas, such as broccoli, cauliflower, brussels sprouts, cabbage, collards, or Bok choy, Fried or greasy foods, such as French fries, burgers, and fried chicken, High-fiber foods, such as beans, lentils, or whole grains. HOW TO TAKE OFEV OFEV is taken twice a day, about 12 hours apart, with food. Liver problems may be more likely in women, in people who weigh less than 143 pounds (65 kilograms), and in people of Asian descent. The interstitium is a network of tissue that runs throughout your lungs and supports the alveoli (tiny air sacs). Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. -, Raghu G, Collard HR, Egan JJ, et al. Ofev can cause severe diarrhea, which can be life-threatening if it leads to dehydration. 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. These lung conditions can also cause a cough and breathing difficulties, which can stop you getting enough sleep. An acute exacerbation is a sudden deterioration in respiratory function, in many cases with unknown cause, which negatively impacts the disease course and often leads to death within a few months. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. If you have diarrhea while taking Ofev, see your doctor right away. Indeed, pirfenidone has been available for a number of years outside the U.S. for IPF treatment, yet few long-term follow-up studies exist and are limited to center-specific reviews of clinical experience. No, there arent any foods that you should specifically avoid while taking Ofev. Your doctor will likely recommend taking an antidiarrheal medication such as loperamide (Imodium) to help stop your diarrhea. . If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Systemic sclerosis is a condition where your body produces too much of a connective tissue called collagen. Your doctor will determine the best dosage to fit your needs. Generics usually cost less than brand-name drugs. Take your doses at regular intervals, usually every 12 hours. Idiopathic means the condition has no known cause. It causes progressive scarring of the lungs, resulting in continuous and irreversible deterioration in lung function and breathing difficulties. It blocks certain signals and pathways that are involved in the formation of scar tissue. If you no longer need to take Ofev and have leftover medication, its important to dispose of it safely. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine. Symptoms of a severe allergic reaction can include: Call your doctor right away if you have an allergic reaction to Ofev, as the reaction could become severe. You may report side effects to FDA at 1-800-FDA-1088. Visit www.fda.gov/safety/medwatchor call 1-800-FDA-1088. pain in the upper right part of the stomach, numbness or weakness on one side of your body, pain or swelling in your stomach area, nausea, vomiting, fever, chills, or blood in your stool. You take dabrafenib twice a day, morning and evening, about 12 hours apart. Of the 734 patients treated in INPULSIS-ON, 430 had received Ofev in INPULSIS and continued Ofev in INPULSIS-ON, while 304 had received placebo in INPULSIS and initiated Ofev in INPULSIS-ON. There arent any other herbs or supplements that have been specifically reported to interact with Ofev. But if they become more severe or dont go away, talk with your doctor or pharmacist. If you need financial support to pay for Ofev, or if you need help understanding your insurance coverage, help is available. Nintedanib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Some people may also have acute flare-ups, where symptoms suddenly and unexpectedly get worse. Other drugs are available that can treat your condition. As IPF progresses, lung function gradually and irreversibly deteriorates.
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