In the last 5 years, two disease-modifying agents have been licensed for use in IPF, namely pirfenidone and nintedanib. The drugs mirrored each other in the number of phase III clinical trials leading to approval and slowing of forced vital capacity (FVC) decline, with pirfenidone touting a signal for improved mortality, and nintedanib suggesting decreased incidence of acute exacerbation in two of its three large trials. Idiopathic pulmonary fibrosis makes breathing difficult. Ofev contains the active drug nintedanib. If youre breastfeeding, talk with your doctor about other healthy ways to feed your child while youre taking Ofev. 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. Ofev pregnancy and breastfeeding warnings. Talk with your doctor about the method of birth control thats right for you. Everything you need to know about mesothelioma: Esbriet, Actemra, tocilizumab, pirfenidone, nintedanib, Actimmune, interferon gamma-1b. NINTEDANIB IS A MULTI-TARGETED TYROSINE KINASE INHIBITOR THAT WORKS BY INHIBITING PATHWAYS INVOLVED IN THE PATHOGENESIS OF ILDs 1-3. . What should I know about storage and disposal of this medication? All rights reserved. 2021 Apr;81(5):575-586. doi: 10.1007/s40265-021-01487-0. Visit www.fda.gov/safety/medwatchor call 1-800-FDA-1088. Nintedanib inhibits the following RTKs: Research has shown that nintedanib starts to improve FVC within 6 weeks of starting the medication. Ofev is not available in a generic form. Women should not become pregnant while taking nintedanib. Panlobular emphysema affects the entire lung and causes coughing, wheezing, and breathing difficulties. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. Take your doses at regular intervals, usually every 12 hours. Ofev can cause birth defects or death in an unborn baby. 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? With idiopathic pulmonary fibrosis, scar tissue builds up in the interstitium in your lungs. Ketoconazole is an antifungal drug used to treat, Erythromycin (Eryc, Ery-Tab, Eryped). Get emergency medical help if you have signs of an allergic reaction to Ofev: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor for medical advice about side effects. Living with Pulmonary Fibrosis FAQ | American Lung Association Ofev is recommended as a treatment option for idiopathic pulmonary fibrosis in guidelines from the American Thoracic Society. * This is a partial list of mild side effects from Ofev. No, Ofev doesnt reverse existing scarring in your lungs. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Store this medicine in the original container at room temperature, away from moisture and heat. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. URL of this page: https://medlineplus.gov/druginfo/meds/a615009.html. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. See Important information section above. Interstitial lung disease makes breathing difficult. Immunosuppressants help stop this from happening. Indeed, pirfenidone has been available for a number of years outside the U.S. for IPF treatment, yet few long-term follow-up . Dosage form: capsule What food should I avoid while taking Ofev? The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. Also tell them about any vitamins, herbs, and supplements you use. Nintedanib: A Review of Its Use in Patients with Idiopathic Pulmonary Fibrosis. 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. Your doctor will determine the best dosage to fit your needs. Ofev is available only as a brand-name medication. Serious side effects and their symptoms can include: * For more information about this side effect, see Side effect details below. The insurance company will review the prior authorization request and decide if the drug will be covered. PDF Nintedanib - patient information - UHS Your doctor should do certain blood tests before you start taking this medicine. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This completes 1 cycle of treatment. Ofev is meant to be a long-term treatment. Duplication for commercial use must be authorized by ASHP. You are encouraged to report negative side effects of prescription drugs to the FDA. Ofev Dosage: Form, Strengths, How to Take, and More - Healthline Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. The scarring in your lungs tends to get worse over time. These solutions help replace lost fluids and electrolytes. However, Ofev commonly causes digestive side effects such as diarrhea, nausea, and vomiting. If youre pregnant or plan to become pregnant, talk with your doctor about alternative treatment options for your lung condition. Tell your doctor if you become pregnant. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. It is usually taken with food every 12 hours (twice a day). One in the morning and 1 in the evening, about 12 hours apart. It should not be chewed, crushed, or opened. Sugar-free candy made with alcohols such as xylitol. Idiopathic pulmonary fibrosis is a condition where scar tissue builds up in your lungs. Am J Respir Crit Care Med 1998; 157: 199203. It belongs to a class of drugs called tyrosine kinase inhibitors. Generics tend to cost less than brand-name drugs. The primary objective of the INPULSIS-ON trial was to characterize the long-term safety and tolerability of Ofev in patients with IPF, assessed via clinical and laboratory evaluation and the recording of adverse events. It can lead to fatal complications. Finally, for some patients, disease stability (defined by a relative lack of symptoms or minimally changed FVC) may be justification for deferring initiation of drug therapy, though the expectation of future progression must be acknowledged. Do not crush or chew because the drug has a bitter taste. It is also important information to carry with you in case of emergencies. Below is information on other approved uses for Ofev. Brand name: Ofev Other drugs may interact with nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Both types of drugs may be used to treat certain lung conditions that involve inflammation and scarring in your lungs. Nintedanib induces senolytic effect via STAT3 inhibition. Swallow the capsule whole and do not crush, chew, break, or open it. We comply with the HONcode standard for trustworthy health information. Examples of these side effects include: Also, Ofev can sometimes cause liver problems. Furthermore, patient variables that predict a medication response are yet to be determined. Wash your hands well right away if your skin comes in contact with the content inside the capsules. Your doctor may occasionally change your dose. -To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Serious Side Effects TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including: + Open All Liver Problems Diarrhea Nausea and Vomiting Heart Attack Stroke Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. They can tell you about other medications that may work well for you. It is not known if nintedanib passes into your breast milk. It can cause symptoms such as: The scarring in your lungs typically gets worse over time, causing your symptoms and lung function to worsen as the condition progresses. Ofev is not safe to take during pregnancy. If youre concerned about hair loss with Ofev, talk with your doctor. Nintedanib can be taken long-term, and research has shown it is safe for up to 51 months, possibly longer. But if they become more severe or dont go away, talk with your doctor or pharmacist. These include: The following information describes dosing thats commonly used or recommended. Nintedanib can cause birth defects or death to an unborn baby. Ofev is an effective treatment for slowing lung function decline in people with interstitial lung disease associated with systemic sclerosis. IPF causes scar tissue to form deep within your lungs. Foods to avoid if you have digestive side effects include: If you have nausea, vomiting, or diarrhea with Ofev, its best to stick to bland foods that are easy on your stomach. Nintedanib is a tyrosine kinase inhibitor with antifibrotic properties that has also been shown to significantly reduce the progression of the disease. It is a good idea to have at least 2 weeks . To read about the types of lung disease Ofev is used for, see the Ofev uses section below. What is the most important information I should know about Ofev (nintedanib)? It works by blocking the action of enzymes involved in causing fibrosis. Ofev can cause mild or serious side effects. How long can you take nintedanib? Ofev is an effective treatment for idiopathic pulmonary fibrosis. The capsules should be swallowed whole with a drink. Nintedanib can cause birth defects or death in an unborn a baby. Call your doctor if you have any unusual problems while taking this medication. Ofev is FDA-approved to slow lung function decline in adults with interstitial lung disease associated with systemic sclerosis. N Engl J Med 2005; 353: 22292242. 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. Idiopathic pulmonary fibrosis (IPF) is a fibrotic interstitial lung disease associated with significant morbidity and mortality. Clipboard, Search History, and several other advanced features are temporarily unavailable. Licensed from: Boehringer Ingelheim International GmbH. Nintedanib comes as a capsule to take by mouth. The expiration date helps guarantee that the medication is effective during this time. MeSH They will usually contact you within 2 weeks of your appointment at Southmead hospital to arrange dates for delivery. The .gov means its official. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. Bronchiectasis is a lung condition that causes persistent cough and excess phlegm. If you think youve taken too much of this drug, call your doctor. Would you like email updates of new search results? If you have any questions, ask your doctor or pharmacist.. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. This causes your lung function to decline and your symptoms to worsen as the condition progresses. You should not breastfeed while taking Ofev. Additional information can be found at www.ofev.com . If you have a sexual partner whos able to become pregnant, talk with your doctor about your birth control needs while taking Ofev. Continue reading, Experts are not sure exactly why Ofev causes diarrhea but research has suggested that it may be due to receptor inhibition (Ofev is a triple receptor [PDGFR, VEGFR, or FGFR] tyrosine kinase inhibitor) or via a direct inflammatory action on intestinal mucosa by Ofev or its breakdown products. Do not take two doses at once to make up for a missed dose. Its not known if Ofev passes into breast milk. Systemic sclerosis that affects your lungs is a form of interstitial lung disease. Immunosuppressants are drugs that weaken your immune system. Call your doctor right away if you have serious side effects. Nintedanib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Nintedanib is a tyrosine kinase inhibitor (TKI), which blocks enzymes in cells in the lungs called tyrosine kinases. Because they work on different aspects of the fibrotic cascade, there has been some suggestion that there may be some benefit in combining them. Increased risk of bleeding. Some Medicare plans may help cover the cost of mail-order medications. Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. You can also ask your pharmacist for information about how to dispose of your medication. Generic name: nintedanib Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. 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. Barrier forms include a condom, diaphragm, cervical cap, or contraceptive sponge). Instead, its an anti-fibrosis (or anti-scarring) drug. Use this . Ofev: Uses, Dosage & Side Effects - Drugs.com Rifampin is an antibacterial drug mainly used to treat. It can help slow down the scarring in your lungs and worsening lung function. For example, in clinical practice, up to 50 percent of patients with IPF may have "possible" usual interstitial pneumonia pattern on chest CT scans, while patients in clinical trials, subjected to diagnostic adjudication by committee, represent a purer diagnostic group. You may need to have a negative pregnancy test before starting this treatment. Cho HJ, Hwang JA, Yang EJ, Kim EC, Kim JR, Kim SY, Kim YZ, Park SC, Lee YS. Nintedanib can cause birth defects or death to an unborn baby. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. Idiopathic pulmonary fibrosis is one form of interstitial lung disease that has no known cause. Recent real-word studies also suggest that nintedanib stabilizes lung function till lung transplantation, with no increased surgical complications or postoperative mortality after lung transplantation. FAQ: Nintedanib | Patient Education | UCSF Health Ofev comes as a capsule that you take by mouth. An official website of the United States government. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. Is the ketogenic diet right for autoimmune conditions? Swallow the capsules whole with liquid; do not chew or crush them. 2023 Jan 12;15(1):213. doi: 10.3390/v15010213. Ofev: Side effects, cost, how it works, and more - Medical News Today As IPF progresses, lung function gradually and irreversibly deteriorates. Hutchinson J, Fogarty A, Hubbard R, et al. However, if it does, it could cause serious side effects in a breastfed child. -, Ley B, Collard HR, King TE., Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. If you become pregnant while taking nintedanib, call your doctor immediately. Specifically, Ofev is FDA-approved to treat: Ofev contains the active drug nintedanib. Ofev can cause harm, birth defects or death to an unborn baby. Am J Respir Crit Care Med 2011; 183: 431440. You. While multiple trials assessing different mechanisms and approaches to treatment have proved negative over the past decade and a half, two drug therapies have recently become available for the directed treatment of idiopathic pulmonary fibrosis (IPF). Nintedanib Oral: Uses, Side Effects, Interactions, Pictures - WebMD The interstitium is a network of tissue that runs throughout your lungs and supports the alveoli (tiny air sacs). However, if you have digestive side effects such as diarrhea, nausea, or vomiting with Ofev, it may help to avoid certain foods. No, there arent any foods that you should specifically avoid while taking Ofev. If youre interested in this option, check with your doctor, pharmacist, or insurance company. Unauthorized use of these marks is strictly prohibited. official website and that any information you provide is encrypted Ofev may affect fertility (your ability to have children) in women. government site. With interstitial lung disease associated with systemic sclerosis, the fibrosis in your lungs tends to get worse over time. Lysosomes as a Target of Anticancer Therapy. Tell your doctor about all your current medicines and any medicine you start or stop using. For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. 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). You may have diarrhea while taking Ofev. Pirfenidone Uses, Side Effects & Warnings - Drugs.com * Sex and gender exist on spectrums. Using an NSAID with nintedanib may cause you to bruise or bleed easily. Ofev is also used to slow the decline in lung function in people with a disorder called systemic sclerosis-associated interstitial lung disease (sometimes called scleroderma-associated ILD). 8600 Rockville Pike They also may be able to recommend tools that can make it simpler to open lids. to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF). What is the Nintedanib market growth? The drug hasnt been studied during pregnancy. About idiopathic pulmonary fibrosis (IPF)IPF is a rare and serious lung disease that causes permanent scarring of the lungs. Non-receptor tyrosine kinases: Lck, Lyn, and Src kinases. Information is also available online at https://www.poisonhelp.org/help. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. If you take too much of this medicine, call your doctor or go to the nearest hospital emergency room right away. Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update. When pooling data for two of the pirfenidone trials, 21 percent of participants still had FVC decline greater than 10 percent while on therapy. See "Pregnancy and breastfeeding section on the page below. 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. Ofevs manufacturer recommends that females* who can become pregnant should use birth control while taking Ofev and for at least 3 months after your last dose of Ofev. If you would like to notify the FDA about a side effect youve had with Ofev, you can do so through MedWatch. Ofev can cause severe diarrhea, which can be life-threatening if it leads to dehydration. If you have trouble opening medication bottles, ask your pharmacist if they can put Ofev in an easy-open container. This content does not have an Arabic version. "We are encouraged by these results showing that Ofev slows disease progression of IPF beyond four years," said Mitchell Kaye, M.D., president of Minnesota Lung Center/Minnesota Sleep Institute, Minneapolis. Take nintedanib exactly as directed. Swallow the capsule whole and do not crush, chew, break, or open it. Nintedanib is also recommended for people with an FVC above 80% predicted ( NICE technology . In case of overdose, call the poison control helpline at 1-800-222-1222. Blocking these enzymes helps decrease fibrous tissue forming in the lungs and so stops the symptoms of lung disease getting worse. Take your doses at regular intervals, usually every 12 hours. a bleeding problem or a family history of a bleeding problem, had recent surgery in your stomach (abdominal) area, are breastfeeding or plan to breastfeed. Varone F, Sgalla G, Iovene B, Bruni T, Richeldi L. Expert Opin Pharmacother. Symptoms of a mild allergic reaction can include: A more severe allergic reaction is rare but possible. Evidence-based recommendations on nintedanib (Ofev) for adults with idiopathic pulmonary fibrosis. It causes progressive scarring of the lungs, resulting in continuous and irreversible deterioration in lung function and breathing difficulties. Instead, the best way to dispose of your medication is through a medicine take-back program. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. The American Thoracic Society recommends Ofev as a treatment option for this condition. The symptoms you have will depend on what parts of your body are affected. Other drugs may affect nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Do not take the missed dose. IPF Patients Live Longer on Ofev Compared with Placebo, Analysis Take OFEV exactly as your doctor tells you to take it Your doctor will tell you how much OFEV to take and when to take it Medically reviewed by Melisa Puckey, BPharm. No, Ofev capsules should not be crushed, split, opened, or chewed. It blocks certain signals and pathways that are involved in the formation of scar tissue. If you miss a dose of this medicine, take your next dose at your regular time. It can help slow down the worsening of your lung condition, but it cant cure it. This technology appraisal is for treating idiopathic pulmonary fibrosis in people with a forced vital capacity (FVC) between 50% and 80% predicted. 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.