Resources This causes your lung function to decline and your symptoms to worsen as the condition progresses. In the last 5 years, two disease-modifying agents have been licensed for use in IPF, namely pirfenidone and nintedanib. PDF 12-dose Isoniazid (INH) plus Rifapentine Regimen for Latent TB Results also indicate that the long-term efficacy of Ofev in reducing disease progression may be sustained in patients who require dose adjustments. These are not all the possible side effects of Ofev. Nintedanib should always be taken with or straight after meals. For more information, ask your doctor or pharmacist. Read the Patient Information Leaflet if available from your pharmacist before you start taking nintedanib and each time you get a refill. Nintedanib: A Review in Fibrotic Interstitial Lung Diseases. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib. There arent any foods that have been specifically reported to interact with Ofev. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. tell your doctor if you use tobacco products. It should not be chewed, crushed, or opened. The mechanical phenotypic plasticity of melanoma cell: an emerging driver of therapy cross-resistance. Do not take a double dose to make up for a missed one. You take nintedanib with docetaxel as part of a 21 day cycle of treatment . This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. Your doctor may need to decrease your dose or stop treatment if you experience certain severe side effects. Sugar-free candy made with alcohols such as xylitol. Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink, Ofev What special dietary instructions should I follow? Your doctor should do certain blood tests before you start taking this medicine. 2015;8(Spec Feature):101-104. Nintedanib comes as a capsule to take by mouth. Ask your pharmacist any questions you have about refilling your prescription. You should not breastfeed while using this medicine. For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS. As a result, your organs and other body tissues may not get enough oxygen. How do I get rifapentine? Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. PMC This list does not contain all drugs that may interact with Ofev. It can help slow down the scarring in your lungs and worsening of your lung function. . tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. If you have any queries about your deliveries you can contact Polar Speed directly on 0800 7833178. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Ofev pregnancy and breastfeeding warnings. These include: Note: For more information about the potential negative effects of Ofev, see the Ofev side effects section above. 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. Usual Adult Dose for Idiopathic Pulmonary Fibrosis: 150 mg orally every 12 hours All rights reserved. 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. This medicine is a capsule that is usually taken twice a day with food. But if they become more severe or dont go away, talk with your doctor or pharmacist. The site is secure. 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). Talk with your doctor about what birth control method is right for you during this time. If youre sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while taking Ofev. It is not known if Ofev passes into your breast milk. As long as you are tolerating nintedanib, and it is still slowing your condition's progression, you can keep taking it. However, you should not flush this medication down the toilet. -. FOIA Nintedanib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Ofev is an effective treatment for chronic interstitial lung disease with worsening fibrosis. Disclaimer. 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? severe ongoing nausea, vomiting, or diarrhea; severe stomach pain, bloating, or tenderness; bleeding from your rectum or blood in your stools; easy bruising or bleeding, any wound that will not heal; fever, chills, cough with mucus, chest pain, feeling short of breath; heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; liver problems - stomach pain (upper right side), loss of appetite, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or. Bethesda, MD 20894, Web Policies Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Rifapentine can be ordered from your distributor or wholesaler, or directly from the manufacturer, Sanofi-Aventis, at www.sanofi.us and can be found in the "other products" link. Usual Adult Dose for Chronic Lung Disease: Skip the missed dose and use your next dose at the regular time. This technology appraisal is for treating idiopathic pulmonary fibrosis in people with a forced vital capacity (FVC) between 50% and 80% predicted. Long-term therapy appeared to support relative maintenance of function up to 63 months with an acceptable safety profile. Do not let anyone else take your medication. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Take nintedanib exactly as your doctor tells you to take it. These include: The following information describes dosing thats commonly used or recommended. 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. Store this medicine in the original container at room temperature, away from moisture and heat. Both types of drugs may be used to treat certain lung conditions that involve inflammation and scarring in your lungs. 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 dose may be decreased or treatment paused if you have side effects or changes in your liver tests. Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Ofev is a brand-name prescription medication. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. 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. Ofev is meant to be a long-term treatment. This can include setting an alarm or using a timer. Use of the terms male and female in this article refers to sex assigned at birth. Nintedanib induces senolytic effect via STAT3 inhibition. If your prescription label is hard to read, talk with your doctor or pharmacist. Increased risk of bleeding. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Generic name: nintedanib It helps prevent changes to the lung tissue. It is used for types of ILD that cause scarring in the lungs such as idiopathic pulmonary fibrosis (IPF), certain chronic fibrosing interstitial lung diseases (ILDs) and nintedanib helps lung function in people with systemic sclerosis-associated interstitial lung disease. Before approving coverage for Ofev, your insurance company may require you to get prior authorization. Because they work on different aspects of the fibrotic cascade, there has been some suggestion that there may be some benefit in combining them. Available for Android and iOS devices. What should I tell my doctor before using Ofev? You should stop smoking prior to taking Ofev and avoid smoking during treatment. Last updated on Sep 20, 2022. Full article: Obstacles to early treatment of idiopathic pulmonary Global incidence and mortality of idiopathic pulmonary fibrosis: a systematic review. About the Disease Disease Progression Nintedanib is used to treat idiopathic pulmonary fibrosis. About Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Tell your doctor if you become pregnant. 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. Ofev isnt known to interact with alcohol. Ofev may be available through a mail-order pharmacy. Indeed, pirfenidone has been available for a number of years outside the U.S. for IPF treatment, yet few long-term follow-up . With idiopathic pulmonary fibrosis, scar tissue builds up in the interstitium in your lungs. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Clinical trials to date have excluded people with FVC of less than 50 percent predicted, leaving little understanding of how treatment affects people with more-advanced disease. -To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Most of these side effects may go away within a few days or a couple of weeks. A generic drug is an exact copy of the active drug in a brand-name medication. It is not known if nintedanib passes into your breast milk. Viruses. Nintedanib is in a class of medications called kinase inhibitors. Nintedanib can be taken long-term, and research has shown it is safe for up to 51 months, possibly longer. Fill Material: triglycerides, hard fat, lecithin. -, Raghu G, Collard HR, Egan JJ, et al. If youre interested in this option, check with your doctor, pharmacist, or insurance company. In clinical trials, diarrhea was the most common side effect reported with Ofev. The usual dose of OFEV is 1 pill, twice a day with food. 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. Continue reading. New study results provide evidence that Ofev (nintedanib) slows Immunosuppressants help stop this from happening. 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. Tell them about all prescription, over-the-counter, and other drugs you take. Store nintedanib at room temperature between 68F to 77F (20C to 25C). What should I know about storage and disposal of this medication? Nintedanib is used to treat idiopathic pulmonary fibrosis (IPF; scarring of the lungs with an unknown cause). Women who are able to become pregnant should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after treatment. Ofev contains the active drug nintedanib. Or it may have no known cause. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. sharing sensitive information, make sure youre on a federal If you and your doctor determine that Ofev is safe and effective for you, youll likely take it long term. How long does it take for Ofev to start working? Your doctor will order certain lab tests before and during your treatment to check your body's response to nintedanib. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib. Its used to treat certain types of lung disease in adults where there is inflammation and scarring in the lungs. You take dabrafenib twice a day, morning and evening, about 12 hours apart. The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. You may report side effects to FDA at 1-800-FDA-1088. 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. However, based on the way it works and results from animal studies, this drug is likely to harm a fetus if used during pregnancy. Ofev, on the other hand, helps to slow down the formation of scar tissue in your lungs. Some may be a better fit for you than others. If you would like to notify the FDA about a side effect youve had with Ofev, you can do so through MedWatch. Nintedanib is also recommended for people with an FVC above 80% predicted ( NICE technology . Interstitial lung disease associated with systemic sclerosis makes breathing difficult. Cho HJ, Hwang JA, Yang EJ, Kim EC, Kim JR, Kim SY, Kim YZ, Park SC, Lee YS. Exploratory efficacy endpoints included the annual rate of decline in FVC calculated over 192 weeks, absolute change in FVC (mL) from baseline to week 192, time to first acute exacerbation and time to death. If you are pregnant or planning a pregnancy: If you are breastfeeding or are planning to breastfeed: Ofev Inactive ingredients: FACT 5: Doctors and Patients Around the World Are Choosing OFEV Call your doctor right away if you have serious side effects. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. It's normally taken as capsules 3 times a day. Interstitial lung disease makes breathing difficult and causes shortness of breath and fatigue. Where patients had little opportunity to fight disease in the past, current therapies offer a chance to slow disease progression and delay severity of symptoms. Barrier forms include a condom, diaphragm, cervical cap, or contraceptive sponge). Nintedanib: MedlinePlus Drug Information It can also help prevent acute flare-ups. This tells your doctor the effect your lung disease has on your ability to inhale and exhale, and this measurement, alongside others such as worsening symptoms or worsening imaging, determine how effective nintedanib is for you at slowing disease progression. tell your doctor if you are breastfeeding. You are encouraged to report negative side effects of prescription drugs to the FDA. Uses: MeSH For more information about taking Ofev during pregnancy, see the Ofev and pregnancy section above. Ofev is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). Bronchiectasis is a lung condition that causes persistent cough and excess phlegm. If you or your caregiver accidently comes in contact with the content of the capsule, wash hands well right away. As long as you are tolerating nintedanib, and it is still slowing your condition's progression, you can keep taking it. Do not chew, crush, or open capsules. Nintedanib can cause birth defects or death in an unborn a baby. New Data Shows OFEV (nintedanib) Efficacy is Sustained Long-term with No New Safety Signals in Patients with IPF Ridgefield, Conn., Tuesday, 09/29/2015 - 14:00 Interim analysis of INPULSIS-ON, an open-label extension study, shows beneficial effect of OFEV on slowing disease progression was maintained and the change from baseline in FVC was . Its important to have prompt diarrhea management if you have this side effect. Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update. It is usually taken with food every 12 hours (twice a day). This content does not have an English version. FAQ: Nintedanib | Patient Education | UCSF Health All Rights Reserved. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Idiopathic pulmonary fibrosis is a condition where scar tissue builds up in your lungs. You usually take nintedanib twice a day, morning and evening, 12 hours apart. It belongs to a class of drugs called tyrosine kinase inhibitors. Ofev may affect fertility (your ability to have children) in women. Diarrhea is usually mild or moderate, but in some cases, it can be severe. Your next few doses may be delayed based on the results. For more information about the possible side effects of Ofev, talk with your doctor or pharmacist. This could increase your risk for side effects from Ofev. Hutchinson J, Fogarty A, Hubbard R, et al. This article provides several useful tips on medication disposal. Nintedanib can be taken long-term, and research has shown it is safe for up to 51 months, possibly longer. As with most drugs, some people can have an allergic reaction after taking Ofev. As IPF progresses, lung function gradually and irreversibly deteriorates. tell your doctor if you are pregnant, plan to become pregnant, or can possibly become pregnant. Brand name: Ofev 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. Ofev is not approved for use by anyone younger than 18 years old. Idiopathic pulmonary fibrosis (IPF) is a fibrotic interstitial lung disease associated with significant morbidity and mortality. tell your doctor what herbal products you are taking, especially St. John's wort. This causes your symptoms and lung function to worsen as the condition progresses. The INPULSIS-ON trial featured a large cohort of patients with IPF who received Ofev, and these data add to the growing body of evidence suggesting that Ofev provides long-term benefits to patients with IPF. What is the Nintedanib market growth? -, Ley B, Collard HR, King TE., Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Using this service may help lower the drugs cost and allow you to get your medication without leaving home. Dosage form: capsule have a bleeding problem or a family history of a bleeding problem. Maximum dose: 300 mg/day This site needs JavaScript to work properly. It causes progressive scarring of the lungs, resulting in continuous and irreversible deterioration in lung function and breathing difficulties. Previously, IPF has been managed using immunosuppressive therapy; however, it has been shown that this is associated with increased mortality. Velagacherla V, Suresh A, Mehta CH, Nayak UY, Nayak Y. Ofev is a type of drug called a tyrosine kinase inhibitor. About idiopathic pulmonary fibrosis (IPF)IPF is a rare and serious lung disease that causes permanent scarring of the lungs. To learn about other mild side effects, talk with your doctor or pharmacist, or view Ofevs prescribing information. Would you like email updates of new search results? This medication is available to patients through specialty pharmacies. Lysosomes as a Target of Anticancer Therapy. Overview | Nintedanib for treating idiopathic pulmonary fibrosis The .gov means its official. Clipboard, Search History, and several other advanced features are temporarily unavailable. 2023 Jan 22;24(3):2176. doi: 10.3390/ijms24032176. 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. Call your doctor for medical advice about side effects. 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. Take nintedanib exactly as directed. Information is also available online at https://www.poisonhelp.org/help. Expert Opin Drug Saf. R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales. 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. Do not take more than 300 milligrams of nintedanib in one day. All these studies were randomized, double-blind, placebo-controlled trials comparing Ofev 150 mg twice daily to placebo for 52 weeks. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it. Before taking Ofev, talk with your doctor and pharmacist. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. 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. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen. Call 911 or your local emergency number if your symptoms feel life threatening or if you think youre having a medical emergency. The annual rate of decline in FVC was consistent irrespective of age, race and FVC % predicted at the start of INPULSIS-ON. Below is information on other approved uses for Ofev. High-dose acetylcysteine in idiopathic pulmonary fibrosis. Can diet help improve depression symptoms? are breastfeeding or plan to breastfeed. AHFS Patient Medication Information. Ofev is an effective treatment for idiopathic pulmonary fibrosis. You will need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. You may need to take medication to prevent or quickly treat diarrhea. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives. You may need to take medication to prevent or quickly treat diarrhea. 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. Before Rifampin is an antibacterial drug mainly used to treat. For some drugs, doing so may lead to unwanted side effects or overdose. Dosage Information | OFEV (nintedanib) Copyright 1996-2023 Cerner Multum, Inc. What is the mechanism of action of nintedanib? If you have fatigue, talk with your doctor about ways to manage it. 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. The recommended dose age is 150 mg (one pill) twice daily with food. For advanced melanoma you take dabrafenib and trametinib for as long as they are working or until the side effects get too bad. Try to improve your sleep, for example, using extra pillows to raise you may help ease breathlessness. Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a healthcare professional. Ofev is FDA-approved to treat idiopathic pulmonary fibrosis in adults. Unauthorized use of these marks is strictly prohibited. If you have trouble swallowing Ofev, talk with your doctor or pharmacist. If you no longer need to take Ofev and have leftover medication, its important to dispose of it safely. Ofev can cause birth defects or death in an unborn baby. It's recommended if breathing tests have shown your lung capacity is 50% to 80% of what would normally be expected. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. Do not take more or less of it or take it more often than prescribed by your doctor. Its available in two strengths: 100 milligrams (mg) and 150 mg. For information about the effectiveness of Ofev, see the Ofev uses section below. All rights reserved. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. You may have fatigue while taking Ofev. Version: 4.01. No, Ofev capsules should not be crushed, split, opened, or chewed. Blocking these enzymes helps decrease fibrous tissue forming in the lungs and so stops the symptoms of lung disease getting worse. nintedanib Uses, Side Effects, Dosage & Interactions 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). See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. Nintedanib (Oral Route) Description and Brand Names - Mayo Clinic Learn more about the causes, symptoms, and treatment options. Ofev (nintedanib): Uses, Side Effects & Dosage - GoodRx FVC (forced vital capacity) is a lung function test that measures the total amount of air exhaled during the forced expiratory volume (FEV) test.