It helps prevent changes to the lung tissue. Ofev is used in people with diseases that cause scar tissue (fibrosis) to form deep within the lungs. Ofev pregnancy and breastfeeding warnings. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. Keywords: -. 2023 Feb 11;12(1):7. doi: 10.1038/s41389-023-00452-8. The insurance company will review the prior authorization request and decide if the drug will be covered. Do not open the capsules. 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. Read on for the latest on research and when to seek medical advice. Generic name: nintedanib [nin-TED-a-nib] They also may be able to recommend tools that can make it simpler to open lids. If you have any questions, ask your doctor or pharmacist.. If you have diarrhea while taking Ofev, see your doctor right away. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Women who are able to become pregnant should have a pregnancy test before starting treatment with nintedanib. These lists do not include all possible side effects. Take nintedanib exactly as directed. Be sure to tell your doctor how you are feeling during your treatment. 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? Full article: Obstacles to early treatment of idiopathic pulmonary Do not let anyone else take your medication. Nintedanib is not a cure for IPF. Drug class: Multikinase inhibitors. Your doctor might prescribe an immunosuppressant if your lung condition is caused by an autoimmune condition. What side effects can this medication cause? This completes 1 cycle of treatment. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA If you miss a dose of nintedanib, skip the missed dose and continue your regular schedule. Your doctor may recommend oral rehydration solutions such as Pedialyte. How long a medication remains good to use can depend on many factors, including how and where you store the medication. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update. 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. The average age of the patients was 66.9 years in the Ofev 150 mg twice daily group and 66.6 years in the placebo group. Its available in two strengths: 100 milligrams (mg) and 150 mg. For information about the effectiveness of Ofev, see the Ofev uses section below. Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests. Nintedanib comes as a capsule to take by mouth. Ofev comes. If its not managed, this can lead to dehydration (low level of fluid in your body). Ofev is meant to be a long-term treatment. If you have trouble opening medication bottles, ask your pharmacist if they can put Ofev in an easy-open container. When you get Ofev from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. Ofev Oral: Uses, Side Effects, Interactions, Pictures, Warnings - WebMD FOIA Talk to your doctor about birth control methods that you can use during your treatment and for at least 3 months after your last dose of nintedanib. You should not breastfeed while using this medicine. IPF causes scar tissue to form deep within your lungs. Try to improve your sleep, for example, using extra pillows to raise you may help ease breathlessness. Ofev may not be right for you if you have certain medical conditions or other factors affecting your health. 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). Your doctor will talk to you about how many cycles of treatment you can have. 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. Follow all directions on your prescription label and read all medication guides or instruction sheets. You should not breastfeed while taking nintedanib. 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. Your doctor should do certain blood tests before you start taking this medicine. As with most drugs, some people can have an allergic reaction after taking Ofev. tell your doctor if you are breastfeeding. Ofev helps to slow down the formation of scar tissue in your lungs. To treat interstitial lung disease * with scarring, the usual dosage of Ofev is 150 mg two times per day. Ofev can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Drink plenty of liquids and call your doctor at once if you have diarrhea while taking Ofev. These lung conditions can also cause a cough and breathing difficulties, which can stop you getting enough sleep. Ofev is also used to treat chronic (long lasting) interstitial lung disease in which the scar tissue keeps getting worse. Federal government websites often end in .gov or .mil. Medically reviewed by Judith Stewart, BPharm. -, Demedts M, Behr J, Buhl R, et al. Ofev is a brand-name prescription medication. When taking more than one tablet To find out how often side effects occurred in clinical trials, see the prescribing information for Ofev. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. To read about how Ofev performed in clinical trials, see the drugs prescribing information. This was consistent with the annual rate of FVC decline in patients treated with Ofev in the INPULSIS trials (-113.6 mL/year in patients treated with Ofev). Everything you need to know about mesothelioma: Esbriet, Actemra, tocilizumab, pirfenidone, nintedanib, Actimmune, interferon gamma-1b. For more information, ask your doctor or pharmacist. Ketoconazole is an antifungal drug used to treat, Erythromycin (Eryc, Ery-Tab, Eryped). 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. Generally, nintedanib is well tolerated and effectively slows disease progression for up to 3 years. 2015 Jul;75(10):1131-40. doi: 10.1007/s40265-015-0418-6. Available for Android and iOS devices. If youre breastfeeding, talk with your doctor about other healthy ways to feed your child while youre taking Ofev. MNT is the registered trade mark of Healthline Media. 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. What special precautions should I follow? Dr. Stowasser added: "Progressive fibrosing lung diseases like IPF continue to have a devastating impact on people's lives and our focus remains on researching and bringing to market treatments that improve the lives of these patients at need.". Use this . This could increase your risk for side effects from Ofev. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. However, in clinical trials, hair loss was rare with Ofev. Other drugs may affect nintedanib, including prescription and over-the-counter medicines, vitamins, and herbal products. Nintedanib Market Recent Developments and Updates By 2030 Participants received Ofev treatment for an average period of 27.7 months, with some patients receiving the treatment for a maximum of 93.1 months. Exogenous Thymosin Beta 4 Suppresses IPF-Lung Cancer in Mice: Possibly Associated with Its Inhibitory Effect on the JAK2/STAT3 Signaling Pathway. To read more about digestive side effects, see the Ofev side effects section above. Evidence-based recommendations on nintedanib (Ofev) for adults with idiopathic pulmonary fibrosis. Nintedanib Side Effects: Common, Severe, Long Term - Drugs.com Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. Specifically, Ofev is FDA-approved to treat: Ofev contains the active drug nintedanib. You have it in the following way: Day 1 You have docetaxel as a drip into your bloodstream over 1 hour. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Nintedanib Oral: Uses, Side Effects, Interactions, Pictures - WebMD With autoimmune conditions, your immune system mistakenly attacks your bodys own healthy cells. This helps slow down the worsening of your lung function and symptoms. 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 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. -, Ley B, Collard HR, King TE., Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Last updated on Sep 20, 2022. For more information about the possible side effects of Ofev, talk with your doctor or pharmacist. Cardiovascular (major adverse cardiac and vascular events, e.g., heart attack or stroke) and bleeding exposure-adjusted event rates collected in patients who continued or initiated Ofev in INPULSIS-ON were similar to those observed in placebo-treated patients in the INPULSIS trials. The drug helps to stop your condition from progressing as quickly as it might otherwise. In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). 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. Continue reading. Nintedanib (Vargatef) | Macmillan Cancer Support Drugs. It is usually taken with food every 12 hours (twice a day). 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. Ofev is not safe to take during pregnancy. You may have diarrhea while taking Ofev. 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. Also, its important to drink plenty of fluids while you have diarrhea to help prevent dehydration. With interstitial lung disease, you have a buildup of scar tissue in the interstitium in your lungs. Ofev can cause harm, birth defects or death to an unborn baby. Ofev is available only as a brand-name medication. Call your doctor for medical advice about side effects. Lysosomes as a Target of Anticancer Therapy. Below is information on other approved uses for Ofev. Rifampin is an antibacterial drug mainly used to treat. Ofev: Side effects, cost, how it works, and more - Medical News Today It also helps keep the drug from harming the environment. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. It's recommended if breathing tests have shown your lung capacity is 50% to 80% of what would normally be expected. It can lead to fatal complications. Store nintedanib at room temperature between 68F to 77F (20C to 25C). MeSH Copyright 1996-2023 Cerner Multum, Inc. Increased risk of bleeding. We comply with the HONcode standard for trustworthy health information. Chronic Fibrosing Interstitial Lung Disease With A Progressive Phenotype, Systemic Sclerosis-Associated Interstitial Lung Disease, colony-stimulating factor 1 receptor (CSF1R). Your next few doses may be delayed based on the results. Read the Patient Information Leaflet if available from your pharmacist before you start taking nintedanib and each time you get a refill. Interstitial Lung Disease Progression - OFEV (nintedanib) Capsules Call the OPEN DOORS Patient Support Program Care Team 24/7 18666736366 About Progression Let's talk about progression and why it's an important factor to consider as you explore your treatment options. 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. Please visit www.boehringer-ingelheim.us/csr to learn more about how we make more health through our Corporate Social Responsibility initiatives. Comments: American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. 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. For more information, ask your doctor or pharmacist. Nintedanib can be taken long-term, and research has shown it is safe for up to 51 months, possibly longer. Non-receptor tyrosine kinases: Lck, Lyn, and Src kinases. The following lists contain some of the key side effects that may occur while taking Ofev. If you take too much of this medicine, call your doctor or go to the nearest hospital emergency room right away. Both Ofev and Esbriet slow IPFs worsening but do not stop its progression, and neither medication is recommended over the other. No, Ofev isnt an immunosuppressant drug. Swallow the capsules whole with liquid; do not chew or crush them. Do not take two doses at once to make up for a missed dose. It is not known if Ofev passes into your breast milk. Non-receptor tyrosine kinases: Lck, Lyn, and Src kinases. If you have fatigue, talk with your doctor about ways to manage it. The Ofev dosage your doctor prescribes will depend on several factors. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. If you and your doctor determine that Ofev is safe and effective for you, youll likely take it long term. Ofev comes as a capsule that you take by mouth. Take your doses at regular intervals, usually every 12 hours. Unless your doctor tells you otherwise, continue your normal diet. signs of a stroke - sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Try light exercise to help increase your strength (this can make activities less demanding, so you have more energy to spare). If contact with the content of the capsule occurs, wash hands immediately and thoroughly1 Or it may have no known cause. http://www.upandaway.org. Clinical use of nintedanib in patients with idiopathic pulmonary 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. Take your doses at regular intervals, usually every 12 hours. This is the drugs mechanism of action (how it works). 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. 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 . 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. Ofev can cause birth defects or death in an unborn baby. 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. Drugs. Smoking can make Ofev less effective. SOURCE Boehringer Ingelheim Pharmaceuticals, Cision Distribution 888-776-0942 You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. This causes your lung function to decline and your symptoms to worsen as the condition progresses. Using an NSAID with nintedanib may cause you to bruise or bleed easily. Both INPULSIS trials were identically designed while the TOMORROW study design was similar. The American Thoracic Society recommends Ofev as a treatment option for this condition. Careers. What side effects can this medication cause? Visit www.fda.gov/safety/medwatchor call 1-800-FDA-1088. Do not take the missed dose. 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. New study results provide evidence that Ofev (nintedanib) slows This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. They may talk to you about continuing nintedanib after finishing treatment with docetaxel. -, Bjoraker JA, Ryu JH, Edwin MK, et al. Tell your doctor about all your current medicines and any medicine you start or stop using. No up-titration upon initiation. It can also interact with certain supplements. Some Medicare plans may help cover the cost of mail-order medications. It should not be chewed, crushed, or opened. Decreased lung function can make it hard for you to breathe. Capsule Shell: gelatin, glycerol, titanium dioxide, red ferric oxide, yellow ferric oxide, black ink, Ofev If you have a sexual partner whos able to become pregnant, talk with your doctor about your birth control needs while taking Ofev. Nintedanib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Serious side effects and their symptoms can include: * For more information about this side effect, see Side effect details below. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Ask for help and accept help when offered. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. The site is secure. But if they become more severe or dont go away, talk with your doctor or pharmacist. * Sex and gender exist on spectrums. They may also temporarily reduce your Ofev dosage or ask you to stop taking Ofev until your diarrhea goes away. Do not take more than 300 milligrams of nintedanib in one day.