Nintedanib: A Review of Its Use in Patients with Idiopathic Pulmonary Fibrosis. If you have a question that is not answered, call our free Lung HelpLine at 1-800-LUNGUSA (1-800-586-4872). This is not a complete list of side effects and others may occur. Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. Dosing & What To Expect - OFEV (nintedanib) Capsules Your pharmacist can help determine the price of Ofev. Ofev isnt known to interact with alcohol. You will need frequent medical tests to be sure nintedanib is not causing harmful effects on your liver. It can help slow down the worsening of your lung condition, but it cant cure it. The safety and tolerability of nintedanib in the treatment of idiopathic pulmonary fibrosis. Interstitial tissue (also called interstitium) is a network of tissue that runs throughout your lungs and supports the alveoli (tiny air sacs). Nintedanib is a tyrosine kinase inhibitor (TKI), which blocks enzymes in cells in the lungs called tyrosine kinases. Note: Some of the drugs listed here are used off-label to treat specific conditions. This could increase your risk for side effects from Ofev. 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. 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 can cause symptoms such as: Youll likely have other symptoms with systemic sclerosis as well. All Rights Reserved. For more information about the possible side effects of Ofev, talk with your doctor or pharmacist. Systemic sclerosis that affects your lungs is a form of interstitial lung disease. Its used to treat certain types of lung disease in adults where there is inflammation and scarring in the lungs. Before you take this medicine, tell your doctor about all of your medical conditions, including if you: The usual recommended dosage of nintedanib is a 150 mg capsule swallowed whole with liquid,taken twice daily approximately 12 hours apart. Different interactions can cause different effects. This content does not have an English version. Drink plenty of liquids and call your doctor at once if you have diarrhea while taking Ofev. Diarrhea makes your body lose more fluid and electrolytes (salts such as sodium and potassium) than usual. 2015 Jul;75(10):1131-40. doi: 10.1007/s40265-015-0418-6. Careers. This content does not have an Arabic version. You may have fatigue while taking Ofev. Yu R, Gao D, Bao J, Sun R, Cui M, Mao Y, Li K, Hu E, Zhai Y, Liu Y, Gao Y, Xiao T, Zhou H, Yang C, Xu J. Int J Mol Sci. Epub 2021 Mar 25. 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. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. Be sure to learn about the basics of PF, how it is treated, how to live well and where to get support. Ofev is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease. The Food and Drug Administration (FDA) approves prescription drugs such as Ofev to treat certain conditions. For some drugs, doing so may lead to unwanted side effects or overdose. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Ketoconazole is an antifungal drug used to treat, Erythromycin (Eryc, Ery-Tab, Eryped). Medically reviewed by Judith Stewart, BPharm. Interstitial lung disease makes breathing difficult and causes shortness of breath and fatigue. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor. Nintedanib can cause birth defects or death in an unborn a baby. The mechanical phenotypic plasticity of melanoma cell: an emerging driver of therapy cross-resistance. Varone F, Sgalla G, Iovene B, Bruni T, Richeldi L. Expert Opin Pharmacother. Ofev is not safe to take during pregnancy. If youre breastfeeding, talk with your doctor about other healthy ways to feed your child while youre taking Ofev. Or it may have no known cause. Using this service may help lower the drugs cost and allow you to get your medication without leaving home. Swallow the capsule whole and do not crush, chew, break, or open it. Previously, IPF has been managed using immunosuppressive therapy; however, it has been shown that this is associated with increased mortality. Ofev helps to slow down the formation of scar tissue in your lungs. Your dose may be decreased or treatment paused if you have side effects or changes in your liver tests. The scar tissue thickens and becomes stiff over time, which can make it harder for your lungs to work. R&D expenditure corresponds to approximately $3.4 billion (three billion euros), or 17.0 percent of its net sales. . Its not known if Ofev passes into breast milk. The following lists contain some of the key side effects that may occur while taking Ofev. HHS Vulnerability Disclosure, Help 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. Usual Adult Dose for Chronic Lung Disease: Skip the missed dose and use your next dose at the regular time. 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. You should not start taking nintedanib until a pregnancy test has shown that you are not pregnant. Nintedanib Side Effects: Common, Severe, Long Term - Drugs.com -, Bjoraker JA, Ryu JH, Edwin MK, et al. Can diet help improve depression symptoms? All these studies were randomized, double-blind, placebo-controlled trials comparing Ofev 150 mg twice daily to placebo for 52 weeks. FACT 5: Doctors and Patients Around the World Are Choosing OFEV In case of overdose, call the poison control helpline at 1-800-222-1222. Comments: It helps prevent changes to the lung tissue. Its important to have prompt diarrhea management if you have this side effect. 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. It is not known if Ofev is safe and effective in children. If you and your doctor determine that Ofev is safe and effective for you, youll likely take it long term. Drug class: Multikinase inhibitors. tell your doctor if you are breastfeeding. 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. 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. Take nintedanib exactly as your doctor tells you to take it. If youre interested in this option, check with your doctor, pharmacist, or insurance company. Continue reading. Talk with your doctor about what birth control method is right for you during this time. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Its available in two strengths: 100 milligrams (mg) and 150 mg. For information about the effectiveness of Ofev, see the Ofev uses section below. With autoimmune conditions, your immune system mistakenly attacks your bodys own healthy cells. government site. 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. National Library of Medicine Do not open the capsules. Both INPULSIS trials were identically designed while the TOMORROW study design was similar. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Everything you need to know about mesothelioma: Esbriet, Actemra, tocilizumab, pirfenidone, nintedanib, Actimmune, interferon gamma-1b. With most types of interstitial lung disease, the fibrosis in your lungs gets worse over time. Day 2 to 21 The scar tissue causes stiffness in your lungs that makes it harder for your lungs to expand when you breathe in. 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. Generic name: nintedanib [nin-TED-a-nib] If you have questions about drug interactions that may affect you, ask your doctor or pharmacist. 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. In the last 5 years, two disease-modifying agents have been licensed for use in IPF, namely pirfenidone and nintedanib. It's normally taken as capsules 3 times a day. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. It is not known if nintedanib passes into your breast milk. Uses: Fala L. Ofev (Nintedanib): First Tyrosine Kinase Inhibitor Approved for the Treatment of Patients with Idiopathic Pulmonary Fibrosis. See "Pregnancy and breastfeeding section on the page below. You should not breastfeed while taking Ofev. FVC (forced vital capacity) is a lung function test that measures the total amount of air exhaled during the forced expiratory volume (FEV) test. Specifically, Ofev is FDA-approved to treat: Ofev contains the active drug nintedanib. If you have a sexual partner whos able to become pregnant, talk with your doctor about your birth control needs while taking Ofev. If you miss a dose of nintedanib, skip the missed dose and continue your regular schedule. Call your doctor right away if you have serious side effects. Drugs. The https:// ensures that you are connecting to the Prognostic significance of histopathologic subsets in idiopathic pulmonary fibrosis. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If your local pharmacy doesnt have these options, your doctor or pharmacist may be able to direct you to one that does. Unauthorized use of these marks is strictly prohibited. This can also lead to fatigue. Tell your doctor about all your current medicines and any medicine you start or stop using. 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. For questions or assistance in accessing rifapentine, contact the TB Control Branch: 510-620-3000. 17 The effect of nintedanib on slowing FVC decline was consistent across patient subgroups defined by baseline characteristics including sex, race Patients were eligible if they had completed one of the replicate 52-week INPULSIS trials. Some may be a better fit for you than others. If you are pregnant or planning a pregnancy: If you are breastfeeding or are planning to breastfeed: Ofev Inactive ingredients: tell your doctor what herbal products you are taking, especially St. John's wort. Version: 4.01. Cell Death Dis. Nintedanib pregnancy and breastfeeding warnings, Food and Drug Administration (FDA) Ofev Capsule Product Label. Also, its important to drink plenty of fluids while you have diarrhea to help prevent dehydration. 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. It can also help prevent acute flare-ups. Do not take two doses at once to make up for a missed dose. You usually keep taking nintedanib for 20 days. In clinical trials, fatigue was common with Ofev. Below are expert answers to some common questions from patients about living with PF. In addition, trials often exclude concomitant emphysema on chest imaging, not an uncommon finding in clinical practice. In 2017, Boehringer Ingelheim achieved net sales of about $20.4 billion (18.1 billion euros). -To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. To find out how often side effects occurred in clinical trials, see the prescribing information for Ofev. 2023 Feb 11;12(1):7. doi: 10.1038/s41389-023-00452-8. 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. 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. They can tell you about other medications that may work well for you. People with IPF who are prescribed nintedanib will typically take one 150 mg tablet twice daily with food. Before taking Ofev, talk with your doctor and pharmacist. 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.