This drug may make you dizzy. If you are a child or adolescent, your healthcare provider should perform eye examinations before and during treatment with ORKAMBI to look for cataracts. Talk to your doctor if you have been told you have liver disease as your doctor may need to adjust the dose of ORKAMBI.High liver enzymes in the blood, which can be a sign of liver injury in people receiving ORKAMBI. Ivacaftor and lumacaftor is for use only in patients with a specific gene mutation related to cystic fibrosis. Found inside Page 119Clinical trials showed that tezacaftor/ivacaftor improved lung function and QOL and had less side effects than the ivacaftor/lumacaftor combination [6062]. What should I know regarding pregnancy, nursing and administering Lumacaftor-Ivacaftor Tablet to children or the elderly? Found inside Page 807TIME/ACTION PROFILE (blood levels) ROUTE ONSET PEAK DURATION Lumacaftor within 1 lumacaftor/ivacaftor Adverse Reactions/Side Effects CNS: fatigue. Co-administration of lumacaftor-ivacaftor with sensitive CYP3A substrates or CYP3A substrates with narrow therapeutic index is not recommended. Check your blood pressure regularly and tell your doctor if the results are high. Found inside Page 195A common side effect of lumacaftor-ivacaftor is chest discomfort. F508 patients who cannot tolerate lumacaftor/ivacaftor due to side effects. Worsening of liver function in people with severe liver disease. If it is less than 6 hours until the next dose, skip the missed dose. Women who took lumacaftor/ivacaftor also had increased menstrual abnormalities such as increased bleeding. It is a single product containing 2 medications: lumacaftor and ivacaftor.Both of these components of Orkambi work by targeting the underlying genetic mutation that causes cystic fibrosis and improving the function of a naturally occurring protein. If any of these effects last or get worse, tell your doctor or pharmacist promptly. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may report side effects to Health Canada at 1-866-234-2345. Lumacaftor and ivacaftor combination is used to treat cystic fibrosis (CF) in patients 2 years of age and older. If you are taking the granules form of this medication, gently shake the packet before use. Should I avoid certain foods while taking Lumacaftor-Ivacaftor Tablet? Carvedilol: (Moderate) Concomitant use of carvedilol and lumacaftor; ivacaftor may alter the therapeutic effects of carvedilol; monitor blood pressure closely until the effects of using these drugs together are known. What are some other side effects of this drug? You and your doctor should decide if you will take ORKAMBI while you are breastfeeding, antifungal medicines including ketoconazole (such as NIZORAL, antibiotics including telithromycin (such as KETEK, every 3 months during your first year of taking ORKAMBI, pain or discomfort in the upper right stomach (abdominal) area, yellowing of your skin or the white part of your eyes, breathing problems such as shortness of breath and chest tightness>, irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding. Your doctor will do blood tests to check your liver: You or your child may be able to get these tests done during regular CF Center visits. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, because the dose of ORKAMBI may need to be adjusted when taken with certain medicines. The dosage is based on your age, medical condition, response to treatment, and other medications you may be taking. 12 Medicines That Could Help. Found inside Page 45It thus appears that the corrector lumacaftor has poorer side-effect profile than tezacaftor, rather than it being a complete class effect. Consult your doctor before breast-feeding. Stomach ache (Read More - Home remedies for stomach pain) Before you take this medicine, you may need Call your doctor for medical advice about side effects. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. Found insideThis book sheds new light on the physiology, molecular biology and pathophysiology of epithelial ion channels and transporters. Learn from their experiences about effectiveness, side effects and cost Dismiss this notification PatientsLikeMe would like to remind you that your browser is out of date and many features of the website may not function as expected. Lumacaftor/ivacaftor can commonly cause a rash that is usually not serious. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Call your doctor for medical advice about side effects. These factors may affect how you should use this medication. Things to remember when you fill your prescription. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. If you have increased blood pressure (hypertension) or a low heart rate, discuss with your doctor how this medication m cystic fibrosis with homozygous F508del genetic mutation in CFTR gene, clouding of the lens of the eye called cataracts, impaired brain function due to liver disease. Discuss the risks and benefits with your doctor. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Found inside Page 550Calcium-channel blockers: negative inotropic effect possibly increased; Ivacaftor and lumacaftor: possibly increases ivacaftor concentration reduce Monitoring requirements. Your doctor may need to change your dose of ORKAMBI or other medicines you take. Talk to your doctor about the best birth control method you should use while taking ORKAMBI, are pregnant or plan to become pregnant. Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. Sorry, we have no data available. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. Found inside Page 547 days with close attention to adverse effects) are recommended for patients who have a combination of a CFTR corrector (lumacaftor 400 mg daily) plus In this second edition of a popular and widely acclaimed collection of laboratory methods, a panel of leading authorities have thoroughly brought up-to-date and optimized its cell culture techniques for a broad range of human cell types Found inside Page 246A CFTR corrector, known as Lumacaftor, is also now clinically available in damage and side-effect in the respiratory tract (Kuzmov and Minko, 2015). Talk to your pharmacist for more details. chest pain or chest tightness. cold symptoms such as stuffy nose, runny nose, sore throat. Please contact your doctor or pharmacist. All rights reserved. It is used to treat cystic fibrosis in certain people (those with 2 copies of an abnormal "CFTR" gene). Nasal congestion. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. However, many people have no side effects or only have minor side effects. This comprehensive volume focuses on anti-inflammatory nutraceuticals and their role in various chronic diseases. Serious side effects are uncommon (may affect up to 1 in 100 people). Your doctor should monitor your blood pressure during treatment with ORKAMBI. Get information on Lumacaftor; Ivacaftor oral tablets including uses, dosage details, medication side-effects and drug interaction facts from Cleveland Clinic's health library. In Canada - Call your doctor for medical advice about side effects. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. This medication may rarely cause serious liver disease. What conditions does lumacaftor-ivacaftor oral treat? Upset stomach. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Call your doctor right away if you have any of the following symptoms of liver problems: Breathing problems such as shortness of breath or chest tightness in patients when starting ORKAMBI, especially in patients who have poor lung function. Lumacaftor (in Orkambi treatment) is available in three dosages (100 mg, 150 mg, and 200 mg) as tablets or oral granules. Comprehensive and practical, Cystic Fibrosis: Diagnosis and Protocols will provide readers with optimal working tools to address pressing questions in the best technical way, while helping all of us, as a research and clinical community, to Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Lab and/or medical tests (such as CFTR gene testing, liver/lung function, eye exams) will be done before you start taking this medication and while you are taking it. The Renal Drug Handbook offers information compiled from the UK Renal Pharmacy Group and features drug monographs guiding physicians in how to prescribe, prepare, and administer drugs to patients undergoing renal replacement therapy. You and your doctor should decide if you will take ORKAMBI while you are pregnant, are breastfeeding or planning to breastfeed. stomach pain, nausea, diarrhea; or. 2020Vertex Pharmaceuticals Incorporated | www.vrtx.com, Every 3 months during your first year of taking ORKAMBI, Pain or discomfort in the upper right stomach (abdominal) area, Yellowing of the skin or the white part of your eyes, breathing problems such as shortness of breath and chest tightness, increase in a certain blood enzyme called creatine phosphokinase, common cold, including sore throat, stuffy or runny nose, irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual, seizure medicines: phenobarbital, carbamazepine (TEGRETOL, sedatives and anti-anxiety medicines: triazolam (HALCION, immunosuppressant medicines: cyclosporine, everolimus (ZORTRESS, are using birth control (hormonal contraceptives, including oral, injectable, transdermal, or implantable forms). All other trademarks referenced herein are the propertiesof their respective owners. It is unknown if this medication passes into breast milk. You and your doctor should decide if you will take ORKAMBI while you are pregnant, Are breastfeeding or planning to breastfeed. Feeling tired or weak. It is unclear if it is useful in cystic fibrosis due to other causes. Take your next dose at the regular time. changes in vision. This medication may raise your blood pressure. This product may contain inactive ingredients, which can cause allergic reactions or other problems. You are encouraged to report side effects to FDA at 1-800-FDA-1088. Remember, it is important to know all the medicines you take. WebMD does not provide medical advice, diagnosis or treatment. Keep a list to show your doctor and pharmacist whenever you get a new medicine. Increased Liver Enzymes. It is not known if ORKAMBI will harm your unborn baby. What conditions does Lumacaftor-Ivacaftor Tablet treat? Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. This is the standard reference for prescribing and dispensing drugs. US residents can call their local poison control center at 1-800-222-1222. Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Coronavirus in Context: Interviews With Experts, Health News and Information, Delivered to Your Inbox, Treating Opioid Use Disorder With Medications, Constipated? Lumacaftor is a protein chaperone used in combination with ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the F508del mutation in the CFTR gene. See what others have said about Orkambi (Ivacaftor And Lumacaftor), including the effectiveness, ease of use and side effects. Given the general interest in CFTR, this collection will appeal to a broad readership with interests in CFTR, cystic fibrosis, ion channels and ABC transporters. Found inside fewer side effects and drugdrug interactions than lumacaftor-ivacaftor (Simon et al., 2019c). Currently, a triple combination of tezacaftor-ivacaftor Specific recommendations for monitoring are available. Lumacaftor and ivacaftor may cause other side effects. This document does not contain all possible drug interactions. Side-effects. Age 6 through 11 years: 2 tablets (each containing lumacaftor 100 mg/. Examples include rifamycins (such as rifampin, rifabutin), drugs for seizures (such as carbamazepine, phenytoin), St. John's wort, among others. Do not take ORKAMBI if you take certain medicines or herbal supplements, such as: Talk to your doctor before taking ORKAMBI if you take any of the medicines or supplements listed above. If you notice other effects not listed above, contact your doctor or pharmacist. ORKAMBI, the ORKAMBI logo, Vertex, and the Vertex triangle logo are registered trademarks of Vertex Pharmaceuticals Incorporated. Talk to your doctor if you are using marijuana (cannabis). Orkambi Side Effects Nausea, gas, or diarrhea may occur. Hormonal contraceptives should not be used as a method of birth control when taking ORKAMBI. Pharyngitis. Found insideThis book will be invaluable and entertaining for anyone who is involved in the care of patients with cystic fibrosis. breathing problems such as shortness of breath and chest tightness Gas. Selected from data included with permission and copyrighted by First Databank, Inc. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. However, many people have no side effects or only have minor side effects. Get medical help right away if you have: chest pain, shortness of breath. Lumacaftor/ivacaftor can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash. Lumacaftor/ivacaftor, sold under the brand name Orkambi among others, is a combination of lumacaftor and ivacaftor used to treat people with cystic fibrosis who have two copies of the F508del mutation. Call your doctor for medical advice about side effects. If your dose is temporarily stopped for longer than 1 week, ask your doctor for specific directions to restart this medication. Found inside Page 807TIME/ACTION PROFILE (blood levels) ROUTE ONSET PEAK DURATION Lumacaftor within 1 lumacaftor/ivacaftor Adverse Reactions/Side Effects CNS: fatigue. An increase in blood pressure in some people receiving ORKAMBI. It may help to improve breathing, reduce the risk of lung infections, and improve weight gain. 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