DIARRHEA AND ABDOMINAL PAIN?

Transcription

1 Irritable Bowel Syndrome with Diarrhea (IBS-D) LIVING WITH FREQUENT DIARRHEA AND ABDOMINAL PAIN? VIBERZI is a prescription medicine used to treat adults who have IBS-D. Important Risk Information VIBERZI may help VIBERZI can cause serious side effects, including: A spasm in a muscle of the digestive system (called the sphincter of Oddi), which may cause new or worsening abdominal pain. Your risk of having a spasm is increased if you do not have a gallbladder. This spasm usually happens within the first week of treatment and usually goes away when treatment is stopped. Stop taking VIBERZI and call your doctor if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting. of Medication Guide.

2 Living with IBS-D IBS-D is not the same as an occasional stomach issue. It is a condition that is long-lasting (chronic), that includes frequent episodes of diarrhea as the most common symptom, along with abdominal pain. If you re living with IBS-D, you know how unpredictable symptoms like diarrhea and abdominal pain can be. People with IBS-D can also experience gassiness and bloating. IBS-D may be more common than you think The causes of IBS-D While food or stress can often trigger IBS-D symptoms, there s more to the story. The exact causes of IBS-D are unclear, but experts believe that a few factors may be involved: 1 Muscles in the GI tract may contract too much 2 Nerves in the bowel may not respond as they should 3 Signals communicating between the bowel and the brain may be disrupted Symptoms like frequent diarrhea and abdominal pain are uncomfortable, bothersome, and frustrating. Even when they aren t present, you never know when they might come back. Doctor Discussions Do you ever feel frustrated that your symptoms keep coming back? Be sure to talk to your doctor about all your symptoms and the ways you ve tried to get ahead of diarrhea and abdominal pain. 2 3

3 4 VIBERZI may help VIBERZI is a prescription medicine for adults with IBS-D that is taken every day. VIBERZI is specifically designed for IBS-D. Taking VIBERZI helps you proactively manage 2 of the most bothersome symptoms of IBS-D diarrhea and abdominal pain. Who should not take VIBERZI? Do not take VIBERZI if you: Have or had a blockage in your gallbladder or a sphincter of Oddi problem Have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day Have had inflammation of your pancreas (pancreatitis) or other pancreas problems, including if you have had or may have had a blockage in your pancreas Have severe liver problems Have had long-lasting (chronic) or severe constipation, or problems caused by constipation Have or may have had a bowel blockage (intestinal obstruction) Talk to your doctor if you are not sure if you have any of these conditions. Important Risk Information (cont.) VIBERZI can cause serious side effects, including: Inflammation of the pancreas (called pancreatitis). Symptoms of pancreatitis usually go away when treatment with VIBERZI is stopped. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI. Stop taking VIBERZI and call your doctor if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting. VIBERZI may help you feel more in control of IBS-D symptoms Taken every day, as prescribed by your doctor, VIBERZI may provide continued symptom relief. VIBERZI makes stools less loose and watery and has been shown to reduce abdominal pain. VIBERZI has been shown to relieve the 2 main symptoms of IBS-D at the same time: 1 2 Reduces diarrhea Reduces abdominal pain VIBERZI may help you get ahead of diarrhea and abdominal pain. In clinical trials, VIBERZI helped people get IBS-D symptoms under control and keep them under control. of Medication Guide. 5

4 What should I tell my doctor before taking VIBERZI? Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you: Do not have a gallbladder Have liver problems Are pregnant or plan to become pregnant. It is not known if VIBERZI will harm your unborn baby Are breastfeeding or plan to breastfeed. It is not known if VIBERZI passes into your breast milk or could harm your baby Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VIBERZI and other medicines may affect each other, causing side effects. If you are taking VIBERZI, you should not take: How does VIBERZI work? VIBERZI is the first and only prescription therapy in a different class of medicine for IBS-D. VIBERZI acts directly in the intestine to treat the 2 main symptoms of IBS-D.* Slows the movement of food through the colon * This was seen in animal studies and the relevance to humans is not known. Reduces nerve sensitivity in the intestine Medicines that cause constipation, including: Lotronex (alosetron) Anticholinergic medicines Opioid pain medicines Ask your doctor or pharmacist for a list of these medicines if you are not sure. You may take loperamide (ie, Imodium ) occasionally to treat severe diarrhea, but avoid long-term use. Stop taking loperamide right away if you become constipated Doctor Discussions Have you ever looked for an everyday way to manage IBS-D symptoms? If so, be sure to share it with your doctor. 6 Trademarks are owned by their respective companies. of Medication Guide. 7

5 Make VIBERZI part of your everyday routine VIBERZI is 1 tablet, taken 2 times each day with food. If your doctor prescribes VIBERZI, get into the habit of taking 1 tablet in the morning and 1 tablet in the evening. Taking VIBERZI every day may help you proactively manage your symptoms of IBS-D. Doctor Discussions Are you ever frustrated by unpredictable symptoms like diarrhea and abdominal pain? Be sure to share that with your doctor. 1 tablet in the morning with food 1 tablet in the evening Stay with it with food It s important to take VIBERZI every day as your doctor prescribes. Take VIBERZI as long as your doctor recommends to continue receiving the benefits of treatment. Keep in mind that IBS-D symptoms may return if you stop taking VIBERZI. What should I avoid while taking VIBERZI? Limit your use of alcoholic drinks while you are taking VIBERZI If you have liver problems, do not drive, operate machinery, or do other dangerous activities until you know how VIBERZI affects you What are the possible side effects of VIBERZI? The most common side effects of VIBERZI include constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that lasts more than 4 days. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects. 8 of Medication Guide. 9

6 ??? Frequently asked questions Q: Will I experience constipation with VIBERZI? In clinical studies, constipation occurred in 8% of people taking VIBERZI. Severe constipation occurred in fewer than 1% of people. Stop taking VIBERZI and call your doctor if you have constipation that lasts more than 4 days. Q: Can I take Imodium (loperamide) with VIBERZI? Always talk to your doctor about other medicines you might be taking. In clinical studies, people could take Imodium as needed while also taking VIBERZI. If you are taking VIBERZI, you may take Imodium occasionally to treat severe diarrhea, but avoid long-term use. Stop taking Imodium right away if you become constipated. Trademarks are owned by their respective companies. Q: In what types of people was VIBERZI studied? VIBERZI was studied in 2 clinical trials involving more than 2400 men and women, ages 18 to 80. Q: Can VIBERZI be used in children or the elderly? It is not known if VIBERZI is safe and effective in children. VIBERZI is a prescription medicine used to treat adults who have IBS-D. Patients aged 65 years and older were included in the clinical trials. No overall differences in effectiveness were observed between adults aged 65 years and older and younger people. People aged 65 years and older had an increased number of side effects, including serious side effects and stomach problems, compared to people younger than age 65. Q: How is VIBERZI different from other medicines, like Imodium or Pepto-Bismol? Imodium and Pepto-Bismol are over-thecounter medicines for occasional use. VIBERZI is a prescription medicine that is FDA-approved for daily use in adults with IBS-D to reduce abdominal pain and diarrhea at the same time. Trademarks are owned by their respective companies. Q: What does it mean that VIBERZI is a controlled substance? VIBERZI is a federally controlled substance because it may be abused or lead to dependence. It has been designated as a substance which has a low potential for abuse and a low risk of dependence

7 If you re experiencing symptoms, talk with your doctor. It s important that you talk about all your symptoms and how long you ve been experiencing them, so your doctor can determine if VIBERZI is right for you. 1. Do you have loose or watery stools? YES Help your doctor by referring to this stool form chart. Circle the description that is most like what you re experiencing. NO DIARRHEA NORMAL CONSTIPATION Watery, no solid pieces (entirely liquid) Fluffy pieces with ragged edges, a mushy stool Soft blobs with clear-cut edges (passed easily) Like a sausage or snake, smooth and soft Like a sausage but with cracks on surface Sausage-shaped but lumpy Separate hard lumps like nuts (difficult to pass) 2006 The Rome Foundation, Inc. 2. How many times per week do you have loose or watery stools? 3. Do you experience abdominal (stomach) pain? 4. Have you had the symptoms above for at least 3 months or more? 5. Do your symptoms keep coming back? YES YES YES NO NO NO of Medication Guide. Allergan and its design are trademarks of Allergan, Inc. VIBERZI and its design are trademarks of Furiex Pharmaceuticals, LLC, an Allergan affiliate Allergan. All rights reserved. VBZ /16

8 Brief Summary of the Medication Guide VIBERZI (vye BER zee), CIV (eluxadoline) tablets This information does not take the place of talking with your doctor about your medical condition or your treatment. What is VIBERZI? VIBERZI is a prescription medicine used to treat adults who have irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a controlled substance (CIV) because it contains eluxadoline that can be a target for people who abuse prescription medicines or street drugs. Keep your VIBERZI in a safe place to protect it from theft. Never give your VIBERZI to anyone else, because it may harm them. Selling or giving away this medicine is against the law. It is not known if VIBERZI is safe and effective in children. People 65 years old and older have had an increased number of side effects, including serious side effects and stomach problems, while taking VIBERZI than people younger than 65 years old have had. What is the most important information I should know about VIBERZI? VIBERZI can cause serious side effects, including: Sphincter of Oddi spasm. A spasm in a muscular valve of the digestive system (called the sphincter of Oddi), which may cause new or worsening stomach area (abdomen) pain. Your risk of having a spasm is increased if you do not have a gallbladder. This spasm usually happens within the first week of treatment with VIBERZI and usually goes away when treatment with VIBERZI is stopped. Inflammation of the pancreas (pancreatitis). Symptoms of pancreatitis usually go away when treatment with VIBERZI is stopped. Your risk of getting pancreatitis is increased if you drink more than 3 alcoholic drinks a day. Limit your use of alcoholic drinks while you are taking VIBERZI. Stop taking VIBERZI and call your doctor if you have new or worsening stomach-area (abdomen) pain or pain in the upper right side of your stomach-area (abdomen) that may move to your back or shoulder, with or without nausea and vomiting. Who should not take VIBERZI? Do not take VIBERZI if you: have or may have had a blockage in your gallbladder or a sphincter of Oddi problem have or had problems with alcohol abuse, alcohol addiction, or drink more than 3 alcoholic drinks a day have had inflammation of your pancreas (pancreatitis) or other pancreas problems, including if you have had or may have had a blockage in your pancreas have severe liver problems have had long-lasting (chronic) or severe constipation, or problems caused by constipation have or may have had a bowel blockage (intestinal obstruction) Talk to your doctor if you are not sure if you have any of these conditions. What should I tell my doctor before taking VIBERZI? Before taking VIBERZI, tell your doctor about all of your medical conditions, including if you: do not have a gallbladder have liver problems are pregnant or plan to become pregnant. It is not known if VIBERZI will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if VIBERZI passes into your breast milk or could harm your baby. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine. VIBERZI and other medicines may affect each other causing side effects. If you are taking VIBERZI you should not take: medicines that cause constipation including: o Lotronex (alosetron) o anticholinergic medicines o opioid pain medicines Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Avoid taking loperamide, a medicine used to treat diarrhea, for a long time (chronic use). You may take loperamide occasionally to treat severe diarrhea. Stop taking loperamide right away if you become constipated. How should I take VIBERZI? Take VIBERZI exactly as your doctor tells you to take it. Take 1 tablet of VIBERZI 2 times each day with food. If you miss a dose, take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose. Do not change your dose or stop taking VIBERZI unless your doctor tells you to. If you take too much VIBERZI, call your doctor or go to the nearest hospital emergency room right away. What should I avoid while taking VIBERZI? Limit your use of alcoholic drinks while you are taking VIBERZI. If you have liver problems, do not drive, operate machinery, or do other dangerous activities until you know how VIBERZI affects you. What are the possible side effects of VIBERZI? The most common side effects of VIBERZI include: constipation, nausea, and abdominal pain. Stop taking VIBERZI and call your doctor if you have constipation that lasts more than 4 days. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA Keep VIBERZI and all medicines out of the reach of children. Need more information? This section summarizes the most important information about VIBERZI. If you would like more information, talk with your doctor. Go to or call VIBERZI TM and its design are trademarks of Furiex Pharmaceuticals, LLC, an Allergan affiliate. Distributed by: Actavis Pharma, Inc. Parsippany, NJ USA Actavis All rights reserved. ELX /15