A Patient Information Guide My Guide to HCV treatment and care. Helpful information for patients who have been prescribed MAVIRET

Transcription

1 A Patient Information Guide My Guide to HCV treatment and care Helpful information for patients who have been prescribed MAVIRET The information in this booklet does not replace the Patient Information Leaflet that is enclosed with your prescribed medication. This information is available to view or download from

2 Contents What is MAVIRET? 4/5 How does MAVIRET work? 4 What does MAVIRET look like? 5 MAVIRET dosing 6 What dose do I need to take? 6 How do I take my tablets? 6 How long should I take my tablets for? 7 This booklet has been produced for patients who have been prescribed MAVIRET and may help answer questions that are most frequently asked. Please also read the Patient Information Leaflet that comes with the tablet packaging. This guide does not replace the Patient Information Leaflet that comes with your prescribed medicine. What should I do if I miss a dose? 8 What should I do if I lose my medication? 8 What side effects could I experience? 9 Can I take other medicines while I m taking MAVIRET? 9 Is it OK to take MAVIRET if I am pregnant? 10 Can I breastfeed while taking MAVIRET? 10 Some common questions about treatment 11 The reporting of side effects Your new medicine, like all treatments, may cause side effects a list of the more common side effects can be found on page 9 of this guide, and in the Patient Information Leaflet that comes with your tablets. Some patients don t experience any side effects at all, but it helps if you know what to look out for. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this guide or the Patient Information Leaflet. By reporting side effects you can help provide more information on the safety of this medicine. MAVIRET is subject to additional monitoring. This will allow quick identification of new safety information. You can also report side effects directly via the Yellow Card Scheme at: Does it really matter when I take my medicine? 11 How can I remember to take my medicine every day? 11 How do I store MAVIRET? 11 Will MAVIRET affect my ability to drive? 11 What is hepatitis C? 12/13 Type and genotypes 12 Taking care of your liver 13 Support groups

3 WHAT IS MAVIRET? MAVIRET is a prescription medicine used to treat adults with the 6 major types of long-term (chronic) hepatitis C (hep C). MAVIRET is a combination of two medicines, glecaprevir and pibrentasvir, that work together to attack the hep C virus and stop it from multiplying. Each tablet contains a fixed dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. How does MAVIRET work? What does MAVIRET look like? MAVIRET is an oval pink tablet, stamped on one side with NXT. What does the packaging look like? MAVIRET tablets are packed into foil blister packs containing each daily dose (3 tablets once a day). Each daily dose pack is small enough for you to conveniently carry with you. Each weekly box contains 7 of these blister packs. A monthly carton contains 4 of these weekly boxes (28 tablets in total). * If chronic hep C is untreated, the hep C virus will replicate itself inside the liver cells, increasing the number of infected liver cells. If you do not treat chronic hep C, it can, over a period of years, lead to cirrhosis (liver scarring), which can stop your liver from working. Foil blister packs / Daily dose pack Monthly carton Weekly box The combined action of your medication aims to stop the hep C virus from multiplying and infecting new cells. The hep C virus can be then cleared from your blood over a period of time. It is vital you complete your full course of treatment as directed by your healthcare professional to give your medicine the best chance of working *Tablet images are for illustrative purposes only 4 5

4 MAVIRET Dosing What dose do I need to take? How long should I take my tablets for? Whatever genotype of HCV you have (GT1-6), if you have been prescribed MAVIRET your daily dosage will be the same: Taking MAVIRET Too much MAVIRET Once daily * 3 tablets taken together, once a day. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long you need to take MAVIRET for. Do not change your dose. If you take too much MAVIRET, call your doctor or go to your nearest A&E department right away. Take the medicine pack with you so that you can show the doctor what you have taken. How do I take my tablets? With ANY food People who haven t been treated for hep C in the past, and who don t have cirrhosis, will typically need 8 weeks of treatment. It s vital you take your medication along with food as it helps the treatment to work. You can eat a snack like a banana, a yoghurt or a full meal. It s up to you. Typically, people with cirrhosis will need 12 weeks of treatment. Swallow it whole People who have genotype 3 and who have previously received treatment for hep C will typically need 16 weeks of treatment. You must not chew, crush or break the tablets. Even if you are feeling better before the end of your course, it is vital that you keep taking your medication every day unless you are told to stop by your healthcare professional. This will give you the best chance of successfully treating the virus. *Tablet images are for illustrative purposes only 6 7

5 What should I do if I miss a dose? It s very important that you take your medication every day and don t miss any doses. Use the pop-out section of this guide as directed by your doctor, to help you get into the habit of taking your medication. However, if you do miss a dose, please follow the instructions below. * What side effects could I experience? Some patients don t experience any side effects. If you are one of these people then don t worry, it doesn t mean your treatment isn t working. In clinical trials, the most common side effects included feeling very tired, headache, feeling sick, diarrhoea and feeling weak or lack of energy. Tell your doctor or pharmacist if you have any side effect that bothers you. He/she may also have some tips to help you manage any side effects. You can also report any side effects directly to: 18 hrs If you notice within 18 hours of the time you usually take MAVIRET, take the dose as soon as possible. Then take the next dose at your usual time. 18 hrs If you notice 18 hours or more after the time you usually take MAVIRET, wait and take the next dose at your usual time. DO NOT take a double dose (two doses too close together). Can I take other medicines while I m taking MAVIRET? Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Some medicines interact with MAVIRET. Keep a list of your medicines to show your doctor and pharmacists. You can ask your doctor or pharmacist for a list of medicines that may affect how MAVIRET works. Do not start taking a new medicine without telling your doctor. What should I do if I lose my medication? In the event that you lose your medication, it is important that you contact your doctor to get a new prescription as quickly as possible. Your doctor can tell you if it is safe to take MAVIRET with other medicines. Please refer to the Patient Information Leaflet for a full list of medicines you must not take or need to inform your doctor about before starting MAVIRET *Tablet images are for illustrative purposes only 8 9

6 Is it OK to take MAVIRET if I am pregnant? The effects of MAVIRET during pregnancy are not known. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as the use of MAVIRET in pregnancy is not recommended. If you fall pregnant while on treatment, we recommend you contact your doctor or nurse as soon as possible, to inform them. Some common questions about treatment Q: Does it really matter when I take my medicine? A: Absolutely. You must take your tablets as directed by your doctor. Sticking to a regular time helps to regulate the amount of active ingredients in your body across a 24-hour period. Q: How can I remember to take my medicine every day? A: There are lots of ways to help you remember to take your medication. For example, you could set a reminder on your phone or online calendar. Or you could leave post-it notes on the front door to remind you to take it before you leave for work. Or, you can use the pop-out section at the back of this booklet. Just find the method that works best for you. Q: How do I store MAVIRET? A: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after EXP. This medicine does not require any special storage. Can I breastfeed while taking MAVIRET? Q: Will MAVIRET affect my ability to drive? A: MAVIRET should not affect your ability to drive or use any tools or machines. It is not known whether the active substances (glecaprevir and pibrentasvir) in MAVIRET pass into breast milk. A risk to a breastfed baby cannot be ruled out. Your doctor will discuss this decision with you

7 Useful information What is hepatitis C? Hep C is a virus that mutates easily, meaning that every time it replicates, it has the potential to produce a slightly different version of itself. This constant changing may be why the body finds it so hard to clear the virus naturally. Taking care of your liver Even with hep C, there are plenty of things you can do to help put less strain on your liver. Talk to your doctor for advice. Avoid alcohol If you have been diagnosed with hep C, you should avoid alcohol. This is because your liver is already working hard to deal with the effects of the virus. Adding alcohol (and making your liver work even harder) can accelerate the effects of the disease. Type and genotypes There are 6 major genotypes of hep C virus, numbered 1 to 6. In the UK, genotypes 1 and 3 are most common. Eat well If you have hep C, you need to make sure you have a healthy, balanced diet including plenty of fruit and vegetables, fibre and protein - and try to cut down on fatty, fried and processed food. MAVIRET can be used to treat all 6 major genotypes. You may have been tested by your healthcare team to determine your genotype. Other medications Some medicines can cause damage to the liver so it s important that before taking any other substances, including ones you can buy without prescription, you should always discuss this with your doctor, nurse or a pharmacist. Get some exercise Exercise doesn t have to mean gym classes or sport. Getting out and about and walking is enough if you don t fancy jumping around try to exercise three times a week if you can. Always discuss with your doctor

8 Useful Contact Details Notes Your consultant How are you feeling? Name: Tel: Things to ask your doctor, pharmacist or nurse Your doctor Name: Tel: Your nurse Name: Tel: 14 15

9 SUPPORT GROUPS Your doctor or nurse can provide a variety of information to keep you informed about your condition. There are also a number of organisations that provide help, information and advice, including: British Liver Trust A UK charity with a comprehensive website that covers an array of liver-related topics. Hepatitis C Trust A UK charity providing dedicated information on all aspects of hepatitis C and living with the virus. Hepatitis Scotland Part of the Scottish Drugs Forum, a registered charity, offering support and information on hepatitis C. NHS Choices The UK s biggest health website, includes information on hepatitis C, disease management and treatment. Liver 4 Life A charity aimed at supporting anyone in the UK living with a liver condition. Waverley Care A well-established charity providing care, support and information to people in Scotland living with hepatitis C or HIV. AbbVie is not responsible for any of the content in these independent websites. Date of preparation: March 2018 AXHCV