VIEKIRA PAK and VIEKIRA PAK-RBV *

Transcription

1 VIEKIRA PAK and VIEKIRA PAK-RBV * Information for people living with hepatitis C *RBV = ribavirin September 2017 Update

2 The information in this booklet is for people with hepatitis C who have been prescribed VIEKIRA PAK or VIEKIRA PAK-RBV. It does not replace the advice given by your doctor, nurse, or pharmacist. More information about VIEKIRA PAK or VIEKIRA PAK-RBV can be found in the Consumer Medicine Information leaflets which are available from your pharmacist, and

3 CONTENTS IMPORTANT CONTACTS AND DATES TO REMEMBER 2 WHAT DO I NEED TO TELL MY DOCTOR? 3 VIEKIRA PAK AND VIEKIRA PAK-RBV 4 HOW DO I TAKE MY TABLETS? 5-6 WHAT IF I TAKE TOO MUCH (OVERDOSE)? 6 WHAT IF I MISS A DOSE? 7 WHAT SIDE EFFECTS CAN I EXPECT? 8-9 HOW DO I COLLECT MY MEDICINE FROM THE PHARMACY? 10 WHAT APPOINTMENTS AND TESTS WILL I HAVE DURING TREATMENT? 10 WHAT IF I NEED TO SEE ANOTHER DOCTOR? 10 IDEAS TO HELP DURING TREATMENT WHAT HAPPENS AT THE END OF MY TREATMENT? 14 THINGS TO REMEMBER AFTER TREATMENT 15 IMPORTANT INFORMATION ABOUT VIEKIRA PAK AND VIEKIRA PAK-RBV 16 1

4 IMPORTANT CONTACTS Name Contact details SPECIALIST NURSE PHARMACIST GP OTHER Instructions or advice from my doctor, nurse or pharmacist: If you need help, the best person to call is your doctor or nurse. If it s an emergency, go directly to your nearest hospital. There is also the option to call Healthline on for additional free advice from trained registered nurses. For ongoing support, you could call the Hepatitis Foundation of New Zealand on or go to The Hepatitis Foundation offers information, support, and links to other healthcare organisations in your community. If you are looking after someone receiving treatment for hepatitis C, and need support, you could call Carers NZ on , or go to DATES TO REMEMBER TREATMENT START DATE BLOOD TESTS CLINIC VISITS PHARMACY VISITS TREATMENT END DATE BLOOD TEST 12 WEEKS AFTER TREATMENT 2

5 WHAT DO I NEED TO TELL MY DOCTOR? Interactions with other medicines 1,2 Because medicines can interact with each other, it is important to tell your doctor, nurse, and pharmacist about all the medicines you are taking, including inhalers, creams, or the oral contraceptive pill. Also tell them about any supplements and remedies that you buy without a prescription from your pharmacy, supermarket, or health-food store. For example, St John s wort may reduce the effectiveness of your treatment and shouldn t be taken at the same time. VIEKIRA PAK and VIEKIRA PAK-RBV can also interact with illicit drugs, increasing the risk of a drug overdose. 3 Don t start any new medicines without talking to a healthcare professional about whether they are safe to use at the same time as your treatment for hepatitis C. During your treatment, it is safest to avoid using any medicines or drugs that you have not discussed with your doctor, nurse, or pharmacist. Pregnancy and breastfeeding 1,2 Tell your doctor if you are pregnant or planning to become pregnant, or if your partner is pregnant or planning to become pregnant. VIEKIRA PAK is not recommended in pregnancy. VIEKIRA PAK-RBV must never be taken while you or your partner are pregnant. Two reliable forms of contraception must be used during treatment with VIEKIRA PAK-RBV, and for 6 months after finishing this treatment. Some contraceptives should not be taken during treatment, so your doctor may ask you to change your contraceptive. Do not take VIEKIRA PAK or VIEKIRA PAK-RBV if you are breastfeeding or plan to breastfeed. Hepatitis B 1,2 Tell your doctor if you have ever had hepatitis B or other liver problems. 3

6 VIEKIRA PAK 4 VIEKIRA PAK is a medicine for adults who have chronic hepatitis C, a virus which damages the liver. VIEKIRA PAK is only for a specific type of the hepatitis C virus known as Genotype 1. VIEKIRA PAK is a combination medicine which fights the hepatitis C virus in three different ways. There are two types of tablets in VIEKIRA PAK, which are packaged together in daily blister packs: pink tablets containing paritaprevir, ritonavir, and ombitasvir beige dasabuvir tablets VIEKIRA PAK-RBV 5 Some people need to have another medicine called ribavirin (RBV) added to their VIEKIRA PAK. Your doctor will decide whether you need ribavirin, and if so, how much. Blue ribavirin tablets come in a plastic bottle inside the VIEKIRA PAK-RBV monthly carton. 4

7 HOW DO I TAKE MY TABLETS? 1,2,4,5 Take three tablets (two pink and one beige) in the morning and one tablet (beige) in the evening. AM PM + + FOOD + FOOD If you also need to take ribavirin tablets, your doctor or nurse will explain how many blue ribavirin tablets you need to take each morning and evening. Eat some food within half an hour of taking the tablets the medicine works better if you do. It s up to you whether you eat a snack or a full meal, and what kind of food to eat. Swallow your tablets whole with a glass of water do not chew, crush or break them. Take your tablets at about the same times every morning and every evening. 97% of people who take VIEKIRA PAK or VIEKIRA PAK-RBV as directed can expect to be cured of their hepatitis C, meaning that the hepatitis C virus has been cleared from the body. 4,5 5

8 Your pharmacist will give you a dosage card with your medicine. You may find it useful to keep this card with you at all times (e.g. in your wallet) to help you to remember when to take which tablets. How to take your medicine Each morning Each evening VIEKIRA PAK VIEKIRA PAK Take two pink tablets and one beige tablet Ribavirin Take blue tablets Reporting of side effects Take one beige tablet Ribavirin Take blue tablets It is a good idea to write down the date that you take your first tablets (start date of your treatment) on page 2 of this booklet. Most people take VIEKIRA PAK or VIEKIRA PAK-RBV for 12 weeks (3 months). Some people only need VIEKIRA PAK for 8 weeks (2 months) and some people need VIEKIRA PAK-RBV for 24 weeks (6 months). Your doctor will tell you how long your treatment needs to be. 4,5 Your doctor may adjust your dose of ribavirin (blue tablets) during your treatment. If your ribavirin dose changes, please note the changes on your dosage card, or ask for a new card. Even if your ribavirin changes or stops, your VIEKIRA PAK (pink and beige tablets) will not change. 5 Follow all directions given to you by your doctor, nurse, and pharmacist. Tablets are for illustrative purposes only. WHAT IF I TAKE TOO MUCH (OVERDOSE)? 1,2 Immediately telephone your doctor, call the Poisons Information Centre on telephone [0800 POISON], or go to your nearest Accident and Emergency. Have your tablets and dosage card with you. 6

9 WHAT IF I MISS A DOSE? 1,2 Missing doses can reduce the effectiveness of your treatment and your chance of being cured. Time since dose was missed: Less than 12 hours Take the missed dose with food as soon as possible. More than 12 hours Do NOT take the missed dose. Simply take your next dose at the usual time. Time since dose was missed: Less than 6 hours Take the missed dose with food as soon as possible. More than 6 hours Do NOT take the missed dose. Simply take your next dose at the usual time. If you miss a dose a ribavirin: Do NOT take the missed dose. Simply take your next dose at the usual time. If you miss a dose of your medicine, make a note, and let your doctor or nurse know the next time you speak to them. If you vomit, keep taking your medicine at the usual times, but tell your doctor or nurse as soon as possible. If you feel concerned, go to Accident & Emergency, and take your medicine and dosage card with you. 1,2 Do not share your treatment with anyone else. Your doctor has prescribed a specific dose of VIEKIRA PAK or VIEKIRA PAK-RBV for you. It may not be effective for someone who has a different type of hepatitis C, and you need to take all of your tablets to give your treatment the best chance of working. 1,2 7

10 WHAT SIDE EFFECTS CAN I EXPECT? All medicines can have side effects. Medicines can affect different people in different ways. Not everyone will have side effects but knowing what to look out for may help you to manage them if you do. VIEKIRA PAK and VIEKIRA PAK-RBV have fewer side effects than older treatments for hepatitis C. 6 Most of the side effects are mild. About 1% of people (one in a hundred) are likely to stop their treatment because of side effects. 4,5 VIEKIRA PAK: likelihood of common side effects 4 Fatigue (tiredness) 20-30% Insomnia (trouble sleeping), itchy skin or nausea 5-10% VIEKIRA PAK-RBV: likelihood of common side effects 5 Fatigue (tiredness) 30-40% Nausea 20-30% Insomnia (trouble sleeping), itchy skin or weakness 10-20% Anaemia 5-10% Decreased appetite, dizziness, diarrhoea, dry skin, headaches, rash or vomiting Less than 5% You may not experience any of these side effects. Don t worry this doesn t mean your treatment isn t working. More information about side effects is available in the Consumer Medicine Information leaflets, which are available from your pharmacist, or 8

11 If you are bothered by any side effects, tell your doctor, nurse, or pharmacist as soon as possible. They may be able to help you manage the side effects. For example, your doctor might adjust your dose of ribavirin (blue tablets) if you experience anaemia. Serious signs of liver failure 1,2 Go to your nearest Accident & Emergency if you notice: signs of internal bleeding (pain in your abdomen, blood in your stool or vomit, or coughing blood) bruising, swelling, or fluid in the feet, legs, or stomach feeling unusually confused jaundice (yellowing of the eyes and skin). Take your tablets and dosage card with you. Allergic reactions are very uncommon, but they can be serious. Seek medical help immediately if you experience shortness of breath or trouble breathing, tightness in your chest, or swelling of your face, lips, or tongue. 1,2 Take your tablets and dosage card with you. 9

12 HOW DO I COLLECT MY MEDICINE FROM THE PHARMACY? You can only get VIEKIRA PAK and VIEKIRA PAK-RBV from certain pharmacies (AbbVie Care pharmacies). Talk with your doctor or nurse to choose the most convenient AbbVie Care pharmacy for you. You will stay with the same pharmacy throughout your whole treatment. After the doctor writes your prescription, it may take up to a week for the medicine to be delivered to the pharmacy. The pharmacist will contact you when your medicine is ready for you to collect. You will need to take your prescription with you when you go to the pharmacy. You will get a 1-month supply of medicine each time you visit, until you finish your treatment. You will not have to pay pharmacy fees when you collect your VIEKIRA PAK or VIEKIRA PAK-RBV each month. WHAT APPOINTMENTS AND TESTS WILL I HAVE DURING TREATMENT? Your doctor or nurse may ask you to return to the clinic during your treatment. You can enter the dates and times of these appointments on page 2 of this booklet or in your calendar. If you miss an appointment for a visit, please call the clinic staff to book another time as soon as you can. You may need to have blood tests (e.g. for haemoglobin or liver function). Your doctor or nurse will give you a form (or forms) to take to the laboratory for any tests that you need during treatment. Keep your forms in a safe place and remember to take them with you when you go for your blood tests. WHAT IF I NEED TO SEE ANOTHER DOCTOR? If you see any other healthcare professional during treatment or have to go to hospital, tell them about your treatment for hepatitis C, and show them your dosage card. It is very important to remember that other medicines can interact with your hepatitis C treatment. If a different healthcare professional wants you to stop your treatment with VIEKIRA PAK or VIEKIRA PAK-RBV or change your dose, ask them to discuss this with the doctor who prescribed your treatment. 10

13 IDEAS TO HELP DURING TREATMENT Take your tablets at around the same time every day so that it becomes a habit. Link taking your tablets to something you normally do (e.g. if you always have a morning coffee, keep your tablets next to the kettle). Put reminder notes where you ll see them every day (e.g. on the fridge door or bathroom mirror). Set daily reminders in your phone. To help you remember when you need to visit the clinic or have any blood tests, enter the appointments in your calendar, and on page 2 of this booklet. You could also set reminders in your phone. Remember that every dose you take is another step towards your wellbeing and towards clearing the virus from your body. Set goals for the activities you d like to enjoy once your treatment is complete. If you will be travelling or away from home: Don t forget to pack your tablets. Check that you have enough tablets to last you while you re away, and if you need to, ask your pharmacist if you can pick up your next month s supply of tablets early. Think of ways to remind yourself to take your tablets when you re not in your usual routine at home. For example, attach a reminder note to your toiletries bag or another item you ll use every day. Consider telling close friends, flatmates, and family members that you will be starting treatment. For some people, taking tablets regularly can be challenging, so you could ask someone else to help you: plan a schedule for taking your tablets remind you to take tablets on time (e.g. by text message or phone call) talk about your goals and the benefits of clearing the virus write down any questions or concerns to discuss with your healthcare professional 11

14 go with you to doctor s appointments and for blood tests listen and offer encouragement and motivation assist with everyday living activities support lifestyle changes such as cooking healthy meals, exercising regularly, and avoiding alcohol and drugs. Consider talking to your manager or someone else you work with. This might help if you are finding the treatment difficult and need some extra support (e.g. time off work if you experience any side effects or need to go for blood tests or clinic visits). Whether or not you experience symptoms from hepatitis C, a healthy lifestyle can help your overall wellbeing while you are on treatment. 7 Get active Just 30 minutes a day of moderate physical activity, on most days of the week, will do your body good and boost your mood even if you re feeling unwell. You don t have to join a gym. Even short bursts of activity (e.g. 10 or 15 minutes of walking or gardening) can give your health a boost. Make time for rest Adequate rest is essential for good health and quality of life. As a general rule, most healthy adults need 7 to 9 hours of sleep each night. If you have trouble sleeping, it can help to establish a routine at the same time each day, by using relaxation techniques and dim lights to unwind in the evening before bed. Try to remove distractions from your bedroom, and to ensure it s at a comfortable temperature. You may also need to make time to take the occasional nap during the day. 12

15 Eat well Some people living with hepatitis C find that changing their diet makes them feel better. Talk to your doctor or nurse about healthy diet options which are appropriate for you. DO eat or drink: Plenty of vegetables and fruit. Choose a variety of types and colours. They can be fresh, frozen, or canned (low-salt). Wholegrain versions of foods such as breads, cereals, and pasta. Lean cuts of meat and poultry. Fish (especially oily fish like salmon and tuna). This can be fresh, frozen or canned (low-salt). Eggs, tofu, beans, nuts, and seeds. Reduced fat versions of milk, yoghurt, cheese and other dairy products. AVOID eating or drinking: Foods high in saturated fat, such as biscuits, chips, pies, fried foods, pizza, and processed meat like ham. Foods and drinks which have added salt or sugar (e.g. soft drinks). Alcohol, which can damage your liver. You should try to reduce alcohol to a minimum during your treatment, particularly if your liver disease is already advanced, since alcohol can damage your liver. 8 It is safest if you don t use drugs during your treatment. 3 Discuss with your doctor, nurse, or pharmacist if you might need extra support to do this, or have any questions. 13

16 WHAT HAPPENS AT THE END OF MY TREATMENT? It is a good idea to make a note of the date you take your last tablets on page 2 of this booklet (end date for your treatment). You will need to have a blood test 12 weeks after you finish your treatment to check whether you are cured of hepatitis C. 3 Make sure you enter the date in your calendar and on page 2 of this booklet. You could also set a reminder in your phone. Once the test results come back, your doctor will explain them to you. When you get your results, there is a small chance that you will find out that the hepatitis C virus has not been cleared. If this is the case, you will probably feel disappointed and frustrated that you are not cured. Talk to your doctor and nurse about your options, and how you can continue to look after your liver. It may also help to talk with close friends and family. If you have been taking VIEKIRA PAK-RBV, you may have some ribavirin tablets left in the bottle after you finish the VIEKIRA PAK tablets. You can return these ribavirin tablets, and any other left-over tablets, to your pharmacist for safe disposal. 14

17 THINGS TO REMEMBER AFTER TREATMENT If you are successfully treated and clear the virus from your body, you still need to be careful to protect your liver and avoid further damage. 8 Stay in touch with your healthcare team and go for any follow-up visits or tests they advise. Ask your doctor whether you need a vaccine against hepatitis A or B. 9 Look after your health by prioritising a good diet, regular exercise, and plenty of rest. 7 It s also possible to get reinfected if you are exposed to the virus again. Remember that hepatitis C is spread through blood-to-blood contact. You can take simple steps to lessen the risk of contact between your blood and someone else s: 6 Don t share needles or other injecting equipment, Don t have unprotected sex, Don t share or reuse equipment for tattooing or body piercing, Don t share personal toiletry items and replace them regularly (e.g. razors, toothbrushes, or nail clippers), Keep any cuts or open wounds clean and covered, Avoid contact with blood. References 1. VIEKIRA PAK Consumer Medicine Information. Medsafe, Wellington: August Available at 2. VIEKIRA PAK-RBV Consumer Medicine Information. Medsafe, Wellington: August Available at 3. New Zealand Society of Gastroenterology HCV Treatment Guidelines. 4. VIEKIRA PAK Data Sheet. Medsafe, Wellington: August Available at 5. VIEKIRA PAK-RBV Data Sheet. Medsafe, Wellington: August Available at 6. Hepatitis Foundation of New Zealand. Available at 7. WebMD. Available at 8. Mayo Clinic. Available at 9. Immunization action coalition. Available at 15

18 IMPORTANT INFORMATION ABOUT VIEKIRA PAK AND VIEKIRA PAK-RBV VIEKIRA PAK and VIEKIRA PAK-RBV are fully funded prescription medicines with an alternative arrangement on how they are available to you. Your prescriber will explain this to you. VIEKIRA PAK and VIEKIRA PAK-RBV are used to treat some types of chronic (longlasting) hepatitis C in adults. Ask your doctor if these medicines are right for you. Normal doctor s charges will apply. Always use strictly as directed. If symptoms persist or you have side effects, see your healthcare professional. Please refer to the Consumer Medicine Information that is available from your pharmacist, from or from the Medsafe website VIEKIRA PAK is a combination therapy containing two different types of tablets: ombitasvir/ paritaprevir/ritonavir (12.5/75/50 mg) tablets and dasabuvir (250 mg) tablets. VIEKIRA PAK-RBV is a combination therapy containing three different types of tablets: ombitasvir/paritaprevir/ritonavir (12.5/75/50 mg) tablets, dasabuvir (250 mg) tablets, and ribavirin (200 mg) tablets. The following information applies to both VIEKIRA PAK and VIEKIRA PAK-RBV VIEKIRA PAK and VIEKIRA PAK-RBV include medicines called direct-acting antiviral agents, which have risks and benefits. You must not take them if you are allergic to any of the individual medicines or to any of the inactive ingredients. Do not take them if you have decompensated liver disease or severe liver impairment (Child-Pugh C). Some medicines and VIEKIRA PAK or VIEKIRA PAK-RBV may interfere with each other, so tell your doctor or pharmacist if you are taking any other medicines. Do not take VIEKIRA PAK or VIEKIRA PAK-RBV if you take a medicine that contains any of the following: atorvastatin, carbamazepine, colchicine (if you have certain liver or kidney problems), efavirenz, ergotamine or its derivatives, ethinyloestradiol-containing medicines (e.g. combined oral contraceptives), fusidic acid, gemfibrozil, midazolam (taken by mouth), phenobarbital, phenytoin, ranolazine, rifampicin, St. John s wort, salmeterol, sildenafil (when used for pulmonary arterial hypertension), simvastatin, terfenadine, or triazolam. See Consumer Medicine Information leaflets for a complete list of medications for which there is a warning. Do not give VIEKIRA PAK or VIEKIRA PAK-RBV to children or adolescents under 18 years of age. Tell your doctor about any other medical conditions you have or have had, especially hepatitis B, HIV, a liver transplant, or any other liver disease. Tell your doctor about any current or previous treatments for your hepatitis C. Tell your doctor, and do not take VIEKIRA PAK or VIEKIRA PAK-RBV if you or your partner are pregnant, breastfeeding, or plan to breastfeed. Tell your doctor or healthcare professional if you do not feel well when taking VIEKIRA PAK or VIEKIRA PAK-RBV. Some of the more common side effects of treatment include: fatigue, nausea, itching, trouble sleeping, and unusual weakness or lack of energy. The following information applies only to VIEKIRA PAK-RBV Ribavirin may cause birth defects or death of an unborn baby. Therefore, you must not take VIEKIRA PAK-RBV if you or your partner are pregnant, and you must take extreme care to avoid pregnancy during treatment and for 6 months after completion of treatment with ribavirin. Females and males must use two reliable forms of contraception during this time. Do not take VIEKIRA PAK-RBV if you have had severe heart problems in the last 6 months, or have a red blood cell disorder, like thalassaemia or sickle-cell anaemia. Tell your doctor or pharmacist if you have or have had heart problems, gout, severe liver disease, or kidney disease. The most common side effects with VIEKIRA PAK-RBV include tiredness, looking pale, diarrhoea, vomiting, loss of appetite, dizziness, headache, cough, shortness of breath, dry skin, and rash. AbbVie is a registered Trademark of AbbVie Inc. VIEKIRA PAK is a registered Trademark of AbbVie Ireland Unlimited Company AbbVie Limited, PO Box 11437, Manners Street, Wellington 6142, New Zealand. ABB0126. NZ-HCV TAPS PP1384. Prepared Sept

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