Starting with Tivicay (dolutegravir) Read the package leaflet thoroughly before you use Tivicay. PATIENT INFORMATION
Introduction You have been given this brochure because you will be using Tivicay and other medicines to inhibit the replication of HIV. This brochure together with the package leaflet contains the most important information you need when starting your therapy. The decision to use HIV replication inhibitors is an important one. HIV replication inhibitors can keep the virus under control for a long time, but do demand something from you: it is very important that you take your medication on time every day, even if you do not feel ill at all. This is called adherence. If you skip your pills, or take them too late, your HIV replication inhibitors may stop working eventually. If you are very adherent, you maximise the chance that Tivicay taken together with other antiretrovirals will work for a long time. This brochure is designed to help you with this. 2
Your doctor and your HIV consultant/nurse can help you with all of the topics covered in this brochure. If there is something you do not understand, if you have doubts about what to do or if you are having difficulties with the treatment, you can ask them for information, advice or support. IT IS VERY IMPORTANT THAT YOU TAKE YOUR MEDICATION ON TIME EVERY DAY 3
What is Tivicay? One Tivicay pill contains 10 mg, 25 mg or 50 mg dolutegravir. Dolutegravir inhibits the replication of HIV. There are currently 6 classes of HIV drugs. Each group suppresses the virus in a different way. Tivicay belongs to the group of integrase inhibitors. Combined with other HIV replication inhibitors, Tivicay ensures that the amount of virus in your blood (viral load) is reduced. Purpose of antiretroviral therapy The purpose of antiretroviral therapy is to reduce the HIV viral load as much as possible preferably to undetectable levels as long as possible. If the amount of virus in your blood is so low that it is almost impossible to measure, the treatment is successful. This will allow your immune system to recover, making you less prone to diseases. 4
6 mm 10 mg White, round, biconvex tablet, approximately 6 mm in diameter 7 mm 25 mg Light yellow, round, biconvex tablet, approximately 7 mm in diameter 9 mm 50 mg Film-coated tablet (Yellow, round, biconvex tablets, approximately 9 mm in diameter) 5
How often per day? Always use this medication as prescribed. Are you in doubt about the correct use? Please contact your doctor or pharmacist. TAKE THE TABLET WITH SOME WATER For patients with resistance to the integrase class (documented or clinically suspected), a different dosage may be required as instructed by your doctor. 6
What time? You decide at what time you want to take Tivicay, but your HIV consultant/nurse can advise you about the ideal situation for you. It is practical to take Tivicay together with your other HIV medicines. Choose a schedule that makes it as easy as possible to take your pills at the same time every day. Many people living with HIV use a weekly pill organiser. if their tablets storage instructions allow this. This means you only need to sort out your pills once a week, and you can easily check if you have already taken your medication. Some people use an alarm (eg, on a mobile phone) to help them remember to take their medication on time. Your HIV consultant/nurse can advise you on pill organisers and the use of an alarm. Also, discuss what you need to do when travelling to a country in a different time zone. 7
Have you forgotten to take Tivicay? If you forget to take your medication, take it as soon as possible and return to your usual schedule again. However, if your next dose is scheduled to be taken within 4 hours, skip the missed dose and continue your usual schedule. Do not take a double dose to compensate for the one you missed. If in doubt, contact your doctor or HIV consultant/nurse. 8
Have you taken too much Tivicay? If you have taken too many Tivicay pills, please contact your doctor or pharmacist for advice. Show them the Tivicay packaging if possible. 9
What are the possible side effects of Tivicay? All medicines may cause side effects, including Tivicay. It is impossible to predict whether you will experience side effects and how long they will last if you do. This is different for everybody. A complete overview of the possible side effects is listed in the package leaflet. Always inform your doctor, HIV consultant/nurse or pharmacist about all side effects that you experience. VERY COMMON SIDE EFFECTS ARE: HEADACHE, DIARRHOEA, NAUSEA. 10
Never stop without consulting a doctor Taking your HIV medication on time every day increases the chance of successful longterm treatment against HIV. If you stop without discussing it with a doctor or without supervision, you run the risk of reducing your chances of successful treatment in the future because certain medicines will no longer work (well). DO NOT STOP USING TIVICAY WITHOUT CONSULTING YOUR DOCTOR OR HIV CONSULTANT/NURSE 11
Can I use other medicines together with Tivicay? You are using other HIV replication inhibitors together with Tivicay, but you may also be using other medication. Some medicines can affect how well Tivicay (dolutegravir) works or increase the chances of side effects. 12
Tivicay can also affect how other medicines work. Tivicay must not be given together with dofetilide, as it may cause serious side effects. The package leaflet contains a list of medicines that you must tell your doctor or HIV consultant/nurse about if you are using them. The dose can be adjusted if necessary however some combinations are not allowed. Inform your doctor about all other medications that you are using. This is also true for medicines available without a prescription from the pharmacy. For example, simultaneous use with St John s wort is strongly discouraged. Magnesium/aluminiumcontaining antacid, calcium supplements, iron supplements or multivitamins should be taken well separated in time from the administration of Tivicay (Tivicay should be taken a minimum of 2 hours before or 6 hours after these medicines). 13
The pharmacy In addition to Tivicay, your doctor also prescribed other HIV medicines. Only start when you have a supply of all different HIV medicines you have been prescribed. This is to avoid running out of one of the prescribed HIV medicines and not being able to take the full prescribed combination of HIV medicines. ASK YOUR DOCTOR FOR: A new prescription on time A prescription that extends longer than the exact day of your next appointment Hand in your prescription to the pharmacy on time. 14
How do I store Tivicay? Keep Tivicay out of the sight and reach of children. Tivicay 10 mg film-coated tablets: Store in the original package in order to protect from moisture. Keep the container tightly closed. Do not remove the desiccant. This medicinal product does not require any special temperature storage conditions. Tivicay 25 mg and 50 mg film-coated tablets: This medicinal product does not require any special storage conditions. Do not use Tivicay after the expiry date stated on the box and the bottle after the letters EXP. Do not throw away any medicines via wastewater or household waste. Take medicines you are no longer using back to the pharmacy. 15
Doctors and HIV consultants/nurses can request additional brochures from GSK/ViiV Healthcare. DATE OF PREPARATION: JANUARY 2018 SE/DLG/0005/17A GSK, BOX 516, 169 29 SOLNA. TFN. 08-638 93 00 se.gsk.com TIVICAY is a registered trademark of the ViiV Healthcare Group of Companies. 2015 ViiV Healthcare group of companies All rights reserved.