Biktarvy E

BIKTARVY® ▼ INFORMATION FOR PATIENTS that have been prescribed this medicine

▼ Biktarvy is subject to additional monitoring. This allows new safety information to be generated quickly. You can contribute by reporting any side effects you might get.

The package leaflet contains information on how to do this.

PREFACE Your doctor has prescribed Biktarvy for you to treat your HIV infection. This leaflet has been developed to support you when you use this medicine and to give you information on how it works.

This text does not replace the official package leaflet of the medicine, but is based on it. Your primary points of contact for information are your treating doctor, nurse practitioner and pharmacist. Contact any of them if you still have any questions after reading this leaflet.

Š Gilead Sciences Netherlands BV This text was produced on the basis of the official package leaflet in 2019. No part of this leaflet may be published or copied without permission in writing from Gilead Sciences Netherlands BV, Claude Debussylaan 22, 1082 MD Amsterdam.

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GETTING STARTED WITH BIKTARVY 7 Six important tips 8 What is HIV? 10 What is Biktarvy?

12 Warnings and precautions 13 Other medicines and Biktarvy 14 Optimal use 15 Taking Biktarvy 18 How do you know if the medicine is working?

19 Storage 20 Possible side effects 22 Pregnancy and breast-feeding 23 Co-infection

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SIX IMPORTANT TIPS 1. T ake 1 tablet per day at a specific time point. This makes it easier to remember to take your tablet every day.

2. Do not chew, crush or split the tablet.

3. If you vomit within 1 hour after taking it, take another tablet. If you vomit more than 1 hour after taking Biktarvy, you do not need to take a new tablet before your next scheduled dose.

4. It is important not to miss a dose. See page 16.

5. I f you take antacids (medicines against heartburn) containing magnesium or aluminium, or supplements containing magnesium or aluminium, take Biktarvy as follows: • at least 2 hours before, or • at least 2 hours afterwards, with food.

Iron supplements: take Biktarvy at least 2 hours before using iron supplements or take them together with food.

6. Make sure you always have a supply of Biktarvy at home. Remember to request for a prescription refill in time. If you leave home or are travelling, always take Biktarvy with you.

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WHAT IS HIV? Once the HIV virus has entered the body, it starts producing viral particles very quickly. These viral particles constantly attack the immune system, weakening it. The virus continues to attack and eventually prevents the body from being able to defend itself against diseases and infections. The onset of these diseases and infections means that the patient has developed acquired immune deficiency syndrome (AIDS).

In order to prevent or treat AIDS, it is important to treat the HIV virus early using the right medicines, to make sure that the immune system can keep doing its job. This requires the number of viral particles in the blood to be reduced to a level below standard detection (which is called undetectable viral load). That allows the number of immune cells (CD4 cells) to stay high enough. In other words, the immune system is stronger than the viral attacks.

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MORE ABOUT THE HIV VIRUS AND LIVING WITH HIV www.hivvereniging.nl

www.soaaids.nl

www.aidsfonds.nl

or ask your HIV nurse for more information.

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WHAT IS BIKTARVY? AN HIV INFECTION CAN BE TREATED WITH BIKTARVY This medicine inhibits viral replication to make sure that the number of viral particles decreases. Not only are fewer new viruses produced when the virus is controlled by the medicine, but the body stays strong enough to remove many of the remaining viral particles itself.

Biktarvy can be taken with certain medication for other diseases, however not with all medications (see chapter ‘Biktarvy and other medicines’).

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BIKTARVY CONTAINS THREE ACTIVE SUBSTANCES • Bictegravir • Emtricitabine • Tenofovir Alafenamide CAN BIKTARVY CURE YOUR HIV INFECTION? No, Biktarvy cannot cure your HIV infection.

CAN YOU SEXUALLY TRANSMIT HIV TO OTHERS WHILE YOU ARE ON BIKTARVY? The risk of sexually transmitting the HIV virus to others is virtually zero when you have an undetectable viral load (see chapter ‘What is HIV?’). Always discuss the risks of transmission with your doctor or nurse practitioner.

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WARNINGS AND PRECAUTIONS DO NOT USE BIKTARVY IF YOU ARE HYPERSENSITIVE TO ANY OF THE ACTIVE SUBSTANCES OR OTHER INGREDIENTS Always discuss this with your doctor or nurse practitioner, even if he or she does not ask you about this.

Active substances Bictegravir, emtricitabine and tenofoviral afenamide.

Other ingredients Microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), black iron oxide (E172).

TALK TO YOUR DOCTOR IF YOU HAVE OR HAVE EVER HAD LIVER PROBLEMS (HEPATITIS B OR C) Your doctor will carefully consider the best treatment regimen for you.

Additional information is available in the package leaflet.

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BIKTARVY AND OTHER MEDICINES ARE YOU TAKING ANY OTHER MEDICINES? Taking this medicine at the same time as other medicines may prevent your medicines from working properly or worsen any side effects.

MEDICINES YOU SHOULD NEVER TAKE AT THE SAME TIME AS BIKTARVY • Rifampicin • St John’s wort (hypericum perforatum).

If you use antacids (medicines against heartburn) containing magnesium or aluminium, or supplements containing magnesium or aluminium, take Biktarvy as follows: • at least 2 hours before, or • at least 2 hours afterwards, with food Iron supplements: take Biktarvy at least 2 hours before iron supplements or take them with food.

Always talk to your doctor if you are taking, have recently taken or might take any other medicines or supplements. Your doctor may need to give you other medicines or adjust the dose of the ones you are using.

Look in the package leaflet for a full list of medicines with special instructions.

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OPTIMAL USE

TAKING BIKTARVY

TAKING BIKTARVY When you take a tablet, the active substances are released into your blood via your intestines. There is enough active medicine present to inhibit the HIV virus for quite some time. The active substances nevertheless slowly disappear from your body. If you do not take a new dose, the blood level will eventually be too low to inhibit the viral particles. This has two significant disadvantages: • The viral particles may start to multiply and attack and weaken your immune system again. • The viral particles may change slightly each time they multiply, eventually creating a version of the HIV virus in your body that may be resistant to the active substances in Biktarvy.

If you take a new dose once a day, this will prevent this situation.

CHOOSE A CONVENIENT TIME OF INTAKE The recommended dose of Biktarvy is one tablet with or without food at about the same time point every day.

Taking the tablet at a time that suits you will make sure it fits in your daily schedule. If you work during the day and you do not want to tell your colleagues about your HIV status, it might be handy for you to take your medicines in the morning before work or early evening.

If you like to sleep in on the weekend, you should choose a time later in the morning or in the evening.

Talk to your doctor or nurse practitioner first if you are considering stopping your treatment with Biktarvy.

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The more convenient taking Biktarvy is for you in your daily life, the easier it will be to keep taking it and the lower the risk of forgetting a dose.

MAKING SURE YOU KEEP TRACK At times you may not remember if you have taken your daily dose. If this happens often, make sure you set up a monitoring system. There are pill organisers labelled with the days of the week, in which you can store your daily dose. There are also daily pill organiser key rings available.

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SET AN ALARM IF YOU NEED TO You can for example set an alarm on your mobile phone so that it beeps when it is time to take your tablet. There are also pill boxes with built-in alarms.

KEEP SPARE TABLETS IN DIFFERENT PLACES You may be somewhere other than expected at your scheduled time of intake. This is why you should always carry a few tablets on you, for example in one of the key rings mentioned before.

DURING YOUR HOLIDAYS Holidays often mean that your daily routine changes, especially if you are travelling to other time zones. If this happens try and maintain the 24-hour intervals between your tablets. Talk to your doctor or nurse practitioner about when it would be best to take your tablets.

MISSED A DOSE? Despite your best efforts and reminders, you may occasionally forget to take your medication. Talk to your doctor or nurse practitioner before this happens about what you should do in this situation.

In general, the following applies: If you miss a dose...

...and notice within 18 hours

...and notice after 18 hours or more

take the tablet as soon as possible

skip the missed dose

TAKE YOUR NEXT SCHEDULED DOSE AT THE USUAL TIME (WITH OR WITHOUT FOOD)

VOMITING OR DIARRHOEA? If you vomit for whatever reason within 1 hour of taking Biktarvy, take a new tablet. If you vomit more than 1 hour after taking the tablet, you do not need to take a new tablet before your next scheduled dose. If you have severe diarrhoea, there is a risk that Biktarvy is not absorbed or insufficiently absorbed by the body. You should therefore contact your doctor if you suffer from severe diarrhoea.

IF YOU HAVE TAKEN MORE THAN 1 TABLET OF BIKTARVY Immediately contact your doctor or emergency department at your nearest hospital if this happens.

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HOW DO YOU KNOW IF THE MEDICINE IS WORKING?

STORAGE Keep this medicine out of sight and reach of children.

YOUR LEVELS WILL BE REGULARLY MONITORED You will have blood tests to see whether Biktarvy works well for you.

The blood test checks how the number of viral particles (viral load) decreases and the number of immune cells (CD4 cells) increases. While you are using Biktarvy you may still get infections or other diseases related to your HIV infection.

Do not use this medicine after the expiry date stated on the pack after EXP. The last day of the month corresponds to the expiry date.

Never throw away medicines. Ask your doctor, nurse practitioner or pharmacist what you should do with tablets you no longer need to use.

Check with your doctor or nurse when your next appointment is scheduled.

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POSSIBLE SIDE EFFECTS In general, you should contact your doctor or nurse practitioner if you get any side effects, or if you notice any side effects not listed in the package leaflet.

IMMEDIATELY INFORM A DOCTOR IF YOU GET ANY OF THE FOLLOWING SYMPTOMS: Symptoms of inflammation or infection, such as a fever.

Your recovering immune system may make your body overreact to infections that did not cause symptoms before. Symptoms may include a fever, chills, severe headaches, breathlessness or exhaustion. If this happens, this will likely be in the first weeks or months of the therapy. Immediately warn your doctor or nurse practitioner if you get these symptoms.

Muscle weakness*, palpitations, tremor or hyperactivity.

These types of side effects may be triggered by the immune system attacking healthy body tissues (autoimmune disorders). They may occur long after you start taking Biktarvy.

Joint stiffness, sore muscles and problems moving.

HIV treatment may be associated with an increased risk of a bone disease called osteonecrosis.

Some users may get one or more of the side effects listed below: (Common - may affect more than 1 in 100) • Depression • Unusual dreams • Headaches • Dizziness • Diarrhoea • Nausea • Fatigue Contact your doctor if any of the side effects listed above get serious or if you are in any way unsure.

The full list of side effects, and other effects of the treatment are described in section 4 of the package leaflet.

* Weakness that starts in the hands and feet and extends to the trunk.

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PREGNANCY AND BREAST-FEEDING

CO-INFECTION

BIRTH CONTROL If you are a woman able to have children while you are on Biktarvy, you must use effective birth control to make sure that you do not become pregnant.

If you are receiving HIV treatment and you also have acute or chronic hepatitis B or C, you have a higher risk of serious and potentially fatal side effects affecting the liver.

PREGNANCY You must not use this medicine during pregnancy. If you are planning to get pregnant, ask your doctor for advice.

HEPATITIS B Biktarvy contains tenofoviral afenamide, which is also active against the hepatitis B virus (HBV). Do not stop taking this medicine without talking to your doctor or nurse practitioner. If you have chronic hepatitis B and you stop taking this medicine, your liver problems may worsen.

BREAST-FEEDING Do not breast-feed during treatment with this medicine.

This certain active substances in this medicine are excreted in breast milk.

It is also recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk.

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HEPATITIS C There is limited data on the safety and efficacy of Biktarvy in patients who have an HIV and Hepatitis C (HCV) co-infection. Your doctor will carefully consider the best treatment regimen for you.

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BIK/NL/19-03//1088 Date of preparation: March 2019

Gilead Sciences Netherlands BV Claude Debussylaan 22 1082 MD Amsterdam