Genvoya english

GENVOYA®

INFORMATION FOR PATIENTS

INFORMATION FOR PATIENTS

PREFACE You have been prescribed GenvoyaÂŽ to treat HIV-infection. This booklet is designed to support you in using Genvoya and to inform you on how it works.

This guide is based on the package leaflet supplied with Genvoya1 and should not be used as a replacement.

The package leaflet contains the officially approved text.

Your doctor, HIV-consulent and pharmacist are the initial contacts for information. If you have any questions after reading this booklet, please remember to contact one of them.

Š Gilead Sciences Netherlands BV This text was composed in 2017 with reference to the official package leaflet. No information contained in this document should be disclosed to others without written authorisation of Gilead SciencesNetherlands BV, Claude Debussylaan 22, 1082 MD Amsterdam.

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GETTING STARTED WITH GENVOYA WHAT IS HIV?

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WHAT IS GENVOYA?

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BE CAREFUL

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OTHER MEDICINES AND GENVOYA

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HOW DOES GENVOYA WORK?

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OPTIMAL USE

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ONE TABLET EVERY DAY

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KEEP TRACK

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MISSED A DOSE?

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POSSIBLE SIDE EFFECTS

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PREGNANCY AND BREAST-FEEDING

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CO-INFECTION 24

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HEALTHY LIFESTYLE

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SWITCHING FROM STRIBILD TO GENVOYA

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SWITCHING FROM TRUVADA TO GENVOYA

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SWITCHING FROM ATRIPLA TO GENVOYA

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SEVEN IMPORTANT TIPS

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FREQUENTLY ASKED QUESTIONS

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05

WHAT IS HIV?

WHAT IS GENVOYA?

The human immunodeficiency virus (HIV) infects specific

HIV-infection can be treated with Genvoya

cells of the immune system, known as CD4 cells. Prolonged

Genvoya causes the viral load to drop, through the

infection weakens the immune system. The virus continues

inhibition of viral replication. As a result, virus replication

to create multiple copies of itself, causing your CD4 cell

is reduced and many of the remaining virus particles are

count to reduce. As a result, your body is less capable of

eliminated from the body.

fighting infections and illnesses.

Genvoya contains a combination of active substances, At the time these infections and illnesses occur, there is

in one tablet. Also, Genvoya can be taken with certain

the risk of Acquired Immune Deficiency Syndrome (AIDS).

medication for other diseases, however not with all

To prevent AIDS, it is important to treat HIV in time with

medications (see page 9: ‘Other medicines and Genvoya’).

the proper treatment.2 This allows the immune system to

This treatment is for use by adults and adolescents aged

continue to do its job. The primary goal of HIV-treatment is

12 years and older, with a body weight of at least 35 kg.

level (undetectable viral load). As a result, the number of

ACTIVE SUBSTANCES IN GENVOYA:

CD4 cells will remain sufficient, i.e. the immune system is

• elvitegravir

• cobicistat

more capable to fight off infections and diseases.

• emtricitabine

• tenofovir alafenamide

HIV can be transmitted from an infected person to an

Elvitegravir is an antiretroviral medicine known as an integrase

uninfected person through body fluids, such as genital

inhibitor, cobicistat is a booster (pharmacokinetic enhancer)

fluids (semen, pre-seminal fluid, rectal fluids and vaginal

of the effects of elvitegravir, without anti-HIV activity,

fluids) during unprotected sexual contact (vaginal, anal and

emtricitabine and tenofovir alafenamide are antiretroviral

oral), donor sperm, donor tissue, blood products, blood

medicines. Each tablet contains 150 mg elvitegravir,

from contaminated needles, or mother to child during

150 mg cobicistat, 200 mg emtricitabine and 10 mg

pregnancy, childbirth and breast-feeding.

tenofovir alafenamide.

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2,3

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INFORMATION FOR PATIENTS

to reduce the amount of viral particles to an undetectable

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BE CAREFUL What do you need to know before taking Genvoya?

Restrictions apply to all medications, including Genvoya.

OTHER MEDICINES AND GENVOYA Are you taking any other medicines?

Genvoya may interact with other medicines.

DO NOT TAKE GENVOYA IF: • you are allergic to elvitegravir, cobicistat,

DO NOT TAKE GENVOYA AND TELL YOUR DOCTOR

emtricitabine, tenofovir alafenamide or any of the

IMMEDIATELY IF YOU ARE TAKING:

other ingredients of this medicine (see package

• medicines used in treating hepatitis B infection:

leaflet for a full list).

tenofovir disoproxil, lamivudine, adefovir dipivoxil • alfuzosin, used to treat an enlarged prostate gland

BE CAREFUL IF: • you have liver problems or a history of liver disease, including hepatitis.

• you are intolerant to lactose.

• amiodarone, quinidine, used to correct irregular heartbeats • carbamazepine, phenobarbital, phenytoin, used to prevent seizures

For additional information, please refer to the package leaflet. If any of these conditions apply to you, tell your doctor, even if he or she has not asked.

other infections • dihydroergotamine, ergometrine, ergotamine, used to treat migraine headache • cisapride, used to relieve certain stomach problems • St. John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or products that contain it

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INFORMATION FOR PATIENTS

• rifampicin, used to prevent and treat tuberculosis and

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• lovastatin, simvastatin, used to lower blood cholesterol

• immunosuppressants, used to control your body’s

• pimozide, used to treat abnormal thoughts or feelings

immune response after a transplant, such as:

• sildenafil, when used to treat pulmonary arterial

ciclosporin, sirolimus and tacrolimus

hypertension • orally administered midazolam, triazolam, used to help you sleep and/or relieve anxiety

• corticosteroids including: betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone • medicines used to treat diabetes: metformin • contraceptive pill, used to prevent pregnancy

• antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole • antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin • antiviral medicines used to treat hepatitis C: telaprevir and boceprevir • antidepressants, used to treat depression: medicines containing trazodone or escitalopram • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam

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• erectile dysfunction medicines, used to treat impotence, such as: sildenafil, tadalafil and vardenafil • heart medicines, such as: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil • medicines used to treat pulmonary arterial hypertension: bosentan and tadalafil • anticoagulants, used to thin the blood, such as: warfarin and dabigatran

INFORMATION FOR PATIENTS

TALK TO YOUR DOCTOR IF YOU ARE TAKING:

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• bronchodilators, used to treat asthma and other lung-related problems: salmeterol • cholesterol lowering medicines, such as: atorvastatin and pitavastatin • medicines used to treat gout: colchicine

HOW DOES GENVOYA WORK? How do you know if your treatment is working well?

In order to determine whether Genvoya works for you, blood is taken for examination. Test results can show whether the amount of virus (viral load) has decreased and the amount of CD4 cells has increased.

If you are taking an antacid or a multivitamin supplement, take it at least 4 hours before or at least 4 hours

You can still pass on HIV when taking this medicine,

after Genvoya.

although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed

Tell your doctor or pharmacist if you are taking, have

This medicine is not a cure for HIV infection. While

recently taken or might take any other medicines. If you are

taking Genvoya you may still develop infections or

considering stopping your treatment with Genvoya, contact

other illnesses associated with HIV infection.

your doctor to discuss the possibilities. Do not stop your treatment without contacting your doctor.

For full details about using Genvoya please refer to the package leaflet.

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INFORMATION FOR PATIENTS

to avoid infecting other people.

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OPTIMAL USE Intake of Genvoya

If the virus develops resistance, the active substances in

When you take Genvoya, the active substances enter your

Genvoya are no longer able to effectively inhibit the virus.

blood stream through the digestive tract. Genvoya then

If you consider stopping your treatment with Genvoya,

disappears from your blood and you need to take another

talk to your doctor or nurse. They can assist you in

dose. The recommended dose is one tablet every day.

finding the proper solution.

When you miss a dose, less Genvoya is present in your

Tell your doctor or pharmacist if you are taking, have

body to inhibit viral replication. This has two serious

recently taken or might take any other medicines. If you

disadvantages. First, because there is less Genvoya, the

are considering stopping your treatment with Genvoya,

virus is better able to multiply and attack the immune

contact your doctor to discuss the possibilities.

system. Second, the virus may change its shape while

INFORMATION FOR PATIENTS

multiplying, and the new virus may become resistant.

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ONE TABLET EVERY DAY

KEEP TRACK

What to be aware of when taking Genvoya?

Make sure you keep track

Once you have started Genvoya, two things are of

At times you may not remember if you have taken your daily

importance. First, the level of Genvoya in your body must

dose. If this problem occurs frequently, make sure you set

be maintained. Second, you should immediately talk to

up a monitoring system. For example, use a pill organiser,

your doctor if you notice any side effects.

labelled with the days of the week, in which you can store your daily dose. There are also daily pill boxes that you attach

The recommended dose is one tablet every day, with

as a keychain to allow you quick access to spare tablets.

a dose is minimized. However, the absorption of Genvoya

Have spare tablets handy

is disrupted if you vomit less than 1 hour after the intake,

Life is full of surprises, and it may happen that you are

or if you are suffering from severe diarrhoea. On page

somewhere else than expected at your scheduled time of

18 ‘Missed a dose?’ you can read what to do in these

intake. Therefore it is important to make sure you always

situations.

have some extra tablets with you.

Choose a convenient time of intake

If necessary, set an alarm clock

For instance, when you take Genvoya in the evening

You could set an alarm clock on your mobile phone to

during dinner, it becomes a habit and the risk of missing

remind you to take Genvoya. There are also pill organisers

a dose is minimized.4

with a built-in alert system.

Genvoya during your holiday During holidays, daily routines are often broken, especially if you are travelling across time zones. If you are travelling

INFORMATION FOR PATIENTS

food, at about the same time. Thereby, the risk of missing

to a different time zone, please consult your doctor about the best dosing schedule. It is best to maintain the 24 hour interval between doses.

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MISSED A DOSE? Missed a dose?

When your supply of Genvoya starts to run low, go to

It is normal to occasionally forget something. It may

your doctor for a new prescription. This is very important

happen that, despite all good intentions and precautions

because the amount of virus may start to increase if the

you still forget to take your medication. Discuss in advance

medicine is stopped for even a short time. The disease

with your doctor or HIV-consulent what to do in

may then become harder to treat. Do not take a double

this situation.

dose to compensate for the missed tablet.

In general, the following applies:

If you vomit less than 1 hour after taking Genvoya, take another tablet with food. If you are suffering from severe

Did you miss a dose of Genvoya? ... If you notice within 18 hours

... If you notice after 18 hours or more

take the tablet as soon as possible (with food)

skip the missed dose

insufficiently absorbed by the body. Therefore, contact your doctor if you are suffering from severe diarrhoea for

Do not stop taking Genvoya without talking to your doctor.

When your supply of Genvoya starts to run low, refill your prescription at your pharmacist.

INFORMATION FOR PATIENTS

more than two days.

WAIT AND TAKE THE NEXT DOSE AT YOUR USUAL TIME (WITH FOOD).

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diarrhoea, there is a risk that Genvoya is not absorbed or

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POSSIBLE SIDE EFFECTS Like all medicines, Genvoya can cause side effects,

Common side effects

although this differs between individuals. When treating

(may affect up to 1 in 10 people)

HIV infection, it is not always possible to tell whether

• abnormal dreams

some of the unwanted effects are caused by Genvoya,

• headache

other medicines that you are taking at the same time, or

• dizziness

by the HIV disease itself.

• diarrhoea • vomiting

Possible serious side effects

• stomach pain

• Any signs of inflammation or infection.

• wind (flatulence)

• Autoimmune disorders. Look out for any symptoms of

• rash

infection or other symptoms such as: muscle weakness,

• tiredness (fatigue)

up towards the trunk of the body. palpitations, tremor

Uncommon side effects

or hyperactivity.

(may affect up to 1 in 100 people) • low red blood cell count (anaemia)

If you notice the side effects described above, tell your

• depression

doctor immediately.

• problems with digestion resulting in discomfort after

Very common side effects

• swelling of the face, lips, tongue or throat (angioedema)

(may affect more than 1 in 10 people)

• itching (pruritus)

meals (dyspepsia)

• feeling sick (nausea) If any of the side effects get serious tell your doctor.

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INFORMATION FOR PATIENTS

weakness beginning in the hands and feet and moving

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Other effects that may be seen during HIV treatment

PREGNANCY AND BREAST-FEEDING

During HIV therapy there may be an increase in weight

You cannot use Genvoya during pregnancy, unless this is

and in levels of blood lipids and glucose. This is partly

specifically discussed with your doctor.

linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.

Contraception

Your doctor will test for these changes.

Women are advised to use effective contraception while taking Genvoya to avoid pregnancy.

Some patients may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of

Pregnancy

blood supply to the bone). Signs of osteonecrosis are:

If you are pregnant, think you may be pregnant or are

• joint stiffness;

planning to have a baby, ask your doctor for advice

• joint aches and pains (especially of the hip, knee,

before you start taking this medicine.

and shoulder); Breast-feeding Do not breast-feed during treatment with Genvoya.

Reporting of side effects

Active substances in this medicines are excreted in

If you get any side effects, talk to your doctor or

breast milk.

pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects

It is also recommended that you do not breast-feed to

directly via the national reporting system:

avoid passing the virus to the baby through breast milk.

Nederlandse Bijwerkingen Centrum Lareb Website: www.lareb.nl

INFORMATION FOR PATIENTS

• difficulty with movement.

By reporting side effects you can help provide more information on the safety of this medicine.

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CO-INFECTION

HEALTHY LIFESTYLE

Hepatitis

Tips for a healthy lifestyle

Patients with liver disease, including chronic hepatitis B or

The HIV-virus suppresses your immune system. Although

C, who are treated with antiretrovirals, have a higher risk

Genvoya reduces this suppression, it is still important to not

of severe and potentially fatal liver complications. If you

impose an extra burden on your immune system, and adopt

are infected with the hepatitis B-virus, your doctor should

a healthy lifestyle. Live healthy, eat healthy, sleep well.

carefully consider the best treatment regimen for you.

HEALTHY LIFESTYLE If you are infected with the hepatitis B-virus and stop taking Genvoya, you may put yourself at risk of severe acute liver

• perform physical activity (e.g. walking, playing sports, cycling) on regular basis

complications. It is therefore important to not stop taking

• do relaxation exercises (e.g. yoga)

Genvoya without talking to your doctor.

• eat fruits and vegetables • quit smoking

SLEEP WELL • maintain a regular sleep pattern • relax before going to bed (e.g. reading, a hot bath) • do not work out before going to bed • do not drink coffee or eat chocolate in the evening • do not eat a large meal before going to bed • ensure a dark, quiet bedroom (use earplugs if

INFORMATION FOR PATIENTS

• limit or avoid the use of alcohol and recreational drugs

necessary) • do not oversleep

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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM STRIBILD TO GENVOYA.

SWITCHING FROM STRIBILD TO GENVOYA What is the difference between Stribild and Genvoya?

Active substances

Stribild contains four active substances, elvitegravir,

Elvitegravir is an antiretroviral medicine known as

cobicistat, emtricitabine and tenofovir disoproxil

integrase inhibitor.

(as fumarate).

Cobicistat is a booster (pharmacokinetic enhancer) of the Genvoya also contains four substances, elvitegravir,

effects of elvitegravir.

fumarate. Of the four substances, three are the same

Emtricitabine is an antiretroviral medicine, known as

as in Stribild. In Genvoya, the active substance tenofovir

nucleoside reverse transcriptase inhibitor (NRTI).

disoproxil fumarate is replaced by tenofovir alafenamide (as fumarate). In the following chart you will find

Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral

an overview.

medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir in the body.

STRIBILD®

GENVOYA®

• Elvitegravir 150 mg

• Elvitegravir 150 mg

• Cobicistat 150 mg

• Cobicistat 150 mg

• Emtricitabine 200 mg

• Emtricitabine 200 mg

• Tenofovir disoproxil (as fumarate) 245 mg

• Tenofovir alafenamide (as fumarate) 10 mg

Tenofovir is the active substance.

Tenofovir alafenamide (as fumarate, TAF) is an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir in the body. Tenofovir is the active substance. TAF is converted to tenofovir in a different way compared to

SWITCHING FROM STRIBILD TO GENVOYA

cobicistat, emtricitabine and tenofovir alafenamide

TDF. This means with a lower dose you get the same effect on the virus.

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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM STRIBILD TO GENVOYA.

WHAT REMAINS THE SAME WHEN YOU SWITCH FROM STRIBILD TO GENVOYA The number of tablets you take each day

Booster

You take one tablet each day.

Both Stribild and Genvoya contain the active substance cobicistat. This is a booster (pharmacokinetic ‘booster’) from

Intake with food

the effects of elvitegravir. By using boosters, your doctor

You should take Genvoya with food.

and pharmacist will be on extra alert for possible changes (‘interactions’) between the booster and other medication.

Your medicines will be supplied by your regular pharmacy.

Your pharmacy will be able to supply medication for at least three months.

Missed a dose?

If you do miss a dose and notice within 18 hours of the time you usually take Genvoya, you should take the tablet as soon as possible. However, if you notice 18 hours or more after the time you usually take Genvoya, then do not take the missed dose. Wait and take the next dose, with food, at your usual time.

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SWITCHING FROM STRIBILD TO GENVOYA

Pharmacy

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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM STRIBILD TO GENVOYA.

THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO GENVOYA.

WHAT CAN CHANGE WHEN YOU SWITCH FROM STRIBILD TO GENVOYA

SWITCHING FROM TRUVADA AND BOOSTED PROTEASE INHIBITOR TO GENVOYA

Active substances

What is the difference between Truvada and Genvoya?

Both Stribild and Genvoya contain four active substances.

Truvada contains two substances, emtricitabine and

In Genvoya, the active substance tenofovir disoproxil

tenofovir disoproxil (as fumarate). In addition to Truvada,

(as fumarate) is replaced with tenofovir alafenamide

you take a protease inhibitor and a booster. This booster

(as fumarate). You doctor can tell you more about this.

can be a component of the third medication or prescribed as a separate tablet.

Kidney monitoring tests When you were taking Stribild, your doctor possibly

Genvoya contains four substances, elvitegravir, cobicistat,

ordered blood tests during treatment to monitor your

emtricitabine and tenofovir alafenamide fumarate. In the

kidneys. When you take Genvoya, it is not necessary to

following chart you will find an overview.

decide whether or not to continue kidney monitoring.

Possible side effects

PROTEASE INHIBITOR*

GENVOYA®

• Protease inhibitor

• Elvitegravir 150 mg

+ BOOSTER

All medicines can cause side effects, and switching to

• Booster

a new HIV-treatment may also cause new side effects.

+ TRUVADA®

Some of the possible side effects of Genvoya are

• Emtricitabine 200 mg • Tenofovir disoproxil (as fumarate) 245 mg

described in this booklet. Discuss with your doctor or HIV-consulent what differences you can expect between your current treatment and Genvoya.

• Cobicistat 150 mg • Emtricitabine 200 mg • Tenofovir alafenamide (as fumarate) 10 mg

INFORMATION FOR PATIENTS

assess your kidneys on a regular basis. Your doctor will

* The booster can be part of the same tablet as the protease inhibitor, or prescribed as a separate tablet.

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Active substances

Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral

A protease inhibitor is a class within the HIV-inhibitors.

medicine known as a nucleotide reverse transcriptase

Commonly used protease inhibitors are atazanavir,

inhibitor (NtRTI). It is converted to tenofovir in the body.

darunavir and lopinavir.

Tenofovir is the active substance.

Often, a protease inhibitor works together with a

Tenofovir alafenamide (as fumarate, TAF) is an

pharmakinetic booster also known as ‘booster’. The most

antiretroviral medicine known as a nucleotide reverse

used boosters are cobicistat and ritonavir. The booster

transcriptase inhibitor (NtRTI). It is converted to tenofovir

can be part of the same tablet as the protease inhibitor,

in the body. Tenofovir is the active substance. TAF is

or prescribed as a separate tablet.

converted to tenofovir in a diff erent way compared to

Elvitegravir is an antiretroviral medicine known as integrase inhibitor.

Cobicistat is a booster (pharmacokinetic enhancer) of the effects of elvitegravir.

Emtricitabine is an antiretroviral medicine, known as nucleoside reverse transcriptase inhibitor (NRTI).

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effect on the virus.

SWITCHING FROM TRUVADA TO GENVOYA

TDF. This means with a lower dose you get the same

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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO GENVOYA.

WHAT REMAINS THE SAME WHEN YOU SWITCH FROM TRUVADA TO GENVOYA

WHAT CAN CHANGE WHEN YOU SWITCH FROM TRUVADA TO GENVOYA

A fixed time of intake

One tablet a day

You have to take your HIV-medication at a fixed time

You take one tablet each day.

of the day.

As you can see on page 31, Genvoya contains other active

You have to take Genvoya with food. It is not necessary

substances than Truvada. These active substances may

to take the tablet with a meal.

have different long-term effects. Your doctor or HIV-consulent can tell you more about the long-term

Pharmacy

effects of Genvoya.

Your medicines can be picked up at your regular pharmacy. Your pharmacy will be able to supply

Side effects

medication for at least three months.

All medicines can cause side effects, and switching to a new HIV-treatment may also cause new side effects.

Booster

The possible side effects of Genvoya are described in

Both your current treatment combination and Genvoya

this brochure. Discuss with your doctor or HIV-consulant

contain a pharmacokinetic booster. By using boosters,

what differences you can expect between your current

your doctor and pharmacist will be on extra alert for

treatment and Genvoya.

possible changes (‘interactions’) between the booster

SWITCHING FROM TRUVADA TO GENVOYA

Long-term effects Intake with food

and other medication.

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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO GENVOYA.

THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM ATRIPLA TO GENVOYA.

Kidney monitoring

SWITCHING FROM ATRIPLA TO GENVOYA

Before your treatment with Truvada started, your doctor possibly assessed your kidney function. Your doctor also possibly ordered blood tests during treatment to monitor

What is the difference between Atripla and Genvoya?

your kidneys. If you switch from Truvada to Genvoya, it is

Atripla contains three active substances, efavirenz,

not necessary to assess your kidneys on a regular basis.

emtricitabine and tenofovir disoproxil (as fumarate).

It is up to your doctor, whether he continues these blood tests.

Genvoya contains four substances, elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (as fumarate).

Missed a dose?

In the following chart you will find an overview.

time you usually take Genvoya, you should take the tablet as soon as possible. Then take the next dose as usual.

ATRIPLA®

GENVOYA®

However, if you notice 18 hours or more after the time you

• Efavirenz 600 mg

• Elvitegravir 150 mg

usually take Genvoya, then do not take the missed dose.

• Cobicistat 150 mg

Wait and take the next dose at your usual time.

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• Emtricitabine 200 mg

• Emtricitabine 200 mg

•T enofovir disoproxil (as fumarate) 245 mg

• Tenofovir alafenamide (as fumarate) 10 mg

SWITCHING FROM ATRIPLA TO GENVOYA

If you do miss a dose and notice within 18 hours of the

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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM ATRIPLA TO GENVOYA.

Active substances Efavirenz is an antiretroviral medicine known as nonnucleoside reverse transcriptase inhibitor (NNRTI).

Elvitegravir is an antiretroviral medicine known as

WHAT REMAINS THE SAME WHEN YOU SWITCH FROM ATRIPLA TO GENVOYA

integrase inhibitor.

The number of tablets you take each day Cobicistat is a booster (pharmacokinetic enhancer) of the

You take one tablet each day.

effects of elvitegravir.

Pharmacy Emtricitabine is an antiretroviral medicine, known as

Your medicines can be picked up at your regular

nucleoside reverse transcriptase inhibitor (NRTI).

pharmacy. Your pharmacy will be able to supply

Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral medicine known as a nucleotide reverse

A fixed time of intake

transcriptase inhibitor (NtRTI). It is converted to tenofovir

You take your HIV-medication at a fixed time of the day.

in the body. Tenofovir is the active substance.

With Genovya this will remain the same.

Tenofovir alafenamide (as fumarate, TAF) is an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir in the body. Tenofovir is the active substance. TAF is converted to tenofovir in a different way compared to TDF. This means with a lower dose you get the same

SWITCHING FROM ATRIPLA TO GENVOYA

medication for at least three months.

effect on the virus.

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WHAT CAN CHANGE WHEN YOU SWITCH FROM ATRIPLA TO GENVOYA Long-term effects

Intake with food

As you can see on page 37, Genvoya contains other

You should take Genvoya with food. It is not necessary

active substances than Atripla. These active substances

to take the tablet with a meal.

may have different long-term effects. Your doctor or HIV-consulent can tell you more about the long-term

Booster

effects of Genvoya.

Genvoya contains the active substance cobicistat. effects of elvitegravir. By using boosters, your doctor

All medicines can cause side effects, and switching to a

and pharmacist will be on extra alert for possible changes

new HIV-treatment may mean you experience side effects

(‘interactions’) between the booster and

that you didn’t experience when taking your previous

other medication.

medicine. Some of the possible side effects of Genvoya are described in this booklet. Discuss with your doctor

Missed a dose?

what differences you might expect between your current

If you do miss a dose and notice within 18 hours of the

treatment and Genvoya.

time you usually take Genvoya, you should take the tablet as soon as possible. Then take the next dose as usual.

Kidney monitoring tests

However, if you notice 18 hours or more after the time you

When you were taking Atripla, your doctor possibly

usually take Genvoya, then do not take the missed dose.

ordered blood tests during treatment to monitor your

Wait and take the next dose at your usual time.

kidneys. When you take Genvoya, it is not necessary to

SWITCHING FROM ATRIPLA TO GENVOYA

This is a booster (pharmacokinetic ‘booster’) from the Possible side effects

assess your kidneys on a regular basis. It is up to your doctor, whether he continues these blood tests.

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SEVEN IMPORTANT TIPS 1. Take one tablet at about the same time every day.

6. If you are taking an antacid or a multivitamin

This makes it easier to remember your daily intake

supplement, take it at least 4 hours before or at least

of Genvoya. For example, take Genvoya every day

4 hours after Genvoya.

with a particular meal.

7. Make sure you always have a supply of Genvoya at 2. Take one tablet every day with food (breakfast, lunch, dinner or snack).

home. Remember to request for a prescription refill in time. If you leave home or are travelling, always take Genvoya with you.

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

4. If you vomit less than 1 hour after taking Genvoya, take another tablet. When in doubt, always contact your doctor or HIV-consulent.

5. It is important not to miss a dose of Genvoya. If you do miss a dose: • If you notice within 18 hours of the time you usually take Genvoya, you must take the tablet with food as soon as possible. Then take the next dose as usual.

• If you notice 18 hours or more after the time you usually take Genvoya, then do not take the missed dose. Wait and take the next dose, with food, at your

IMPORTANT TIPS

usual time.

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FREQUENTLY ASKED QUESTIONS Genvoya reduces the amount of viral particles by

Genvoya is an anti-human immunodeficiency virus (HIV)

inhibiting the replication of the virus. The treatment is

medicine. This means that this medicine contributes to

successful if the amount of viral particles (viral load) in

the treatment of HIV-infection. It helps prevent the HIV

your blood is reduced to an undetectable level. Then, the

from replicating and creating copies of itself, and slows

number of CD4 cells will increase, i.e. the immune system

down the progression of the disease.

recovers from its weakened state.

What does my medicine look like?

What are the ingredients of Genvoya?

Genvoya film-coated tablets are green, capsule-shaped

Genvoya contains four active substances: elvitegravir,

tablets, debossed on one side with “GSI” and the number

cobicistat, emtricitabine and tenofovir alafenamide. These

“510” on the other side of the tablet. Genvoya comes in

are antiretroviral medicines. Each tablet contains 150 mg

bottles of 30 tablets, and a silica gel desiccant (that must

elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and

be kept in the bottle to help protect your tablets).

10 mg tenofovir alafenamide.

The silica gel desiccant is packaged in a separate sachet or canister and should not be swallowed.

Does this medicine cure HIV? No, this medicine is not a cure for HIV-infection. To

How does this medicine work?

control your HIVinfection and infections or other illnesses

HIV infects specific cells of the immune system and

associated with HIV-infection, you should always take this

therefore weakens the immune system. The HIV-virus

medication exactly as your doctor has prescribed it.

creates multiple copies of itself that continue to weaken the immune system. As a result, your body is less capable

FREQUENTLY ASKED QUESTIONS

Why have I been prescribed this medicine?

of fighting infections and illnesses.1

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Who can prescribe Genvoya?

How do I take my medicine?

Genvoya is a prescription medicine that can only be

Always take this medication exactly as your doctor has

prescribed by a healthcare professional.

prescribed it. Check with your doctor or pharmacist if

You should only take this medication if it has been

you are not sure. The recommended daily intake is one

prescribed by your doctor.

tablet every day with food. Do not chew, crush or split

the tablet.

When should I not take this medication?

If you are allergic to emtricitabine, tenofovir alafenamide

How should I store this medicine?

or any of the other ingredients of this medicine (you can

Store Genvoya in its original packaging to protect from

find all ingredients in the package leaflet) or if you use

moisture. Keep the bottle tightly closed. Keep the

any of the other medicines mentioned on page 9 in the

tablets out of sight and reach of children. Do not use this

section “Other medicines and Genvoya”.

medication after the expiry date. Ask your pharmacist

HIV to other people?

What do I need to tell my doctor before I start taking

You can still transmit HIV when taking this medicines,

this medicine?

although the risk is lowered by effective antiretroviral

Tell your doctor or pharmacist if you are taking, have

therapy. Discuss with your doctor the precautions needed

recently taken or are going to take any other medicines.

to avoid infecting other people. This medicine is not a

Tell your doctor if you are allergic to any of the

cure for HIV-infection. While taking Genvoya you may

ingredients (see package leaflet for a full list) or if you

still develop infections or other illnesses associated with

are pregnant, are likely to become pregnant or if you

HIV-infection.

are breastfeeding. Also tell your doctor if you have liver

FREQUENTLY ASKED QUESTIONS

how to throw away medicines you no longer use.

Does my medicine reduce the risk of me transmitting

problems, or a history of liver disease, including hepatitis.

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Can this medicine cause side effects?

If you notice 18 hours or more after the time you usually

As with all medicines, you may get side effects. On page

take Genvoya, then do not take the missed dose. Wait

20 you will find possible side effects. For a full list of side

and take the next dose at your usual time. If you vomit

effects, please refer to the package leaflet that is supplied

less than 1 hour after taking your medication, take

with your medication. If you notice any side effects, talk

another tablet. Do not stop taking Genvoya without first

to your doctor or pharmacist. This includes any possible

talking to your doctor.

side effects not listed in the package leaflet. breast-feeding?

taking Genvoya?

If you are pregnant, think you may be pregnant or are

Yes. You should look out for symptoms of inflammation,

planning to have a baby, ask your doctor for advice

infection or autoimmune disorders, such as muscle

before taking this medicine. Use effective contraception

weakness, palpitations, tremors or hyperactivity. If you

while taking Genvoya to avoid getting pregnant.

notice one of these symptoms, please tell your doctor immediately. For more information, please refer to the

Do not breast-feed during treatment with this medicine.

package leaflet.

This is because some of the active substances in this medicine are excreted in breast milk.

What do I do if I miss a dose of my medicine?

It is important to not miss a dose of Genvoya. If you

It is also recommended that you do not breast-feed

notice within 18 hours of the time you usually take your

to avoid transmitting the virus to the baby through

medication, take the tablet as soon as you remember.

breast milk.

Take the tablet with food and then take the next dose

FREQUENTLY ASKED QUESTIONS

Should I take this medicine if I am pregnant or if I am Is it possible to experience serious side effects while

at the usual time.

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NOTES

NOTES

NOTES

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TAF/NL/16-01/NPM/1035(1)a Date of preparation: November 2017

REFERENCES 1. Package leaflet Genvoya www.cbg-meb.nl/geneesmiddeleninformatiebank 2. Rijksinstituut voor Volksgezondheid en Milieu. Ministerie van Volksgezondheid, Welzijn en Sport. LCI guideline HIV infection. Verkregen op 11 februari 2016, van https://lci.rivm.nl/richtlijnen/hivinfectie 3. Living with HIV and AIDS, www.nhs.uk/Conditions/HIV/Pages/living-with.aspx.

4. Compliance, www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/ Stappenplannen/Infectieziekten/VSI/VSI_Hiv