Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. How to report side effects is explained at the end of section 4.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Genvoya is and what it is used for
2. What you need to know before taking Genvoya
3. How to take Genvoya
4. Possible side effects
5. How to store Genvoya
6. Contents of the pack and other information

If Genvoya has been prescribed for your child, please note that all information in this leaflet is directed to your child (in this case, when you read “you”, replace it with “your child”).

1. What Genvoya is and what it is used for

Genvoya contains four active substances:

• elvitegravir, an antiretroviral medicine known as an integrase inhibitor
• cobicistat, a booster (pharmacokinetic enhancer) of elvitegravir's effects
• emtricitabine, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI)

Genvoya is a single tablet for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults, adolescents, and children aged 6 years and older who weigh at least 25 kg.

Genvoya reduces the amount of HIV in the body. This improves the immune system and reduces the risk of developing HIV-related illnesses.

2. What you need to know before taking Genvoya

Do not take Genvoya:

• If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, or to any of the other components of this medicine (listed in section 6 of this leaflet).

• If you are taking any of the following medicines:

• alfuzosin (used to treat enlarged prostate)

• dabigatran (used to prevent and treat blood clots)

• amiodarone, quinidine (used to correct irregular heartbeats)

• carbamazepine, phenobarbital, phenytoin (used to prevent seizures)

• rifampicin (used to prevent and treat tuberculosis and other infections)

• dihydroergotamine, ergometrine, ergotamine (used to treat migraines)

• cisapride (used to relieve certain stomach problems)

• St. John’s wort (Hypericum perforatum, a herbal medicine used for depression and anxiety) or products containing it

• lovastatin, simvastatin (used to reduce blood cholesterol)

• pimozide, lurasidone (used to treat abnormal thoughts or feelings)

• sildenafil (when used to treat pulmonary arterial hypertension, a lung disease that makes breathing difficult)

• midazolam taken orally**, triazolam** (used to help sleep and/or relieve anxiety)

? If you are in any of these situations, do not take Genvoya and consult your doctor immediately.

Warnings and precautions

You must remain under your doctor’s supervision while taking Genvoya.

While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk. Ask your doctor what precautions are necessary to avoid infecting other people. This medicine is not a cure for HIV infection. While you are taking Genvoya, you may still develop infections or other illnesses associated with HIV infection.

Talk to your doctor before starting Genvoya:

• If you have liver problems or a history of liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals have a higher risk of serious and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B infection, liver problems may worsen after stopping Genvoya. It is important that you do not stop taking Genvoya without first talking to your doctor: see section 3, Do not stop treatment with Genvoya.

• If you have lactose intolerance (see Genvoya contains lactose later in this section).

While taking Genvoya

Once you start taking Genvoya, be alert for:

• Signs of inflammation or infection
• Joint pain, stiffness, or bone problems

? If you notice any of these symptoms, inform your doctor immediately. For more information, see section 4, Possible side effects.

Children and adolescents

Do not give this medicine to children aged 5 years or younger, or who weigh less than 25 kg regardless of age. The use of Genvoya has not yet been studied in children aged 5 years or younger.

Other medicines and Genvoya

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Genvoya can interact with other medicines. As a result, blood levels of Genvoya or other medicines may be affected. This could prevent your medicines from working properly or worsen their possible side effects. In some cases, your doctor may need to adjust the dose or monitor your blood levels.

Medicines that must never be taken with Genvoya:

• alfuzosin (used to treat enlarged prostate)
• amiodarone, quinidine (used to correct irregular heartbeats)
• carbamazepine, phenobarbital, phenytoin (used to prevent seizures)
• dabigatran (used to prevent and treat blood clots)
• rifampicin (used to prevent and treat tuberculosis and other infections)
• dihydroergotamine, ergometrine, ergotamine (used to treat migraines)
• cisapride (used to relieve certain stomach problems)
• St. John’s wort (Hypericum perforatum, a herbal medicine used for depression and anxiety) or products containing it
• lovastatin, simvastatin (used to reduce blood cholesterol)
• pimozide, lurasidone (used to treat abnormal thoughts or feelings)
• sildenafil (when used to treat pulmonary arterial hypertension, a lung disease that makes breathing difficult)
• midazolam taken orally**, triazolam** (used to help sleep and/or relieve anxiety)

? If you are taking any of these medicines, do not take Genvoya and inform your doctor immediately.

Medicines used to treat hepatitis B virus infection:

You must not take Genvoya with medicines containing:

• tenofovir alafenamide

• tenofovir disoproxil

• lamivudine

• adefovir dipivoxil

? Consult your doctor if you are taking any of these medicines.

Other types of medicines:

Talk to your doctor if you are taking:

• 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

• 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

• immunosuppressants, used to control the body’s immune response after transplantation, such as:

• cyclosporine, sirolimus and tacrolimus

• corticosteroids, including:

• betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.

These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory eye, joint and muscle conditions, and other inflammatory conditions. If alternatives cannot be used, they should only be used after clinical evaluation and with close monitoring by your doctor to assess corticosteroid-related side effects.

• medicines used to treat diabetes:

• metformin

• oral contraceptive pill, used to prevent pregnancy

• medicines for erectile dysfunction, 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 prevent and treat blood clots, such as:

• apixaban, edoxaban, rivaroxaban and warfarin

• bronchodilators, used to treat asthma and other lung-related problems:

• salmeterol

• medicines to lower cholesterol, such as:

• atorvastatin and pitavastatin

• medicines used to treat gout:

• colchicine

? Inform your doctor if you are taking these or any other medicines. Do not stop your treatment without consulting your doctor.

• antacids, used to treat heartburn or acid reflux (see also section 3, How to take Genvoya).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your doctor or pharmacist before using this medicine.

• Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant. Pregnant women should not take Genvoya. The amount of this medicine in the blood may decrease during pregnancy, which could cause it to stop working properly.
• Use an effective method of contraception while taking Genvoya.
• Do not breastfeed while being treated with Genvoya. This is because some of the active substances in this medicine pass into breast milk. It is recommended that you do not breastfeed to avoid transmitting the virus to your child through breast milk.

Driving and using machines

Genvoya may cause dizziness. If you feel dizzy during treatment with Genvoya, do not drive, ride a bicycle, or operate tools or machinery.

Genvoya contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

? If you are in any of these situations, consult your doctor before starting to take Genvoya.

3. How to take Genvoya

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: one tablet daily with food

Adolescents and children aged 6 years or older weighing at least 25 kg: one tablet daily with food

Do not chew or crush the tablet.

If you have difficulty swallowing the tablet whole, you may split it into two halves. Swallow both halves of the tablet one after the other to take the complete dose. Do not store the split tablet.

Always take the dose recommended by your doctor. This is to ensure that your medicine remains fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to do so.

Do not take antacids or multivitamins at the same time as Genvoya. If you are taking an antacid such as aluminium/magnesium hydroxide or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after taking Genvoya.

If you are on dialysis, take your daily dose of Genvoya after the dialysis session is completed.

If you take more Genvoya than you should

If you accidentally take more than the recommended dose of Genvoya, you may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible side effects).

Contact your doctor immediately or go to the nearest emergency department. Take the medicine container with you so you can easily describe what you have taken.

If you forget to take Genvoya

It is important not to miss a dose of Genvoya.

If you forget a dose:

• If you remember within 18 hours of the time you usually take Genvoya, take the tablet as soon as possible. Always take the tablet with food. Then take your next dose at the usual time.
• If you remember 18 hours or more after the time you usually take Genvoya, do not take the missed dose. Wait and take the next dose with food at the usual time.

If you vomit within 1 hour after taking Genvoya, take another tablet with food.

Do not stop treatment with Genvoya

Do not stop treatment with Genvoya without first talking to your doctor. Stopping Genvoya may seriously affect your response to future treatments. If Genvoya is stopped for any reason, consult your doctor before restarting Genvoya tablets.

When you notice that you are running low on Genvoya, contact your doctor or pharmacist to get more. This is very important, as the amount of virus may start to increase if the medicine is interrupted even for a short period of time. This could make the disease more difficult to treat.

If you have both HIV infection and hepatitis B, it is especially important not to stop treatment with Genvoya without first talking to your doctor. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may cause worsening of hepatitis, a condition that could be potentially fatal.

?Contact your doctor immediately about any new or unusual symptoms after stopping your treatment, particularly symptoms you associate with hepatitis B virus infection.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This is partly related to improved health, lifestyle factors, and, in the case of blood lipids, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. When treating HIV infection, it is not always possible to determine whether certain unwanted effects are due to Genvoya, to other medications being taken at the same time, or to the HIV disease itself.

Serious possible adverse effects: inform a doctor immediately

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders may also occur, in which the immune system attacks healthy tissues of the body, after starting treatment for HIV infection. Autoimmune disorders may occur many months after treatment has begun. Be alert for any signs of infection or other symptoms such as:

• muscle weakness

• weakness starting in the hands and feet and moving toward the trunk

• palpitations, tremor, or hyperactivity

?If you experience any of the adverse effects described above, inform your doctor immediately.

Very common adverse effects
(may affect more than 1 in 10 people)

• nausea (feeling sick)

Common adverse effects
(may affect up to 1 in 10 people)

• abnormal dreams
• headache
• dizziness
• diarrhea
• vomiting
• stomach pain
• gas (flatulence)
• rash
• tiredness (fatigue)

Uncommon adverse effects
(may affect up to 1 in 100 people)

• low red blood cell count (anemia)
• suicidal thoughts and suicide attempts (in patients who have previously had depression or mental health problems), depression
• digestive problems causing discomfort after meals (dyspepsia)
• swelling of the face, lips, tongue, or throat (angioedema)
• itching (pruritus)
• hives (urticaria)

?If you consider any of the adverse effects you are experiencing to be severe, inform your doctor.

Other effects that may occur during HIV treatment

The frequency of the following adverse effects is unknown (cannot be estimated from the available data).

• Bone problems. Some patients treated with combination antiretroviral medicines such as Genvoya may develop a bone disease called osteonecrosis (death of bone tissue due to loss of blood supply to the bone). Prolonged use of this type of medication, corticosteroid use, alcohol consumption, having a severely weakened immune system, and being overweight are among the many possible risk factors for developing this condition. Signs of osteonecrosis include:

• joint stiffness

• joint discomfort and pain (especially in the hip, knee, and shoulder)

• difficulty moving

?If you notice any of these symptoms, inform your doctor.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Genvoya

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

Do not use this medicine after the expiry date stated on the carton and bottle after {EXP}. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Genvoya

The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. Each Genvoya film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.

The other components are

Tablet core:

Lactose (as monohydrate), microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.

Film coating:

Polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), indigo carmine aluminium lake (E132), iron oxide yellow (E172).

Appearance of the product and contents of the pack

Genvoya film-coated tablets are green, capsule-shaped tablets, marked on one side with “GSI” and on the other with the number “510”. Genvoya is available in bottles of 30 tablets (with a silica gel desiccant which should remain in the bottle to help protect the tablets). The silica gel desiccant is contained in a separate sachet or container and must not be swallowed.

This medicine is available in packs containing 1 bottle of 30 film-coated tablets and in packs containing 90 tablets (3 bottles of 30) film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent revision of this leaflet: <{MM/YYYY}> <{month YYYY}>.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.