GENVOYA 150mg/150mg/200mg/10mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

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

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

If Genvoya has been prescribed to your child, please note that all the information in this leaflet that refers to ‘you’ also applies to your child (in this case, when you read ‘you’, replace it with ‘your child’).

1. What is Genvoya and what is it used for

Genvoya contains four active substances:

• elvitegravir, an antiretroviral medicine known as an integrase inhibitor
• cobicistat, a booster (pharmacokinetic enhancer) of the effects of elvitegravir
• 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 (HIV)-1 infectionin adults, adolescents and children from 6 years of age or older, weighing at least 25 kg.

Genvoya reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing diseases associated with HIV infection.

2. What you need to know before you take Genvoya

Do not take Genvoya:

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

• If you are taking any of these 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 that contain it
• lovastatin, simvastatin(used to lower cholesterol in the blood)
• pimozide, lurasidone(used to treat abnormal thoughts or feelings)
• sildenafil(when used to treat pulmonary arterial hypertension, a disease of the lung that makes it difficult to breathe)
• midazolamgiven by mouth, triazolam(used to help you 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 the supervision of your doctor while taking Genvoya.

While taking this medicine, you can still transmit HIV to others, even if effective antiviral treatment reduces the risk. Consult your doctor about the precautions needed to avoid infecting others. This medicine is not a cure for HIV infection. While you are taking Genvoya, you may still experience infections or other diseases associated with HIV infection.

Consult 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 life-threatening liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment 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 taking Genvoya.

• If you are lactose intolerant(see Genvoya contains lactoselater in this section).

While taking Genvoya

Once you start taking Genvoya, be aware of:

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

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

Children and adolescents

Do not give this medicine to childrenunder 6 years of age or weighing less than 25 kg, regardless of age. The use of Genvoya in children under 6 years of age has not been studied.

Other medicines and Genvoya

Tell your doctor or pharmacistif you are taking, have recently taken or might take any other medicines. Genvoya may interact with other medicines. As a result, the levels of Genvoya or other medicines in your blood may be affected. This may stop your medicines from working properly or may increase your risk of side effects. In some cases, your doctor may need to adjust the dose or monitor your blood levels.

Medicines that must not 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 that contain it
• lovastatin, simvastatin(used to lower cholesterol in the blood)
• pimozide, lurasidone(used to treat abnormal thoughts or feelings)
• sildenafil(when used to treat pulmonary arterial hypertension, a disease of the lung that makes it difficult to breathe)
• midazolamgiven by mouth, triazolam(used to help you sleep and/or relieve anxiety)

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

Medicines used to treat hepatitis B virus infection:

Do not take Genvoya with medicines that contain:

• tenofovir alafenamide

• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

?Consult your doctorif you are taking any of these medicines.

Other types of medicines:

Tell 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, that contain:

• rifabutin, clarithromycin and telithromycin

• antidepressants, used to treat depression:

• medicines that contain trazodone or escitalopram
• • sedatives and hypnotics, used to treat anxiety:
• buspirone, chlordiazepoxide, diazepam, estazolam, flurazepam, zolpidem and lorazepam

• immunosuppressants, used to control the body's immune response after a transplant, such as:

• ciclosporin, sirolimus and tacrolimus

• corticosteroidsincluding:

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

These medicines are used to treat allergies, asthma, inflammatory bowel disease, inflammatory eye, joint and muscle conditions, and other inflammatory conditions. If alternatives cannot be used, they should only be used after a clinical evaluation and with close monitoring by your doctor to assess the adverse effects of corticosteroids.

• medicines used to treat diabetes:

• metformin

• 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 problems:

• salmeterol

• cholesterol-lowering medicines, such as:

• atorvastatin and pitavastatin

• medicines used to treat gout:

• colchicine

?Tell your doctor if you are taking these or 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 Genvoya.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to have a baby.Women who are pregnant must not take Genvoya. The amount of this medicine in the blood may decrease during pregnancy, which may stop it from working properly.
• Use effective contraceptionwhile taking Genvoya.
• Do not breastfeed your child during treatment 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 prevent passing the virus to your child through breast milk.

Driving and using machines

Genvoya may cause dizziness. If you feel dizzy while taking Genvoya, do not drive, ride a bicycle or use tools or machines.

Genvoya contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Genvoya

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

Adults:one tablet once daily with food

Adolescents and children from 6 years of age or older, weighing at least 25 kg:one tablet once daily with food

Do not chew or crush the tablet.

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

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

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

If you are on dialysis, take your daily dose of Genvoya after dialysis 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 greater risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).

Consult your doctor immediately or go to the emergency department at your nearest hospital. Take the pack of tablets with you so that you can easily describe what you have taken.

If you forget to take Genvoya

It is important that you do not miss a dose of Genvoya.

If you miss a dose:

• If you notice within 18 hoursof the time you normally take Genvoya, you must take the tablet as soon as possible. Take the tablet with food. Then take the next dose as usual.
• If you notice 18 hours or moreafter the time you normally 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 of taking Genvoya, take another tablet with food.

Do not stop taking Genvoya

Do not stop taking Genvoya without talking to your doctor first.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 have almost finished a pack of Genvoya, go to your doctor or pharmacist to get more. This is very important, as the amount of virus may start to increase if the medicine is stopped, even for a short time. This may make the disease more difficult to treat.

If you have both HIV and hepatitis B, it is especially important not to stop your 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, it is not recommended to stop treatment as this may cause worsening of your hepatitis, which can be life-threatening.

?Talk to your doctor immediatelyabout new or unusual symptoms after stopping treatment, especially symptoms that you think may be related to hepatitis B virus infection.

If you have any further questions on 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 levels of glucose and lipids in the blood. This is partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce adverse effects, although not all people suffer from them. When treating HIV infection, it is not always possible to distinguish if some of the unwanted effects are due to Genvoya or to other medications being taken at the same time or to the disease caused by HIV itself.

Possible Serious 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 HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight infections that may have been present without obvious symptoms.

• There may also be autoimmune disorders,in which the immune system attacks the body's healthy tissues, after starting to take medications for HIV infection. Autoimmune disorders can occur many months after the start of treatment. Be aware of any symptoms of infection or other symptoms, such as:

• muscle weakness
• weakness that starts in the hands and feet and moves towards the trunk
• palpitations, tremors, or hyperactivity

If you notice any of the above adverse effects, inform your doctor immediately.

Very Common Adverse Effects

(may affect more than 1 in 10 people)

• nausea

Common Adverse Effects

(may affect up to 1 in 10 people)

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

Uncommon Adverse Effects

(may affect up to 1 in 100 people)

• low red blood cell count (anemia)
• suicidal thoughts and attempts (in patients who have had depression or mental health problems previously), depression
• digestive problems that cause 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 serious, inform your doctor.

Other Effects that May be Observed During HIV Treatment

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

• Bone problems.Some patients treated with combination antiretroviral medications like Genvoya may develop a bone disease called osteonecrosis(death of bone tissue due to loss of blood supply to the bone). Taking this type of medication for a long time, taking corticosteroids, drinking alcohol, having a very weakened immune system, and being overweight may be some of the many risk factors for developing this disease. The signs of osteonecrosis are:

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Genvoya

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister after {CAD}. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Genvoya Composition

The active ingredients areelvitegravir, 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 ingredients are

Tablet core:

Lactose (in the form of monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.

Film coating:

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

Appearance and Package Contents

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

This medication is available in packages of 1 bottle of 30 film-coated tablets and in packages of 90 (3 bottles of 30) film-coated tablets. Not all package sizes may be marketed.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:<{MM/AAAA}> <{month AAAA}>.

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