Genvoya

Package leaflet: Information for the user

Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets, 90 mg/90 mg/120 mg/6 mg film-coated tablets

elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 the information
contained in this leaflet applies to your child (in this case, read “your child” instead of
“you”).

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 medicine that enhances (booster) 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-1 (HIV-1) infection in adults, adolescents, and children aged 2 years and older weighing at least 14 kg.
Genvoya reduces the amount of HIV in your body. This improves your immune system and reduces the risk of developing HIV-related illnesses.

2. What you should know before taking Genvoya

Do not take Genvoya

• If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide or to any of the other ingredients of this medicine (listed in section 6 of this leaflet).
• If you are taking any of the following medicines:
  • alfuzosin (used to treat enlargement of the prostate gland)
• 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 migraine headaches)
• cisapride (used for certain stomach problems)
• St John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or preparations containing it
• lomitapide, lovastatin, simvastatin (used to lower blood cholesterol)
• lurasidone, pimozide (used to treat abnormal thoughts or feelings)
• sildenafil (when used to treat pulmonary arterial hypertension, a lung disease causing breathing difficulties)
• midazolam taken orally, triazolam (used to help sleep and/or relieve anxiety)

If any of these apply to you, do not take Genvoya and inform your doctor immediately.
Warnings and precautions
While taking Genvoya, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking Genvoya, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Genvoya:

• If you have or have previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe liver complications, which may even lead to death. If you have hepatitis B, your doctor will carefully assess the best treatment regimen for you.

If you have hepatitis B, liver problems may worsen when you stop treatment with Genvoya. It is important that you do not stop treatment with Genvoya without speaking to your doctor: see section 3, Do not stop treatment with Genvoya.

• If you have kidney disease or if tests have shown problems with your kidneys. Your doctor may request blood tests to monitor how well your kidneys are functioning at the beginning and during treatment with Genvoya.

While taking Genvoya
When 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.
Kidney problems may occur during long-term use of Genvoya (see Warnings and precautions).
Children and adolescents
Do not give this medicine to children under 2 years of age or weighing less than 14 kg, regardless of age. The use of Genvoya in children under 2 years of age or weighing less than 14 kg has not been studied.
Other medicines and Genvoya
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Genvoya can interact with other medicines. As a result, the amount of Genvoya or other medicines in your blood may be altered. This may prevent the medicines from working properly or may worsen their side effects. In some cases, your doctor may need to adjust the dose or monitor blood levels.
Medicines that must never be taken with Genvoya:

• alfuzosin (used to treat enlargement of the prostate gland)
• 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 migraine headaches)
• cisapride (used for certain stomach problems)
• St John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety) or preparations containing it
• lomitapide, lovastatin, simvastatin (used to lower blood cholesterol)
• lurasidone, pimozide (used to treat abnormal thoughts or feelings)
• sildenafil (when used to treat pulmonary arterial hypertension, a lung disease causing breathing difficulties)
• 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:
You must not take Genvoya together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

Inform 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 immune response after transplantation, such as:
  • ciclosporin, sirolimus and tacrolimus
• corticosteroids, including:
  • betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammatory skin, eye, joint and muscle conditions, and other inflammatory conditions. These medicines are usually taken orally, inhaled, injected, or applied to the skin or eyes. If alternative treatments cannot be used, these medicines may only be taken after evaluation by your doctor and under close medical monitoring to detect any corticosteroid-related side effects.
• 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 (injectable), 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 disorders:
  • salmeterol
• cholesterol-lowering medicines, such as:
  • atorvastatin and pitavastatin
• medicines used to treat gout:
  • colchicine
• antiplatelet agents, used to reduce the risk of blood clots, such as:
  • clopidogrel
• oral medicines or supplements containing minerals (such as magnesium, aluminium, calcium, iron, zinc), such as:
  • mineral supplements, vitamins (including multivitamins), antacids and laxatives If you are taking medicines, oral supplements, antacids or laxatives containing minerals (such as magnesium, aluminium, calcium, iron, zinc), take them at least 4 hours before or at least 4 hours after taking Genvoya.

Inform your doctor if you are taking these or any other medicines. Do not stop treatment without contacting your doctor.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, 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 a pregnancy. Pregnant women must not take Genvoya. The amount of this medicine in the blood may decrease during pregnancy, which may prevent the medicine from working properly.
• Use an effective method of contraception while taking Genvoya.
• Do not breastfeed during treatment with Genvoya. This is because some of the active substances in this medicine are excreted in human breast milk. Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Genvoya may cause dizziness. If you experience dizziness while taking Genvoya, do not drive, cycle, or use tools or machines.
Genvoya contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.
Genvoya contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
If any of these conditions apply to you, talk to your doctor before taking Genvoya.

3. How to take Genvoya

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
There are two dosage strengths of Genvoya tablets. Your doctor will prescribe the appropriate tablet based on your age and body weight.

The recommended dose is:
Adults, adolescents, and children weighing at least 25 kg: one tablet daily, taken with food (one 150 mg/150 mg/200 mg/10 mg tablet).
Children aged 2 years and older, weighing at least 14 kg but less than 25 kg: one tablet daily, taken with food (one 90 mg/90 mg/120 mg/6 mg tablet).

Due to the bitter taste, it is recommended not to chew or crush the tablet.
If you have difficulty swallowing the tablet whole, you may split it in half. Take both halves of the tablet one after the other to ensure the full dose is taken. Do not store the split tablet.
The break line on the 90 mg/90 mg/120 mg/6 mg tablet is intended only to facilitate splitting the tablet if the child has difficulty swallowing it whole.

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

Do not take antacids or multivitamin preparations at the same time as Genvoya. If you are taking medicines, oral supplements, antacids, or mineral-containing laxatives (such as magnesium, aluminium, calcium, iron, zinc), take them 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 completion of dialysis.

If you take more Genvoya than you should
If you accidentally take more Genvoya than prescribed, you may have an increased risk of experiencing possible side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately. Take the medicine container with you so you can easily describe what has been taken.

If you forget to take Genvoya
It is important not to miss any doses of Genvoya.
If you forget a dose:

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

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

If you stop taking Genvoya
Do not stop taking Genvoya without talking to your doctor. Stopping treatment with Genvoya may seriously affect your response to future treatment. If treatment with Genvoya is stopped for any reason, discuss it with your doctor before restarting the tablets.

When your supply of Genvoya starts to run low, ask your doctor or pharmacist for a new supply. This is very important because the amount of virus in your body may start to increase if the medicine is stopped, even for a short time. The disease may then become 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. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis, which could potentially be fatal.

Contact your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly symptoms normally associated with hepatitis B infection.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible serious side effects: inform your doctor immediately

• Signs 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 be due to an improved immune response, which enables 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 body tissues when you start taking medicines for HIV infection. Autoimmune disorders may occur many months after starting treatment. Be alert for any signs of infection or other symptoms such as:
  • muscle weakness
  • weakness starting in the hands and feet and progressing towards the trunk
  • palpitations, tremor, or hyperactivity.

If you experience any of the above side effects, inform your doctor immediately.
Very common side effects
(may occur in more than 1 in 10 people)

• feeling unwell (nausea)

Common side effects
(may occur in up to 1 in 10 people)

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

Uncommon side effects
(may occur in up to 1 in 100 people)

• low red blood cell count (anaemia)
• 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 sensation
• hives (urticaria)

If any of these side effects worsen, inform your doctor.
Other possible side effects observed during HIV treatment
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).

• Bone problems. Some patients taking combination antiretroviral medicines such as Genvoya may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Taking this type of medicine for a prolonged period, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:

• joint stiffness

• discomfort and pain in the joints (especially in the hips, knees, and shoulders)

• difficulty in moving If you notice any of these symptoms, inform your doctor.

During HIV treatment, an increase in weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Genvoya contains
The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

• Each 150 mg/150 mg/200 mg/10 mg film-coated tablet of Genvoya contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide.
• Each 90 mg/90 mg/120 mg/6 mg film-coated tablet of Genvoya contains 90 mg of elvitegravir, 90 mg of cobicistat, 120 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 6 mg of tenofovir alafenamide.

The other components are
Tablet core:
Lactose (as monohydrate), microcrystalline cellulose (E460), croscarmellose sodium,
hydroxypropylcellulose (E463), silicon dioxide (E551), sodium lauryl sulfate, magnesium stearate.
Film coating:
Polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol (E1521), talc (E553b), yellow iron oxide (E172), indigo carmine, indigo carmine (E132 – only in the 150 mg/150 mg/200 mg/10 mg tablet), black iron oxide (E172 – only in the 90 mg/90 mg/120 mg/6 mg tablet).
Description of the appearance of Genvoya and contents of the pack
The 150 mg/150 mg/200 mg/10 mg film-coated tablets of Genvoya are green, capsule-shaped, imprinted on one side with “GSI” and on the other side with the number “510”.
The 90 mg/90 mg/120 mg/6 mg film-coated tablets of Genvoya are green, capsule-shaped, imprinted on one side with “GSI” and engraved on the other side of the tablet.
Genvoya is supplied in bottles containing 30 tablets (with a desiccant silica gel, which must remain in the bottle to protect the tablets). The silica gel is contained in a separate sachet or container and must not be swallowed.
The following pack sizes are available: cardboard box containing 1 bottle with 30 film-coated tablets and cardboard box containing 90 (3 bottles of 30) film-coated tablets. Not all 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:
België/Belgique/Belgien Lietuva
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Тел.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 24 01 35 50
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Gilead Sciences Poland Sp. z o.o. Gilead Sciences Sweden AB
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Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
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Latvija United Kingdom (Northern Ireland)
Gilead Sciences Poland Sp. z o.o. Gilead Sciences Ireland UC
Tel: + 48 22 262 8702 Tel: + 44 (0) 8000 113 700
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.