Genvoya - Elvitegravir / cobicistat / emtricitabine / tenofoviralafenamide uses, dose and side effects

elvitegravir, an antiretroviral medicine called an integrase inhibitor
cobicistat, a booster (enhancer) of the effects of elvitegravir
emtricitabine, an antiretroviral medicine called a nucleoside reverse transcriptase inhibitor (NRTI)
tenofoviralafenamide , an antiretroviral medicine called a nucleotide reverse transcriptase inhibitor (NtRTI).

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

Genvoya reduces the amount of HIV in the body. This strengthens the immune system and the risk of developing illnesses associated with HIV – infection decreases.

2. What you need to know before taking Genvoya

Do not take Genvoya

If you are allergic to elvitegravir, cobicistat, emtricitabine, tenofoviralafenamide , or any of the other ingredients of this medicine (listed in section 6 of the Package Leaflet).
If you are taking any of these medicines:– alfuzosin (used to treat enlarged prostate gland)- 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 s)– dihydroergotamine, ergometry, ergotamine (used to treat migraines )– cisapride (used to relieve certain stomach problems)– St. John’s Wort ( Hypericum perforatum , a (traditional) herbal medicines used to easily depressed mood and mild anxiety) or products containing St. John’s wort– lomitapid, 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 that makes it difficult to breathe)– midazolam (taken by mouth) , triazolam (used to help you sleep and / or reduce anxiety)

→ If any of these apply to you, do not take Genvoya and inform your doctor immediately.

Warnings and cautions

Your Genvoya treatment must be constantly monitored by a doctor.

You can still transmit HIV infection when you take this medicine, even though the risk of effective antiretroviral therapy is reduced . Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV – infection . While taking Genvoya you may still develop infections you or other illnesses associated with HIV – infection .

Talk to your doctor before taking Genvoya:

if you have liver problems or have had liver disease, including hepatitis . Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral agents are at increased risk for severe and potentially fatal liver complications. If you have hepatitis B infection , your doctor will carefully choose the best treatment for you.
If you have a hepatitis B infection , your liver problems may worsen after you stop taking Genvoya. It is important that you do not stop taking Genvoya without talking to your doctor (see section 3, Do not stop taking Genvoya ).
if you have had kidney disease or if tests have shown that you have kidney problems. Your doctor may order blood tests to check how your kidneys are working at the start and during treatment with Genvoya.

When you take Genvoya

Once you have started taking Genvoya, you should be observant of:

Signs of inflammation or infection
Joint pain, stiffness or problems with the skeleton

→ Contact your doctor immediately if you get any of these symptoms. See section 4, Possible side effect is , for more information.

Even if kidney problems have not been observed with Genvoya, there is a risk that you will have kidney problems when you take Genvoya for a long time (see Warnings and Precautions ).

Children and young people

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 in children aged 5 years and younger has not yet 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 affect or be affected by other medicines. This may affect the amount of Genvoya or other medicines in the blood. The medicines may then not work properly or any side effects may be exacerbated. In some cases, your doctor may need to change the dose or check the amount of medicine in your blood.

Medicines that must never be taken with Genvoya:

– alfuzosin (used to treat enlarged 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 s)

– dihydroergotamine, ergometry, ergotamine (used to treat migraine headaches)

– cisapride (used to relieve certain stomach problems)

– St. John’s Wort ( Hypericum perforatum , a (traditional) herbal medicines used to easily depressed mood and mild anxiety) or products containing St. John’s wort .

– lomitapid, 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 that makes it difficult to breathe)

– midazolam (taken by mouth) , triazolam (used to help you sleep and / or reduce anxiety)

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

Drugs used to treat hepatitis B infection:

You should not take Genvoya with medicines containing:

tenofoviralafenamide
tenofovir disoproxil
lamivudine
adefovir dipivoxil

→ Contact 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 , which contain:rifabutin, clarithromycin and telithromycin
antidepressants, used to treat depression:- medicines containing trazodone or escitalopram
sedatives and hypnotics , used to treat anxiety:buspirone, chlorazepate, diazepam , estazolam, flurazepam, zolpidem and lorazepam
immunosuppressive, used to control the body’s immune system after a transplant, e.g .:ciclosporin, sirolimus and tacrolimus
Corticosteroids are, including:- betamethasone, budesonide, fluticasone , mometasone, prednisone, triamquinoloneThese medicines are used to treat allergies , asthma , inflammatory bowel diseases, inflammation of the eyes, joints and muscles and other inflammatory conditions. If there are no alternatives, the medicine should be used only after a doctor’s evaluation and under the close supervision of your doctor for side effects of corticosteroids .
drugs used to treat diabetes :- metformin
birth control pills , used to prevent pregnancy
drugs for erectile dysfunction , used to treat impotence , e.g .:- sildenafil, tadalafil and vardenafil
cardiac drugs, eg:- digoxin , disopyramide , flecainide , lidocaine (injectable), mexiletine, propafenone , metoprolol , timolol , amlodipine, diltiazem , felodipine, nicardipine, nifedipine and verapamil
drugs used to treat pulmonary arterial hypertension :- bosentan and tadalafil
anticoagulants , are used to prevent and treat blood clots, eg:apixaban, edoxaban, rivaroxaban and warfarin
bronchodilators , used to treat asthma and other lung problems:- salmeterol
cholesterol-lowering drugs, eg:atorvastatin and pitavastatin
drugs used to treat gout :- colchicine

antiplatelet drugs , used to reduce the risk of blood clots, such as:

-klopidogrel

medicines or supplements containing minerals (such as magnesium , aluminum, calcium , iron, zinc) , eg:

-mineral supplements, vitamins (including multivitamins), antacids (medicines for acid stomachs) and laxatives .

→ If you are taking medicines, supplements, antacids or laxatives that contain minerals (such as magnesium , aluminum, calcium , iron, zinc) , take them at least 4 hours before or at least 4 hours after Genvoya.

→ Tell your doctor if you are taking any of these or other medicines. You should not stop treatment without talking to your doctor.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, 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. Pregnant women should not take Genvoya. The amount of this drug in the blood may decrease during pregnancy, which may cause it to stop working properly.
Use an effective method of contraception while taking Genvoya.
Do not breast-feed during treatment with Genvoya. This is because some of the active substances in this medicine pass into breast milk. To avoid transmitting HIV to your baby through breast milk, do not breast-feed your baby.

Driving and using machines

Genvoya can cause dizziness. Do not drive or use bicycles or use tools or machines if you feel dizzy while taking Genvoya.

Genvoya contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.

Genvoya contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

→ If any of these apply to you, talk to your doctor before taking Genvoya.

3. How to take Genvoya

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults: one tablet a day with food

Adolescents and children aged 6 years and older, weighing at least 25 kg: one tablet a day with food.

Due to the bitter taste, it is recommended not to chew or crush the tablet.

If you have difficulty swallowing the tablet whole, you can divide it in half. Take both halves of the tablet, one at a time, to get the full dose one. Do not save the split tablet.

Always take the dose prescribed by your doctor to ensure that the medicine is 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 multivitamins at the same time as Genvoya. If you are taking medicines, supplements , antacids or laxatives that contain minerals (such as magnesium , aluminum, calcium , iron, zinc), take them at least 4 hours before or at least 4 hours after Genvoya.

If you are on dialysis , you should take your daily dose of Genvoya after dialysis has been completed.

If you take more Genvoya than you should

If you accidentally take more than the prescribed dose of Genvoya the risk of side effects is with this drug increase (see section 4, Possible side effect s ).

Contact your doctor or nearest emergency department immediately for advice. Save the jar so 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 it within 18 hours after the time you usually take Genvoya, you must take the tablet as soon as possible. The tablet must always be taken with food. Then take the next dose as usual.
If you notice it 18 hours or more after the time you usually take Genvoya, do not take the missed dose . Wait and take the next dose of food at its regular time.

If you vomit within less than 1 hour after a dose of Genvoya, take a new tablet of food.

Do not stop taking Genvoya

Do not stop taking Genvoya without talking to your doctor . If you stop taking Genvoya, it may seriously affect the effect of future treatment. If for any reason you stop taking Genvoya, talk to your doctor before taking Genvoya tablets again.

When your Genvoya supply starts to run low , get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop taking the medicine for a short time. The disease can then become more difficult to treat.

If you have both HIV – infection and hepatitis B, it is especially important not to stop Genvoya treatment without first talking to your doctor. You may need to submit blood samples for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis , discontinuation of treatment is not recommended, as this may lead to worsening of hepatitis A, which may be life-threatening.

→ Tell your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you associate with hepatitis B infection .

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

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Possible serious side effects: Contact a doctor immediately

Signs of inflammation or infection . In some patients with advanced HIV – infection ( AIDS ) who have a history of opportunistic infection, you ( infection s that occur in people with weakened immune systems) may be signs and symptoms of inflammation from previous infections you occur shortly after HIV treatment is started . It is believed that these symptoms are due to the fact that the body’s immune system has been strengthened so that the body can fight infections that may have been present without giving any clear symptoms.
Autoimmune diseases, where the immune system attacks healthy body tissue, can also occur after you start taking medicines for HIV – infection . Autoimmune diseases can occur many months after starting treatment. Be observant of symptoms of infection or other symptoms such as:- muscle weaknessweakness that begins in the hands and feet and moves towards the torsopalpitations, tremors or hyperactivity.
→ If you notice the side effects described above, tell your doctor immediately.

Very common side effects are

( Can occur in more than 1 of 10 users )

nausea

Common side effects are

( May occur in up to 1 of 10 users )

abnormal dreams
headache
dizziness
diarrhea
vomiting
abdominal pain
gas production ( flatulence )
rash
fatigue

Uncommon side effects are

( May occur in up to 1 in 100 users )

low red blood cell count ( anemia )
suicidal ideation and suicide attempts (in patients with a history of depression or mental health problems), depression
indigestion which results in discomfort after meals ( dyspepsia )
swelling of the face, lips, tongue or throat ( angioedema )
itching ( pruritus )
hives ( urticaria )

→ If any side effects get worse, talk to your doctor.

Other effects that can be seen with HIV treatment

The frequency of the following side effects is not known (frequency can not be calculated from the available data).

Skeletal problem. Some patients taking combination antiretroviral medicines like Genvoya may develop a skeletal disease called osteonecrosis (bone tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing this disease are long-term use of this type of drug, treatment with corticosteroids, alcohol consumption, a very weak immune system and obesity. Signs of osteonecrosis are:joint stiffness- joint pain and pain (especially in hips, knees and shoulders)- mobility difficulties

→ Tell your doctor if you notice any of these symptoms.

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

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 which is stated on the carton and can after {EXP}. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. Close the jar tightly.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are elvitegravir, cobicistat , emtricitabine and tenofoviralafenamide. One Genvoya film-coated tablet contains 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and tenofoviralafenamide fumarate equivalent to 10 mg tenofoviralafenamide.

Other ingredients are

Tablet core:

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

Film coating:

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

What the medicine looks like and contents of the pack

Genvoya film-coated tablets are green, capsule-shaped tablets. Embossed on one side with “GSI” and on the other side with the number “510”. Genvoya is supplied in jars containing 30 tablets (with desiccant in the form of silica gel which must be stored in the jar to protect the tablets from moisture). The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.

The following pack sizes are available: Outer cartons containing 1 can of 30 film-coated tablets and outer cartons containing 90 (3 cans of 30) film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer