This product is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product contains 4 different medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Elvitegravir is known as an integrase inhibitor. Cobicistat helps elvitegravir work better. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor; both kinds of drugs are often called NRTIs.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily.

It is very important to continue taking this medication exactly as prescribed by your doctor. Do not skip any doses.

If you take antacids, take the antacids at least 2 hours before or 2 hours after this medication.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Genvoya can harm your liver. Call your doctor at once if you have: upper stomach pain, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Do not stop using Genvoya without your doctor's advice. Get your prescription refilled before you run out of medicine completely.

If you've ever had hepatitis B, it may become active or get worse after you stop using Genvoya. You may need frequent liver function tests for several months.

Many drugs can interact with this medicine and some should not be used at the same time. Tell your doctor about all the medicines you use.

You should not take Genvoya if you are allergic to cobicistat, elvitegravir, emtricitabine, or tenofovir.

Some medicines can cause unwanted or dangerous effects when used with cobicistat, elvitegravir, emtricitabine, and tenofovir. Your doctor may change your treatment plan if you also use:

• alfuzosin;
• cisapride;
• oral midazolam, or triazolam;
• rifampin;
• sildenafil (Revatio, for treating pulmonary arterial hypertension);
• St. John's wort;
• antipsychotic medicine - lurasidone, pimozide;
• cholesterol medication - lomitapide, lovastatin, simvastatin;
• ergot medicine - dihydroergotamine, ergotamine, methylergonovine; or
• seizure medicine - carbamazepine, phenobarbital, phenytoin.

Genvoya is a complete combination treatment and should not be used with other antiviral medications, especially those that contain adefovir, cobicistat, elvitegravir, emtricitabine, lamivudine, ritonavir, or tenofovir: Atripla, Biktarvy, Cimduo, Combivir, Complera, Descovy, Epivir, Epzicom, Evotaz, Hepsera, Kaletra, Norvir, Odefsey, Prezcobix, Symfi, Symtuza, Technivie, Triumeq, Trizivir, Tybost, Viekira, and others.

To make sure Genvoya is safe for you, tell your doctor if you have ever had:

• hepatitis B or other liver problems;
• kidney disease; or
• bone problems.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

This medicine may not work as well if you take it during pregnancy. Do not start taking the medicine if you are pregnant. Tell your doctor right away if you become pregnant.

If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. Use all medications properly to control your infection.

HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

If you do not plan to get pregnant, ask your doctor about using a non- hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy. Cobicistat, elvitegravir, emtricitabine, and tenofovir can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Diarrhea, nausea, headache, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), signs of kidney problems (such as change in the amount of urine, pink/bloody urine).

Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What should I avoid while taking Genvoya?

Avoid taking an antacid within 2 hours before or 2 hours after you take Genvoya. Some antacids can make it harder for your body to absorb this medicine.

Using Genvoya will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What other drugs will affect Genvoya?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with cobicistat, elvitegravir, emtricitabine, and tenofovir. Some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.