Genvoya

Genvoya is a prescription medication used to treat human immunodeficiency virus (HIV). It is a single product containing 4 medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. 

Elvitegravir belongs to a group of drugs called HIV integrase strand transfer inhibitor (HIV-1 INSTI). Cobicistat belongs to a group of drugs called CYP3A inhibitors. Cobicistat helps to keep the other medications in the body longer so that the medication will have a greater effect. Emtricitabine and tenofovir belong to a group of drugs called nucleoside reverse transcriptase inhibitors. Together these drugs work to decrease the presence of HIV in the blood.

This medication is available in tablet form and is typically taken once a day with food.

Common side effects of Genvoya include nausea and increases in cholesterol.

Genvoya is a prescription medication used to treat human immunodeficiency virus (HIV) in adults and pediatric patients 12 years of age and older:

• who have not received anti-HIV-1 medicines in the past, or
• to replace their current anti-HIV-1 medicines:
  • in people who have been on the same anti-HIV-1 medicine regimen for at least 6 months, and
  • who have an amount of HIV-1 in their blood (this is called 'viral load') that is less than 50 copies/mL, and
  • have never failed past HIV-1 treatment.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Gilead Sciences, Inc.

Serious side effects have been reported with Genvoya. See the "Genvoya Precautions" section.

Common side effects of Genvoya include the following:

• nausea
• diarrhea
• headache
• tiredness

This is not a complete list of Genvoya side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

You should not take Genvoya if you take:

• any other medicines to treat HIV-1 infection, including
  • efavirenz/emtricitabine/tenofovir (Atripla)
  • rilpivirine (Edurant)
  • emtricitabine (Emtriva)
  • elvitegravir, cobicistat, emtricitabine, and tenofovir (Stribild)
  • tenofovir and emtricitabine (Truvada)
  • tenofovir (Viread)
  • adefovir (Hepsera)

Do not take Genvoya if you also take a medicine that contains:

• alfuzosin hydrochloride (Uroxatral)
• atorvastatin (Lipitor)
• cisapride (Propulsid, Propulsid Quicksolv)
• drospirenone/ethinyl estradiol (Yasmin, Yaz)
• ergot-containing medicines, including:
  • dihydroergotamine mesylate (D.H.E. 45, Migranal)
  • ergotamine tartrate (Cafergot, Migergot, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes)
  • methylergonovine maleate (Ergotrate, Methergine)
• lovastatin (Advicor, Altoprev, Mevacor)
• oral midazolam
• pimozide (Orap)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• sildenafil (Revatio), when used for treating the lung problem, pulmonary arterial hypertension (PAH)
• simvastatin (Simcor, Vytorin, Zocor)
• triazolam (Halcion)
• St. John's wort (Hypericum perforatum) or a product that contains St. John's wort

Especially tell your healthcare provider if you take:

• hormone-based contraceptives (birth control pills and patches)
• an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take Genvoya.
• medicines to treat depression
• medicines to prevent organ transplant rejection
• medicines to treat high blood pressure
• any of the following medicines:
  • amiodarone (Cordarone, Pacerone)
  • atorvastatin (Lipitor, Caduet)
  • bepridil hydrochloric (Vascor, Bepadin)
  • bosentan (Tracleer)
  • buspirone
  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • clarithromycin (Biaxin, Prevpac)
  • clonazepam (Klonopin)
  • clorazepate (Gen-Xene, Tranxene)
  • colchicine (Colcrys)
  • medicines that contain dexamethasone or other corticosteroids
  • diazepam (Valium)
  • digoxin (Lanoxin)
  • disopyramide (Norpace)
  • estazolam
  • ethosuximide (Zarontin)
  • flecainide (Tambocor)
  • flurazepam
  • fluticasone (Flovent, Flonase, Flovent Diskus, Flovent HFA, Veramyst)
  • itraconazole (Sporanox)
  • ketoconazole (Nizoral)
  • lidocaine (Xylocaine)
  • mexiletine
  • oxcarbazepine (Trileptal)
  • perphenazine
  • phenobarbital (Luminal)
  • phenytoin (Dilantin, Phenytek)
  • propafenone (Rythmol)
  • quinidine (Neudexta)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)
  • risperidone (Risperdal, Risperdal Consta)
  • salmeterol (Serevent) or salmeterol when taken in combination with fluticasone (Advair Diskus, Advair HFA)
  • sildenafil (Viagra), tadalafil (Cialis) or vardenafil (Levitra, Staxyn), for the treatment of erectile dysfunction (ED). If you get dizzy or faint (low blood pressure), have vision changes or have an erection that last longer than 4 hours, call your healthcare provider or get medical help right away.
  • tadalafil (Adcirca), for the treatment of pulmonary arterial hypertension
  • telithromycin (Ketek)
  • thioridazine
  • voriconazole (Vfend)
  • warfarin (Coumadin, Jantoven)
  • zolpidem (Ambien, Edluar, Intermezzo, Zolpimist)

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Do not start any new medicines while you are taking Genvoya without first talking with your healthcare provider or pharmacist.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Serious side effects have been reported with Genvoya including the following:

Lactic acidosis. Build up of lactic acid in your bloodLactic acidosis can happen in some people who take Genvoya. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:

• feel very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with nausea or vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat

Severe liver problems. Severe liver problems may happen in people who take Genvoya. In some cases, these liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider right away if you get any of the following symptoms of liver problems:

• your skin or the white part of your eyes turns yellow (jaundice)
• dark "tea-colored" urine
• light-colored bowel movements (stools)
• loss of appetite for several days or longer
• nausea
• stomach pain

Worsening of Hepatitis B infection. If you have hepatitis B virus (HBV) infection and take Genvoya, your HBV may get worse (flare-up) if you stop taking Genvoya. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.

Immune Reconstitution Syndrome. Changed in your immune system may happen when you start taking Genvoya. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting Genvoya.

• Do not run out of Genvoya. Refill your prescription or talk to your healthcare provider before your it is all gone.
• Do not stop taking Genvoya without first talking to your healthcare provider.

New or worsening kidney problems. Toxicity from Genvoya may occur with kidney dysfunction. Your doctor may want to monitor your kidneys with certain blood or urine tests before you start taking and while taking Genvoya. Tell your healthcare provider right away if your have any of the following symptoms of kidney dysfunction:

• swelling of face, ankles, hands, or feet
• fatigue
• paleness of skin
• decreased urination
• shortness of breath
• change in blood pressure

Do not take Genvoya if you are allergic to it or to any of the inactive ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Genvoya, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Genvoya, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Genvoya or any of its ingredients
• have kidney problems
• have liver problems
• have a Hepatitis B infection
• have bone problems
• are pregnant or planning to become pregnant
• are breastfeeding or planning to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if Genvoya can harm your unborn baby.

There is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to Genvoya. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking Genvoya.

• Due to the risk of passing HIV to your baby in your breastmilk, you should not breastfeed if you have HIV.
• One of the medicines contained in this tablet can pass to your baby in your breast milk. It is not known if the other 3 medicines can pass into your breast milk.

Take Genvoya exactly as prescribed.

Genvoya comes in tablet form and is typically taken once a day with food.

Genvoya is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.

Do not change your dose or stop taking Genvoya without first talking with your healthcare provider. Stay under a healthcare provider's care when taking Genvoya.

If you need to take a medicine for indigestion (antacid) that contains aluminum and magnesium hydroxide or calcium carbonate during treatment with Genvoya, take it at least 2 hours before or after you take Genvoya.

Do not miss a dose of Genvoya. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Genvoya at the same time.

When your Genvoya supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Genvoya and become harder to treat.

Avoid doing things that can spread HIV-1 infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Before you start taking Genvoya, your doctor should test you for hepatitis B virus infection. Before starting Genvoya and while you take the medication, your doctor may require additional lab tests, such as serum creatinine, estimated creatinine clearance, urine glucose, and urine protein, and also assess serum phosphorus in patients with chronic kidney disease. 

The recommended dose of Genvoya is one tablet (equal to 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide) taken once daily with food.

If you take too much Genvoya, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Genvoya below 86 °F (30 °C).

Keep Genvoya in its original container and keep it tightly closed.

Keep Genvoya and all medicines out of the reach of children.

WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Genvoya is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Genvoya have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with Genvoya. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Genvoya. If appropriate, initiation of anti-hepatitis B therapy may be warranted.