Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is a prescription medication used to treat human immunodeficiency virus (HIV) infection. It is a single product that contains 4 medications: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. 

Emtricitabine and tenofovir alafenamide belong to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). Elvitegravir belongs to a group of drugs called HIV integrase strand transfer inhibitor (HIV-1 INSTI). Elvitegravir, emtricitabine, and tenofovir work by decreasing the amount of HIV in the blood.

Cobicistat belongs to a group of drugs called CYP3A inhibitors. Cobicistat helps to keep elvitegravir in the body longer so that the medication will have a greater effect.

This medication comes in tablet form and is taken once daily with food.

Common side effects include nausea and increases in cholesterol.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 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.

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 Elvitegravir/cobicistat/emtricitabine/tenofovir, your doctor should test you for hepatitis B virus infection. Before starting Elvitegravir/cobicistat/emtricitabine/tenofovir 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 is one tablet (equal to 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide) taken once daily with food.

WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

See full prescribing information for complete boxed warning.

• This medication is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued Emtriva or Viread, two of the components of this medication. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Serious side effects have been reported with this medication, and certain precautions should be followed:

• Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take this medication or similar (nucleoside analogs) medicines. 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
    • vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat

You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking this medication for a long time.

• Severe liver problems. Severe liver problems can happen in people who take this medication. 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 this medication, your HBV may get worse (flare-up) if you stop taking this medication. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.
  • Do not run out of this medication. Refill your prescription or talk to your healthcare provider before it is all gone.
  • Do not stop taking this medication without first talking to your healthcare provider.
  • If you stop taking this medication, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking elvitegravir/cobicistat/emtricitabine/tenofovir.
• Bone problems can happen in some people who take this medication. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do tests to check your bones.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. 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 your HIV-1 medicine.
• New or worsening kidney problems. Toxicity from this medication 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 this medication. 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 this medication if you are allergic to it or to any of the inactive ingredients.

Serious side effects have been reported with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. See the "Drug Precautions" section.

Common side effects include the following:

• nausea
• diarrhea
• headache
• tiredness

This is not a complete list of 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 this medication 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 this medication 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 this medication 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.

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

It is not known if this medication can harm your unborn baby.

There is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to this medication. 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. Do not breastfeed if you take this medication.

• You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
• 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.

When your 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 this medication and become harder to treat.

Elvitegravir/cobicistat/emtricitabine/tenofovir can cause changes in body fat. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen.

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