Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide

This medication treats HIV. Do not skip any doses as this may make it more difficult to treat HIV.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Overview

Reviewed: January 10, 2014
Updated: 

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.

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Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Cautionary Labels

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Uses of Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide

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.

 

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Brand Names

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide may be found in some form under the following brand names:

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Drug Class

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide is part of the drug class:

Side Effects of Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide

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.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Interactions

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:

Do not take this medication if you also take a medicine that contains:

  • alfuzosin hydrochloride (Uroxatral)
  • cisapride (Propulsid, Propulsid Quicksolv)
  • 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.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Precautions

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 body fat can happen in people who take HIV-1 medicine. 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. The exact cause and long-term health effects of these conditions are not known.
  • 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.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Food Interactions

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 this medication, there are no specific foods that you must exclude from your diet when receiving this medication.

 

Inform MD

Before taking this medication, tell your healthcare provider if you:

  • are allergic to this medication 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 healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide and Pregnancy

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.

 
 

 

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide and Lactation

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.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Usage

Take this medication exactly as prescribed.

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

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

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

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

Do not miss a dose of this medication. 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 this medication at the same time.

When your medication 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.

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.

 

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Dosage

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

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.

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide Overdose

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

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

  • Store this medication below 86 °F (30 °C).
  • Keep in its original container.
  • Keep the container tightly closed.
  • Do not use if the seal over the bottle opening is broken or missing.
  • Keep and all medicines out of reach of children.
 

Elvitegravir & Cobicistat & Emtricitabine & Tenofovir alafenamide FDA Warning

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF

HEPATITIS B

See full prescribing information for complete boxed warning.

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (DF), a component of this medication.
  • 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.