Elvitegravir & Cobicistat & Emtricitabine & Tenofovir

Elvitegravir/cobicistat/emtricitabine/tenofovir is a prescription medication used to treat human immunodeficiency virus (HIV) in adults who have never taken HIV medications before. Elvitegravir/cobicistat/emtricitabine/tenofovir is a single tablet containing four medications which together provide a complete treatment regimen for HIV infection. 

Emtricitabine and tenofovir 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.

Elvitegravir/cobicistat/emtricitabine/tenofovir is a prescription medication that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults who have never taken HIV-1 medicines before. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if elvitegravir/cobicistat/emtricitabine/tenofovir is safe and effective in children under 18 years of age.

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

• Stribild

Serious side effects have been reported. See "Drug Precautions" section.

The most common side effects of elvitegravir/cobicistat/emtricitabine/tenofovir include:

• nausea
• diarrhea

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

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider 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. 

Do not take elvitegravir/cobicistat/emtricitabine/tenofovir 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

You should not take elvitegravir/cobicistat/emtricitabine/tenofovir if you also take:

• any other medicines to treat HIV-1 infection
• other medicines that contain tenofovir (Atripla, Complera, Viread, Truvada)
• other medicines that contain emtricitabine or lamivudine (Combivir, Emtriva, Epivir, or Epivir-HBV, Epzicom, Trizivir)
• adefovir (Hepsera)

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 elvitegravir/cobicistat/emtricitabine/tenofovir.
• 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, Tegreto)
  • clarithromycin (Biaxin, Prevpac)
  • clonazepam (Klonopin)
  • clorazepate (Gen-Xene, Tranxene)
  • colchicine (Colcrys)
  • medicines that contain dexamethasone
  • 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 elvitegravir/cobicistat/emtricitabine/tenofovir 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 can cause serious side effects, including:

New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while you are taking elvitegravir/cobicistat/emtricitabine/tenofovir. Your healthcare provider may tell you to stop taking elvitegravir/cobicistat/emtricitabine/tenofovir if you develop new or worse kidney problems.

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.

• Do not run out of elvitegravir/cobicistat/emtricitabine/tenofovir. Refill your prescription or talk to your healthcare provider before your it is all gone.
• Do not stop taking elvitegravir/cobicistat/emtricitabine/tenofovir without first talking to your healthcare provider.
• If you stop taking elvitegravir/cobicistat/emtricitabine/tenofovir, 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 this medication.

Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take elvitegravir/cobicistat/emtricitabine/tenofovir 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 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 can happen in people who take elvitegravir/cobicistat/emtricitabine/tenofovir. 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

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

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

 

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

• alfuzosin hydrochloride (Uroxatral)
• cisapride (Propulsid)
• 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
• ergot-containing medicines, including:
  • ​dihydroergotamine mesylate (DHE 45, MIgranal)
  • ergotamine tartrate (Cafergot, Migergot, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes)
  • methylergonovine maleate (Ergotrate, Methergine)

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

Medicines 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 elvitegravir/cobicistat/emtricitabine/tenofovir there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking elvitegravir/cobicistat/emtricitabine/tenofovir, tell your healthcare provider if you:

• have liver problems including hepatitis B infection
• have kidney problems
• have bone problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Tell your healthcare provder if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Elvitegravir/cobicistat/emtricitabine/tenofovir falls into category B. There are no well-done studies that have been done in humans with but in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

There is a pregnancy registry for women who take antiviral medicines during pregnancy. 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 healthcare provider 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.
• Two of the medicines contained in this tablet can pass to your baby in your breast milk. It is not known if the other 2 medicines can pass into your breast milk.

• Take elvitegravir/cobicistat/emtricitabine/tenofovir exactly as your healthcare provider tells you to take it. Elvitegravir/cobicistat/emtricitabine/tenofovir is taken by itself (not with other antiretroviral medicines) to treat HIV-1 infection.
• Elvitegravir/cobicistat/emtricitabine/tenofovir is usually taken 1 time each day, with food.
• Do not change your dose or stop taking elvitegravir/cobicistat/emtricitabine/tenofovir without first talking with your healthcare provider. Stay under a healthcare provider's care when taking elvitegravir/cobicistat/emtricitabine/tenofovir.
• Do not miss a dose. If you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose of elvitegravir/cobicistat/emtricitabine/tenofovir, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
• If you take too much elvitegravir/cobicistat/emtricitabine/tenofovir, call your healthcare provider or go to the nearest hospital emergency room right away.
• 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 elvitegravir/cobicistat/emtricitabine/tenofovir 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.

Ask your healthcare provider if you have any questions about how to prevent passing HIV-1 to other people.

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

The recommended dose is one tablet (equal to 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir) taken once daily with food.

If you take too much elvitegravir/cobicistat/emtricitabine/tenofovir, call your healthcare provider or go to the nearest hospital emergency room right away.

• Store this medication at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep it in its original container.
• Keep the container tightly closed.
• Do not use if the seal over the bottle opening is broken or missing.

Keep elvitegravir/cobicistat/emtricitabine/tenofovir and all medicines out of reach of children.

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

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of elvitegravir/cobicistat/emtricitabine/tenofovir, in combination with other antiretrovirals.

Elvitegravir/cobicistat/emtricitabine/tenofovir is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and human immunodeficiency virus-1 (HIV-1) and have discontinued Emtriva or Viread, which are components of elvitegravir/cobicistat/emtricitabine/tenofovir. 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 elvitegravir/cobicistat/emtricitabine/tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted.