Elvitegravir/Cobicistat/Emtricitabine/Tenofovir, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV infection. It is not a cure for HIV infection. Take it exactly as directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.
• This medicine may cause a buildup of lactic acid in the blood that can be dangerous. This medicine may also cause severe or life-threatening liver problems. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: elvitegravir/cobicistat/emtricitabine/tenofovir, oral; Genvoya; Stribild

What is this medicine used for?

This medicine is a combination of 4 medicines in each tablet. It is taken by mouth to treat HIV infection. It will not cure HIV or AIDS but may slow the progression of the disease. It should not be used with any other anti-HIV medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bone problems such as osteoporosis
• Hepatitis B or other liver disease
• Kidney disease

This medicine may interact with many other medicines. This medicine may change the effect of other medicines, including the ones for HIV, and may cause serious side effects. Do not take this medicine if you also take any other medicine to treat HIV. Your healthcare provider may change your other medicines or change their doses. Other medicines, including herbal products, may affect this medicine. For this reason, it is very important to tell healthcare providers and pharmacists all the prescription medicines, nonprescription medicines, natural remedies, or vitamins you take.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less. Do not stop taking this medicine without your healthcare provider's approval.

Do not run out of this medicine. 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 medicine and become harder to treat.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine with food. Take the medicine at the same time each day to help you remember to take it.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is time for your next dose (the next day). In that case, skip the missed dose and use the next one as directed. Do not double the dose the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause a severe or life-threatening condition called lactic acidosis (a buildup of acid in your blood). Contact your healthcare provider right away if you develop unexplained symptoms such as:

• Feeling very weak or tired
• Unusual muscle pain
• Having trouble breathing
• Stomach pain with nausea and vomiting
• Feeling cold, especially in your arms or legs
• Feeling dizzy or lightheaded
• Fast or irregular heartbeat

This medicine may cause severe or life-threatening liver problems. Contact your healthcare provider right away if you have yellowing of your skin or eyes, dark urine, light-colored bowel movements, and loss of appetite.

This medicine is not approved to treat hepatitis B. Your healthcare provider may test you for hepatitis B. If you are also infected with hepatitis B, you need blood tests and checkups for several months after you stop taking this medicine. This medicine may cause flare-ups of hepatitis B.

This medicine may cause dizziness or drowsiness. Do not drive or operate machinery unless you are fully alert.

This medicine may increase the effects of alcohol and other drugs that affect your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Treatment with this medicine may cause a change in the location of fat in your body. Talk with your healthcare provider about this.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

Your healthcare provider may prescribe calcium and vitamin D supplements while you are taking this medicine. Follow your healthcare provider's instructions about exercise, diet, and taking vitamin supplements.

You need to have lab tests regularly to see how this medicine affects you. You may also need bone scans or X-rays to see if the medicine is affecting your bones. Keep all appointments for tests.

This medicine does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex and do not share needles.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your lips, tongue or throat, trouble breathing).

Serious (Report these to your healthcare provider right away.): Serious rash with a fever; blistering; mouth sores; red eyes; swelling; unusual muscle pain or joint pain; feeling cold, especially in your arms or legs; decreased urination; pain when urinating; dark urine; yellowing of your eyes or skin; light-colored bowel movements; unexplained loss of appetite; fever; unusual tiredness or weakness; trouble breathing; severe dizziness or fainting; severe stomach pain; severe nausea or vomiting; severe diarrhea; fast or irregular heartbeat; depression or other mood changes.

Other: Numbness or pain in arms or legs, indigestion, mild stomach pain, gas, mild diarrhea, mild nausea, trouble sleeping, mild dizziness, drowsiness, abnormal dreams, headache, changes in body fat, skin discoloration of the hands or feet, back pain, nervousness, runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Allergy, cold, or cough medicines that contain dextromethorphan (Delsym, Mucinex, Robitussin DM)
• Alosetron (Lotronex)
• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Antacids that contain aluminum, calcium, or magnesium, such as Gaviscon, Maalox, Mylanta, Phillips' Chewable Tablets, Rolaids, or TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clorazepate (Gen-Xene, Tranxene), diazepam (Valium), and midazolam (Versed)
• Antibiotics such as amikacin, azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gentamicin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), tobramycin, and vancomycin (Vancocin)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vilazodone (Viibryd)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ethosuximide (Zarontin), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as abiraterone (Zytiga), axitinib (Inlyta), bosutinib (Bosulif), crizotinib (Xalkori), dasatinib (Sprycel), docetaxel (Docefrez, Taxotere), doxorubicin (Doxil), enzalutamide (Xtandi), erlotinib (Tarceva), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), paclitaxel (Abraxane, Taxol), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), vemurafenib (Zelboraf), and vincristine (Marqibo)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Clonazepam (Klonopin)
• Colchicine (Colcrys)
• Dapsone
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as nateglinide (Starlix), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Heart medicines such as amiodarone (Cordarone, Pacerone), carvedilol (Coreg), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, metoprolol (Lopressor, Toprol), mexiletine, procainamide, propafenone (Rythmol), quinidine, and ranolazine (Ranexa)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Ledipasvir/sofosbuvir (Harvoni)
• Lidocaine (Lidoderm, Xylocaine)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, and mefloquine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet) and ranitidine (Zantac)
• Medicines to treat breathing or lung problems such as budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), and salmeterol (Serevent)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), dabigatran (Pradaxa), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), sildenafil (Revatio), and tadalafil (Adcirca)
• Methylergonovine
• Midazolam (Versed)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Natural remedies such as red yeast rice and St. John’s wort
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other antiviral medicines such as abacavir/dolutegravir/lamivudine (Triumeq), abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), acyclovir (Zovirax), adefovir (Hepsera), atazanavir (Reyataz), atazanavir/cobicistat (Evotaz), cidofovir (Vistide), cobicistat (Tybost), darunavir (Prezista), darunavir/cobicistat (Prezcobix), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir (Vitekta), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), emtricitabine/tenofovir (Truvada), etravirine (Intelence), fosamprenavir (Lexiva), ganciclovir (Cytovene), indinavir (Crixivan), lamivudine (Epivir, Epivir-HBV), lamivudine/zidovudine (Combivir), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), simeprevir (Olysio), stavudine (Zerit), tenofovir (Viread), tipranavir (Aptivus), valacyclovir (Valtrex), valganciclovir (Valcyte), and zidovudine (Retrovir)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as butabarbital (Butisol), estazolam, flurazepam, triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil), atomoxetine (Strattera), and modafinil (Provigil)
• Theophylline
• Timolol

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.