Genvoya (as a combination product containing Cobicistat, Elvitegravir, Emtricitabine, Tenofovir)

Name: Genvoya (as a combination product containing Cobicistat, Elvitegravir, Emtricitabine, Tenofovir)

Why is this medication prescribed?

The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in adults and children at least 12 years old who have not been treated with other HIV medications or to replace current medication therapy in certain people already taking HIV medications. The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir is in a class of medications called antivirals. Elvitegravir, emtricitabine, and tenofovir work by decreasing the amount of HIV in the blood. Cobicistat helps to keep elvitegravir in the body longer so that the medication will have a greater effect. Although the combination of elvitegravir, cobicistat, emtricitabine and tenofovir will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting the HIV virus to other people.

What special precautions should I follow?

Before taking elvitegravir, cobicistat, emtricitabine, and tenofovir,

  • tell your doctor and pharmacist if you are allergic to elvitegravir, cobicistat, emtricitabine, or tenofovir, any other medications, or any of the ingredients in elvitegravir, cobicistat, emtricitabine, and tenofovir tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor if you are taking any of the following medications: alfuzosin (Uroxatral); carbamazepine (Carbatrol, Epitol, Tegretol, others), cisapride (Propulsid) (not available in the U.S.); ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, in Cafergot, in Migergot), and methylergonovine (Methergine); lovastatin (Altoprev, Mevacor, in Advicor); lurasidone (Latuda); midazolam (Versed) by mouth; phenobarbital; phenytoin (Dilantin, Phenytek); pimozide (Orap); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); St. John's wort; sildenafil (only Revatio, brand used for lung disease); simvastatin (Simcor, Zocor, in Vytorin); or triazolam (Halcion). Your doctor will probably tell you not to take elvitegravir, cobicistat, emtricitabine, and tenofovir if you are taking one or more of these medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as gentamicin; antifungal medications such as itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); antiviral medications such as acyclovir (Sitavig, Zovirax), adefovir (Hepsera), cidofovir, ganciclovir (Cytovene), valacyclovir (Valtrex), and valganciclovir (Valcyte); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) atorvastatin (Lipitor, in Caduet); benzodiazepines such as clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Diastat, Valium), estazolam, flurazepam, and midazolam given intravenously (into a vein); beta blockers such as metoprolol (Lopressor, Toprol-XL, in Dutoprol) and timolol; bosentan (Tracleer); buspirone; calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Diltzac, Tiazac, others), felodipine (Plendil), nicardipine (Cardene), nifedipine (Adalat CC, Afeditab CR, Procardia), and verapamil (Calan, Covera-HS, in Tarka); clarithromycin (Biaxin, in PrevPac); colchicine (Colcrys, Mitagare, in Col-Probenecid); dexamethasone; ethosuximide (Zarontin), fluticasone (Flonase, Flovent, in Advair); oral contraceptives (birth control pills, patch, vaginal ring, or injectable); medications for depression such as amitriptyline, bupropion (Aplenzin, Forfivo XL, Wellbutrin, Zyban), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Brisdelle, Paxil, Pexeva), and trazodone; other medications for HIV or AIDS including adefovir (Hepsera), cobicistat (Tybost, in Evotaz, in Prezcobix), emtricitabine (Emtriva, in Atripla, in Complera, in Truvada), lamivudine (Epivir, in Combivir, in Epzicom, in Trizivir, others), ritonavir (Norvir, in Kaletra, in Technivie), and tenofovir (Viread, in Atripla, in Complera, in Truvada); medications for irregular heartbeat such as amiodarone (Cordarone, Nexterone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), flecainide, lidocaine (Xylocaine), mexiletine, propafenone (Rythmol), and quinidine (in Nuedexta); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); oxcarbazepine (Oxtellar XR, Trileptal); perphenazine; quetiapine (Seroquel); phosphodiesterase (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra, Staxyn); rifabutin (Mycobutin); rifapentine (Priftin); risperidone (Risperdal); salmeterol (Serevent, in Advair); telithromycin (Ketek); thioridazine; warfarin (Coumadin, Jantoven); and zolpidem (Ambien, Edluar, Intermezzo, Zolpimist). Many other medications may also interact with elvitegravir, cobicistat, emtricitabine, and tenofovir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • if you are taking antacids (Maalox, Mylanta, Tums, others), take them 2 hours before or 2 hours after elvitegravir, cobicistat, emtricitabine, and tenofovir.
  • tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking elvitegravir, cobicistat, emtricitabine, and tenofovir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking elvitegravir, cobicistat, emtricitabine and tenofovir.
  • you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.
  • you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms during your treatment with elvitegravir, cobicistat, emtricitabine, and tenofovir, be sure to tell your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Elvitegravir, cobicistat, emtricitabine, and tenofovir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • difficulty falling asleep or staying asleep
  • unusual dreams
  • nausea
  • diarrhea
  • rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING OR SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty swallowing or breathing
  • decreased urination
  • pain in the arms, hands, feet, or legs

Elvitegravir, cobicistat, emtricitabine, and tenofovir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

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