Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir 

(el'' vi teg' ra vir) (koe bik' i stat)

(em'' trye sye' ta been) (ten of' oh vir)

IMPORTANT WARNING:

Taking elvitegravir, cobicistat, emtricitabine, and tenofovir may cause life-threatening damage to the liver and a potentially life-threatening condition called lactic acidosis (buildup of lactic acid in the blood). Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: nausea; vomiting; pain in the upper right part of your stomach; loss of appetite; flu-like symptoms; extreme tiredness; unusual bleeding or bruising; weakness; dizziness; lightheadedness; fast or irregular heartbeat; trouble breathing; dark yellow or brown urine; light-colored bowel movements; yellowing of the skin or eyes; feeling cold, especially in the arms or legs; or muscle pain that is different than any muscle pain you usually experience.

Elvitegravir, cobicistat, emtricitabine, and tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with elvitegravir, cobicistat, emtricitabine, and tenofovir. If you have HBV and you take elvitegravir, cobicistat, emtricitabine, and tenofovir, your condition may suddenly worsen when you stop taking this medication. Your doctor will examine you and order lab tests regularly for several months after you stop taking this medication to see if your HBV has worsened.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to elvitegravir, cobicistat, emtricitabine, and tenofovir.

Talk to your doctor about the risks of taking elvitegravir, cobicistat, emtricitabine, and tenofovir.

WHY is this medicine prescribed?

The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir is used to treat HIV in patients who have not been treated with other medications. 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 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.

HOW should this medicine be used?

The combination of elvitegravir, cobicistat, emtricitabine, and tenofovir comes as a tablet to take by mouth. It is usually taken with food once a day. Take elvitegravir, cobicistat, emtricitabine, and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take elvitegravir, cobicistat, emtricitabine, and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take elvitegravir, cobicistat, emtricitabine, and tenofovir even if you feel well. Do not stop taking elvitegravir, cobicistat, emtricitabine, and tenofovir without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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); 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); midazolam (Versed) by mouth; pimozide (Orap); rifampin (Rimactane, Rifadin, 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: antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); antiviral medications such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), ganciclovir (Cytovene, Vitasert), valacyclovir (Valtrex), and valganciclovir (Valcyte); atorvastatin (Lipitor, in Caduet); benzodiazepines such as clorazepate (ClorazeCaps, Tranxene, others), diazepam (Valium), estazolam, flurazepam (Dalmane), and midazolam given intravenously (into a vein); beta blockers such as metoprolol (Lopressor) and timolol (Blocadren); bosentan (Tracleer); buspirone; calcium channel blockers such as amlodipine (Norvasc, in Caduet and Lotrel), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil, in Lexxel), nicardipine (Cardene), nifedipine (Adalat, Procardia), and verapamil (Calan, Covera, Isoptin, others); clarithromycin (Biaxin, in PrevPac); colchicine (Colcrys, in Colbenemid); dexamethasone (Decadron, Dexpak, in Neudexta); fluticasone (Flonase, Flovent, in Advair); oral contraceptives (birth control pills); medications for depression such as amitriptyline (Elavil), bupropion (Budeprion, Wellbutrin, Zyban, others), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil, Pexeva), and trazodone; other medications for HIV or AIDS including emtricitabine (Emtriva, in Atripla, in Complera, in Truvada), lamivudine (Epivir, in Combivir, in Epzicom, in Trizivir), ritonavir (Norvir, in Kaletra), and tenofovir (Viread, in Atripla, in Complera, in Truvada); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), flecainide (Tambocor), lidocaine (Xylocaine), mexiletine (Mexitil), propafenone (Rythmol), and quinidine (in Neudexta); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others), clonazepam (Klonopin), ethosuximide (Zarontin), oxcarbazepine (Trileptal), phenobarbital (Luminal), and phenytoin (Dilantin, Phenytek); medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf); perphenazine; certain phosphodiesterase (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra); 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, bone problems, 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 breast-feeding. If you become pregnant while taking elvitegravir, cobicistat, emtricitabine, and tenofovir, call your doctor. You should not breast-feed 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 at anytime 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 should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine 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
  • diarrhea

• rash

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, 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
  • bone pain

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 [at 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of 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.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names
  • Stribild® (as a combination product containing Cobicistat, Elvitegravir, Emtricitabine, Tenofovir)

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