Cobicistat (koe-BIK-i-stat), Elvitegravir (el-vi-TEG-ra-vir), Emtricitabine (em-trye-SYE-ta-been), Tenofovir Disoproxil Fumarate (ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s):

Stribild

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine with food or milk.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even for a short time, the virus may become resistant to the medicine and harder to treat. Contact your doctor or pharmacist when your supply is running low. Do not allow yourself to run out of medicine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not use this medicine if the seal on the bottle is broken or missing.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use medicine for heart rhythm problems (such as amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine, Cordarone, Lanoxin, Norpace, Tambocor), certain antibiotics or medicine to treat fungal infections (such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Biaxin, Nizoral), or a blood thinner (such as warfarin, Coumadin, Jantoven). Tell your doctor if you also use medicine for seizures (such as carbamazepine, clonazepam, ethosuximide, oxcarbazepine, phenobarbital, phenytoin, Dilantin, Tegretol), medicine for depression (such as amitriptyline, bupropion, desipramine, imipramine, nortriptyline, paroxetine, trazodone, Elavil, Wellbutrin), or medicine for mental illness (such as perphenazine, risperidone, thioridazine, Mellaril).
• Tell your doctor if you also use atorvastatin (Lipitor), bosentan (Tracleer), colchicine (Colcrys), cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone (Decadron), fluticasone (Flonase), rifabutin (Mycobutin), rifapentine (Priftin), salmeterol (Serevent), sirolimus (Rapamune), tacrolimus (Prograf), certain blood pressure medicines (such as amlodipine, diltiazem, felodipine, nicardipine, nifedipine, metoprolol, timolol, verapamil, Lotrel, Norvasc, Toprol), medicine for anxiety and sleeping (such as buspirone, clorazepate, diazepam, estazolam, flurazepam, injectable midazolam, zolpidem, Valium), an estrogen hormone replacement or birth control pill (such as ethinyl estradiol, norgestimate, Estinyl, Ortho-Cyclen, Ortho Tri-Cyclen), medicine to treat erection problems (such as sildenafil, tadalafil, vardenafil, Cialis, Levitra, Viagra), or medicine to treat high blood pressure in your lungs (such as tadalafil, Adcirca).
• If you take antacids that contain aluminum or magnesium (such as Maalox, Mylanta, Tums), do not take them at the same time that you take this medicine. Take these medicines at least 2 hours before or after you take Stribild?.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or if you have kidney problems, liver disease (including hepatitis B), or bone problems.
• You should not breastfeed if you have HIV or AIDS, because you might give the infection to your baby through your breast milk.
• Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These reactions are more common if you are female, obese, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have stomach pain, nausea, vomiting, decreased appetite, muscle pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.
• This medicine may weaken your bones and increase your risk for broken bones. Talk to your doctor about this if you have any concerns.
• This medicine may cause changes in your body fat. Tell your doctor if you notice changes in your body shape, such as more fat in your upper back and neck or around your chest and stomach area. You might also lose fat from your legs, arms, and face.
• Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (such as Graves disease, polymyositis, and Guillain-Barr syndrome) may also occur.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, cloudy urine
• Dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, yellow skin or eyes
• Lightheadedness or fainting
• Rapid breathing, trouble breathing
• Rapid weight gain, swelling of your face, ankles, legs, or feet
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, mild nausea
• Weight gain around your neck, upper back, breast, or waist, moon-shaped face

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088