Cobicistat (koe-BIK-i-stat), Elvitegravir (el-vi-TEG-ra-vir), Emtricitabine (em-trye-SYE-ta-been), Tenofovir Alafenamide (ten-OF-oh-vir al-a-FEN-a-mide)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Genvoya

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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 harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the bottle tightly closed. Keep the medicine in the original bottle.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with alfuzosin, carbamazepine, dihydroergotamine, ergotamine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, phenobarbital, phenytoin, pimozide, rifampin, sildenafil, simvastatin, triazolam, or St John's wort.
• There are many drugs that can interact with this medicine. Make sure your doctor knows about all other medicines you are using, especially the following:
  • Atorvastatin, bosentan, buspirone, clorazepate, colchicine, clopidogrel, cyclosporine, diazepam, estazolam, flurazepam, rifabutin, rifapentine, salmeterol, sirolimus, tacrolimus, tadalafil, ticagrelor, vardenafil, zolpidem
  • Birth control pills (including drospirenone/ethinyl estradiol, levonorgestrel, norgestimate/ethinyl estradiol
  • Blood pressure medicine (including beta blockers, calcium channel blockers)
  • Medicine for depression or mental health problems (including perphenazine, quetiapine, risperidone, thioridazine, trazodone, SSRIs, TCAs)
  • Blood thinners (including apixaban, betrixaban, dabigatran, edoxaban, rivaroxaban, warfarin)
  • Medicine for heart rhythm problems (including amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine)
  • Medicine to treat an infection (including acyclovir, cidofovir, clarithromycin, ganciclovir, gentamicin, itraconazole, ketoconazole, telithromycin, valacyclovir, valganciclovir, voriconazole)
  • Medicine to treat seizures (including ethosuximide, oxcarbazepine)
  • Narcotic pain medicine (including buprenorphine/naloxone, fentanyl, tramadol)
  • NSAIDs
  • Steroid medicine (including betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, prednisone, triamcinolone)
• If you are taking antacids or laxatives containing aluminum, calcium, or magnesium, sucralfate, calcium or iron supplements, or buffered medicines, take them at least 2 hours before or after you take this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney problems or liver disease (including hepatitis B).
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Lactic acidosis (too much acid in the blood)
  • Severe liver problems
  • Worsening of hepatitis B infection (if the medicine is stopped)
  • Kidney problems
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast breathing, trouble breathing, lightheadedness, severe weakness, tiredness, confusion

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

• Diarrhea
• Headache

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