Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide oral tablets

What is this medication?

ELVITEGRAVIR; COBICISTAT; EMTRICITABINE; TENOFOVIR ALAFENAMIDE (el vye TEG ra veer; koe BIS i stat; em tri SIT uh bean; te NOE fo veer) is 3 antiretroviral medicines and a medication booster in 1 tablet. It is used to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Genvoya

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• an unusual or allergic reaction to elvitegravir, cobicistat, emtricitabine, tenofovir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• adefovir
• alfuzosin
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cisapride
• irinotecan
• lumacaftor; ivacaftor
• lurasidone
• medicines for cholesterol like lovastatin, simvastatin
• medicines for headaches like dihydroergotamine, ergotamine, methylergonovine
• midazolam
• naloxegol
• other antiviral medicines for HIV or AIDS
• pimozide
• rifampin
• sildenafil
• St. John's wort
• triazolam

This medicine may also interact with the following medications:

• antacids
• atorvastatin
• bosentan
• buprenorphine; naloxone
• certain antibiotics like clarithromycin, telithromycin, rifabutin, rifapentine
• certain medications for anxiety or sleep like buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem
• certain medicines for blood pressure or heart disease like amlodipine, diltiazem, felodipine, metoprolol, nicardipine, nifedipine, timolol, verapamil
• certain medicines for depression, anxiety, or psychiatric disturbances
• certain medicines for erectile dysfunction like avanafil, sildenafil, tadalafil, vardenafil
• certain medicines for fungal infection like itraconazole, ketoconazole, voriconazole
• certain medicines that treat or prevent blood clots like warfarin, apixaban, betrixaban, dabigatran, edoxaban, and rivaroxaban
• colchicine
• cyclosporine
• female hormones, like estrogens and progestins and birth control pills
• medicines for infection like acyclovir, cidofovir, valacyclovir, ganciclovir, valganciclovir
• medicines for irregular heart beat like amiodarone, bepridil, digoxin, disopyramide, dofetilide, flecainide, lidocaine, mexiletine, propafenone, quinidine
• metformin
• oxcarbazepine
• phenothiazines like perphenazine, risperidone, thioridazine
• salmeterol
• sirolimus
• steroid medicines like betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone
• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

If you have hepatitis B, talk to your doctor if you plan to stop this medicine. The symptoms of hepatitis B may get worse if you stop this medicine.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• fast, irregular heartbeat
• muscle pain or weakness
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• headache
• nausea
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.