Cobicistat, darunavir, emtricitabine, and tenofovir (Symtuza) is a combination medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). cobicistat, darunavir, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Symtuza is for use in adults and children weighing at least 88 pounds (40 kilograms).

Symtuza is sometimes used in people who have never been treated with other HIV medications.

Symtuza is also used to replace other HIV medications in adults with suppressed viral loads. Your doctor will determine which medication is best for you.

Symtuza may also be used for purposes not listed in this medication guide.

Tell your doctor about all your other medicines. Some drugs should not be used with Symtuza.

Call your doctor at once if you have signs of a serious side effect--upper stomach pain, loss of appetite, vomiting, dark urine, clay-colored stools, yellowing of your skin or eyes, fever, tiredness, eye redness, muscle or joint pain, skin sores, or a skin rash with blistering.

If you've had hepatitis B, it may come back or get worse after you stop using cobicistat, darunavir, emtricitabine, and tenofovir. You may need liver function tests for several months.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take with food.

If you cannot swallow a tablet whole, you may break the tablet in half. Take both halves right away.

You will need frequent medical tests.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Skipping doses could make your virus resistant to medication. Remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

If you've had hepatitis B, it may come back or get worse after you stop using Symtuza. You may need liver function tests while using cobicistat, darunavir, emtricitabine, and tenofovir and for several months after you stop.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Comments:
-This drug is not recommended during pregnancy due to considerably lower exposures of darunavir and cobicistat during the second and third trimesters.
-This drug should not be started in pregnant women; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment history or in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months who have no known substitutions associated with resistance to darunavir or tenofovir

Usual Pediatric Dose for HIV Infection:

At least 40 kg: 1 tablet orally once a day

Comments:
-This drug is not recommended during pregnancy due to considerably lower exposures of darunavir and cobicistat during the second and third trimesters.
-This drug should not be started in pregnant women; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no prior antiretroviral treatment history or in patients virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months who have no known substitutions associated with resistance to darunavir or tenofovir

Some drugs should not be used with Symtuza. Your treatment plan may change if you also use:

• alfuzosin;

• cisapride;

• colchicine (in people with liver or kidney disease);

• elbasvir and grazoprevir;

• lovastatin or simvastatin;

• pimozide, lurasidone;

• rifampin;

• sildenafil (Revatio, for pulmonary arterial hypertension);

• St. John's wort;

• triazolam or oral midazolam;

• heart medication--dronedarone, ivabradine, ranolazine;

• ergot medicines--dihydroergotamine, ergotamine, methylergonovine; or

• seizure medicine--carbamazepine, phenytoin, phenobarbital.

Tell your doctor if you have ever had:

• liver disease (especially cirrhosis, or hepatitis B or C);

• kidney disease;

• diabetes;

• an allergy to sulfa drugs; or

• a bleeding disorder such as hemophilia.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.

Symtuza may not work as well if you take it during pregnancy. Do not start taking this medicine if you are pregnant, and tell your doctor if you become pregnant.

If you plan to get pregnant, ask your doctor for another antiviral medicine to use during pregnancy. To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

If you do not plan to get pregnant, ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy. Symtuza can increase certain side effects when taken with hormonal birth control (pills, injections, implants, skin patches, vaginal rings).

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using cobicistat, darunavir, emtricitabine, and tenofovir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Cobicistat, darunavir, emtricitabine, and tenofovir may cause serious side effects. Call your doctor at once if you have:

• increased thirst, increased urination;

• kidney problems--swelling, urinating less, feeling tired or short of breath;

• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or

• liver problems--nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Symtuza can affect your immune system (even weeks or months after you've used this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of cobicistat, darunavir, emtricitabine, and tenofovir may include:

• nausea, upset stomach, diarrhea, gas;

• headache, feeling tired; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect Symtuza, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.