Drug Database: Darunavir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

What is Symtuza?

Symtuza is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children weighing at least 88 lb (40 kg) who have never taken HIV medicines before or who meet certain requirements, as determined by a health care provider.

Symtuza is a complete HIV treatment regimen and should not be used with other HIV medicines.

Symtuza contains four different medicines: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.

For more information on the use of Symtuza in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

What should I tell my health care provider before taking Symtuza?

Before taking Symtuza, tell your health care provider:

• If you are allergic to any of the HIV medicines in Symtuza (darunavir, cobicistat, emtricitabine, or tenofovir alafenamide), sulfa medicines (sulfonamides), or any other medicines.
• If you have liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have kidney problems.
• If you have diabetes.
• If you have hemophilia.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Symtuza during pregnancy. For more information on the use of Symtuza during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Symtuza may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking Symtuza. For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John’s wort) you are taking or plan to take. Symtuza may affect the way other medicines or products work, and other medicines or products may affect how Symtuza works. Taking Symtuza together with certain medicines or products may cause serious side effects.

How should I take Symtuza?

Symtuza comes in tablet form. Each tablet contains:

• 800 mg darunavir 
• 150 mg cobicistat
• 200 mg emtricitabine
• 10 mg tenofovir alafenamide

Take Symtuza according to your health care provider’s instructions. Do not miss a dose of Symtuza, and do not change your dose or stop taking Symtuza without first talking with your health care provider.

Take Symtuza by mouth and with food.

If you have difficulty swallowing, the tablet may be split using a tablet cutter. After splitting the tablet, the entire dose (both halves) should be taken right away.

If you have taken too much Symtuza, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.

For more information on how to take Symtuza, see the FDA drug label.

What should I do if I forget a dose?

If you miss a dose of Symtuza, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can Symtuza cause?

Symtuza may cause side effects. Some side effects of Symtuza can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Diabetes and high blood sugar (hyperglycemia).
• Changes in body fat (lipodystrophy syndrome).
• Increased bleeding for people with hemophilia.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Symtuza. To learn more about possible side effects of Symtuza, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should Symtuza be stored?

• Store Symtuza at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep Symtuza in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
• Do not use Symtuza if the original seal over the container opening is broken or missing.
• Throw away Symtuza that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Symtuza and all medicines out of reach of children.

Where can I find more information about Symtuza?

• For more information on the use of Symtuza in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
• This Patient Version drug summary is based on the following FDA label(s): Tablet. The Patient Package Insert includes information for people taking Symtuza.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for darunavir, cobicistat, emtricitabine, and tenofovir available from MedlinePlus.
• Symtuza-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
• A list of FDA-approved HIV medicines, from HIVinfo.