Drug Database: Darunavir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

What is Symtuza?What is Symtuza?

What is Symtuza?

Symtuza is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV 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. Do not take Symtuza with other HIV medicines unless your health care provider has prescribed it for use 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, but using HIV medicines as directed by a health care provider helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are using HIV medicines, do not cut down on, skip, or stop using them unless your health care provider tells you to. For more information about using your HIV medicines as prescribed and ways to overcome barriers to medication adherence, please read the HIVinfo fact sheet on HIV Treatment Adherence.

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

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 breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• If you are using hormone-based birth control (such as injections, vaginal rings, implants, contraceptive patches, or birth control pills). 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.

How should I take Symtuza?How should I take Symtuza?

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. While taking Symtuza, it is important to keep all your appointments 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.

Do not take Symtuza with other HIV medicines unless your health care provider has prescribed it for use with other HIV medicines.

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?What should I do if I forget a dose?

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?What side effects can Symtuza cause?

What side effects can Symtuza cause?

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

Important warning:

• Worsening of hepatitis B virus infection (HBV). Your health care provider will test you for HBV before you start treatment with Symtuza. If you have both HIV and HBV and take Symtuza, your HBV may get worse (flare-up) if you stop taking Symtuza. Do not stop taking Symtuza without first talking with your health care provider. If you stop taking Symtuza, you will need blood tests regularly for several months to check your liver function and monitor your HBV.

Other possible serious side effects:

• 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.
• Liver problems. Some people taking Symtuza may develop liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Symtuza. Liver function tests may be done before and during treatment with Symtuza. Contact your health care provider right away if you have any of the following symptoms: yellowing of your skin or the whites of your eyes (jaundice); dark-colored urine; light-colored bowel movements; loss of appetite for several days or longer; nausea or vomiting; pain, aching, or tenderness on the right side of your stomach/abdominal area; or itching.
• New or worsening kidney problems, including kidney failure. Your health care provider will do blood and urine tests before and during treatment with Symtuza to check your kidneys.
• Skin rash and allergic reactions. Mild rash can be common with Symtuza and usually goes away on its own. In rare cases, rashes may be severe. Contact your health care provider right away if you develop a rash while taking Symtuza. Stop taking Symtuza and get medical help right away if you develop a rash with any of the following symptoms: general ill feeling (malaise); extreme tiredness; muscle or joint aches; fever; blistering or peeling skin; blisters or sores in your mouth; redness or swelling of the eyes (conjunctivitis); swelling of your face, lips, mouth, tongue, throat, or lymph nodes; or trouble breathing or swallowing.
• Changes in body fat (lipodystrophy syndrome).
• Diabetes and high blood sugar (hyperglycemia). Rarely, some people taking Symtuza may get high blood sugar, develop diabetes, or have worsening diabetes. Let your health care provider know if you have increased thirst or if you urinate more frequently while taking Symtuza.
• Increased bleeding for people with hemophilia.
• A buildup of lactic acid in the blood (lactic acidosis). Lactic acidosis is a serious but very uncommon occurrence. Contact your health care provider right away if you have any of the following symptoms: unusual weakness or tiredness; unusual muscle pain; shortness of breath or fast breathing; stomach pain with nausea and vomiting; cold or blue hands and feet; dizziness or lightheadedness; or fast or abnormal heartbeat.
• Lactic acidosis may also lead to severe liver problems. In rare cases, severe liver problems associated with lactic acidosis may occur. Contact your health care provider right away if you develop any of the symptoms of liver problems listed above.

Tell your health care provider if you have any side effects that bother you or that do 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.

What medicines can interact with Symtuza?What medicines can interact with Symtuza?

What medicines can interact with Symtuza?

HIV medicines may interact with other medicines and supplements. Before starting Symtuza, tell your health care provider about all the 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.

For a list of medicines that may interact with Symtuza, see the drug label or ask your health care provider or pharmacist. You can also look up potential interactions between your HIV medicines and other drugs using the HIV Drug Interaction Checker online.

How should Symtuza be stored?How should Symtuza be stored?

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. Do not eat the desiccant. 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?Where can I find more information about Symtuza?

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 alafenamide 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.)
• A list of FDA-approved HIV medicines, from HIVinfo.