Drug information

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Brand Name:
Symtuza
Other Names:
DRV/COBI/FTC/TAF, darunavir ethanolate/cobicistat/emtricitabine/tenofovir AF, darunavir ethanolate/cobicistat/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir AF, darunavir/cobicistat/emtricitabine/tenofovir alafenamide fumarate
Drug Class:
Combination Drugs
Protease Inhibitor (darunavir)
Nucleoside Reverse Transcriptase Inhibitor (emtricitabine, tenofovir alafenamide)
Pharmacokinetic Enhancer (cobicistat)
Drug Image(s): (Click to enlarge)
 
What are the most important things to know about Symtuza?What are the most important things to know about Symtuza?

What are the most important things to know about Symtuza?

Symtuza can cause serious, life-threatening side effects. These include severe skin rash and allergic reactions, a buildup of lactic acid in the blood (lactic acidosis), liver problems, new or worsening kidney problems, including kidney failure, and drug interactions.

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
  • 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, or throat
  • Trouble breathing or swallowing
Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
  • 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
  • Fast or abnormal heartbeat

Some people taking Symtuza have had 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 problems have also occurred in people taking Symtuza who have no history of liver disease.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • 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
  • Itching

If you have both HIV and HBV infection and take Symtuza, your HBV infection may get much worse (flare-up) if you stop taking Symtuza. Do not stop taking Symtuza without first talking with your health care provider.

Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called Fanconi Syndrome), which may be related to tenofovir-containing drugs:

  • Bone pain that does not go away or gets worse
  • Pain in your arms, hands, legs, or feet
  • Broken bones
  • Muscle pain or weakness

Taking Symtuza with certain other medicines may cause serious, life-threatening side effects. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While taking Symtuza, it is important to keep all of your appointments with your health care provider.

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 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 Living 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?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), sulfonamide (sulfa) medicines, or any other medicines.
  • If you have liver problems, including HBV or HCV infection.
  • 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 in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
  • If you are breastfeeding or plan to breastfeed. For women with HIV in the United States, the Guideline does not recommend breastfeeding. Before your baby is born, or if you are already breastfeeding, talk to your health care provider to discuss alternative options for feeding your baby.
  • 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?How should I take Symtuza?

How should I take Symtuza?

Symtuza comes in tablet form. Each tablet contains:

Take Symtuza according to your health care provider’s instructions.

Take Symtuza by mouth once a day 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) 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. 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.

Other possible side effects of Symtuza include:

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?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. 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?

Manufacturer Information

Janssen

Main number: 800-526-7736
Patient assistance: 800-652-6227
Janssen CarePath: 866-836-0114

 

Last Reviewed: September 8, 2021