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Darunavir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

Darunavir / Cobicistat / Emtricitabine / Tenofovir Alafenamide

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
WARNING:

WARNING:

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

Contact your health care provider right away if you have any of the following symptoms that could be signs of severe or life-threatening skin reactions or rash: 

  • Fever
  • Tiredness
  • Muscle or joint pain
  • Blisters or skin lesions
  • Mouth sores or ulcers
  • Red or inflamed eyes, such as pink eye (conjunctivitis)

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
  • Trouble breathing
  • Stomach pain with nausea or vomiting
  • Feeling cold, especially in your hands and feet
  • Dizziness or lightheadedness
  • Fast or irregular heartbeat

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 or tenderness on the right side or your stomach area (abdominal pain)

Symtuza is not approved for the treatment of chronic hepatitis B virus infection (HBV). 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. To help avoid this, take Symtuza exactly as prescribed. Do not run out of Symtuza or stop taking Symtuza without talking to your health care provider.

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

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:

  • who have never taken HIV medicines before, or
  • who have a viral load less than 50 copies per mL, have been on a stable treatment regimen for at least 6 months, and have no known substitutions associated with resistance to darunavir or tenofovir.

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

Symtuza contains the following 4 different medicines combined in one pill:

PIs block an HIV enzyme, a type of protein, called protease. By blocking protease, PIs prevent HIV from multiplying and can reduce the amount of HIV in the body. Pharmacokinetic enhancers, such as cobicistat, are used in HIV treatment to increase the effectiveness of other HIV medicines. In Symtuza, cobicistat increases the effectiveness of darunavir.

Emtricitabine and tenofovir alafenamide are NRTIs. NRTIs block an HIV enzyme, a type of protein, called reverse transcriptase. By blocking reverse transcriptase, the two drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.

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) or any other medicines.
  • If you have liver problems, including HBV infection or HCV infection
  • If you have kidney problems
  • If you are allergic to sulfa (sulfonamide)
  • If you have diabetes
  • If you have hemophilia
  • If you have any other medical conditions
  • If you are pregnant or plan to become pregnant. Whether Symtuza can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking Symtuza when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Symtuza.
  • 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 AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products 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.

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.

Do not change your dose or stop taking Symtuza without talking to your health care provider.

Take Symtuza one time 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 take 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?

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?

Symtuza may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Symtuza can be serious. Serious side effects of Symtuza include severe or life-threatening skin reactions or rash, a buildup of lactic acid in the blood (lactic acidosis), and severe liver problems (See the WARNING box above). Other possible side effects of Symtuza include:

  • 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.
  • New or worse kidney problems, including kidney failure.
  • Diabetes and high blood sugar (hyperglycemia).
  • Changes in body fat, including gain or loss of fat.
  • Increased bleeding for hemophiliacs.

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 MedWatch at 1-800-FDA-1088 (1-800-332-1088) or online.

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?

More information about Symtuza is available:

Manufacturer Information

Janssen

Main number: 800-526-7736
Patient assistance: 800-652-6227

The above Patient Version drug summary is based on the following FDA label(s): Tablet.

Last Reviewed: July 19, 2018

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