What are the most important things to know about Symtuza?
Symtuza can cause serious, life-threatening side effects. These include severe or life-threatening skin reactions or rash, a buildup ofin the blood ( ), and severe problems.
Contact your health care provider right away if you develop any skin changes along with any of the following symptoms:
- Muscle or joint pain
- Blisters or skin lesions
- Mouth sores or ulcers
- Redness or swelling of the eyes ( )
- Weakness or tiredness
- Unusual muscle pain
- Trouble breathing
- Stomach pain with nausea and vomiting
- Feeling cold, especially in your hands and feet
- Dizziness or lightheadedness
- Fast or abnormal heartbeat
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea, vomiting, or pain in your stomach area (abdominal pain)
Symtuza is not approved for the treatment of chronic(HBV). If you have both HIV and HBV 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?
Symtuza is a prescription medicine approved by the U.S.(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 HIVSymtuza contains four different medicines: and should not be used with other HIV medicines.darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
HIV medicines can’t 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 . If you are taking HIV medicines, don’t 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) or any other medicines.
- If you have liver problems, including HBV or (HCV).
- If you have kidney problems.
- If you are allergic to sulfa (sulfonamide).
- If you have .
- If you have .
- 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.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Symtuza.
- If you are using HIV and Birth Control infographic. -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
- 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 (brand name: Prezista)
- 150 mg cobicistat (brand name: Tybost)
- 200 mg emtricitabine (brand name: Emtriva)
- 10 mg tenofovir alafenamide
Take Symtuza according to your health care provider’s instructions.
Do not change youror stop taking Symtuza without talking to your health care provider.
Take Symtuza 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 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?
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. 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.
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.Other possible side effects of Symtuza include:
- Changes in your (called 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 ( ).
- 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 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?
More information about Symtuza is available:
Main number: 800-526-7736
Patient assistance: 800-652-6227
Janssen CarePath: 866-836-0114
The above Patient Version drug summary is based on the following FDA label(s): Tablet.
Last Reviewed: July 23, 2020