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 ofin the blood ( ), problems, new or worsening kidney problems, including kidney failure, and .
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
- Blistering or peeling skin
- Blisters or sores in your mouth
- Redness or swelling of the eyes ( )
- Swelling of your face, lips, mouth, tongue, or throat
- Trouble breathing or swallowing
- 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(HBV) or (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 ( )
- 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
If you have both HIV and HBVand 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), 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?
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 HIVand should not be used with other HIV medicines.
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. 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), 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 .
- 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. 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 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:
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?
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.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.
- Diabetes and high blood sugar ( ).
- Changes in body fat ( ).
- Increased bleeding for people with .
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?
- 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.
- This Patient Version drug summary is based on the following FDA label(s): Tablet. The Patient Counseling Information section of the label includes information for people taking Symtuza.
- Symtuza-related research studies, from .
- A list of FDA-approved HIV medicines, from HIVinfo.
Main number: 800-526-7736
Patient assistance: 800-652-6227
Janssen CarePath: 866-836-0114
Last Reviewed: September 8, 2021