What are the most important things to know about Prezcobix?
Some people taking Prezcobix may develop liver problems, which can be life-threatening. People who have chronic (HBV) or (HCV) may have an increased risk of developing new or worsening liver problems while taking Prezcobix.
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 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
Contact your health care provider right away if you develop a rash while taking Prezcobix. Stop taking Prezcobix 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
Prezcobix, when taken with tenofovir disoproxil fumarate, can cause new or worsening kidney problems, including kidney failure. 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 Prezcobix 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 Prezcobix, it is important to keep all of your appointments with your health care provider.
What is Prezcobix?
Prezcobix is a prescription medicine approved by the U.S. (FDA) for the treatment of HIV in adults and children who weigh at least 88 lb (40 kg) and meet certain requirements, as determined by a health care provider. Prezcobix is always used in combination with other HIV medicines.
For more information on the use of Prezcobix 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/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 Prezcobix?
Before taking Prezcobix, tell your health care provider:
- If you are allergic to any of the HIV medicines in Prezcobix (darunavir or cobicistat), sulfonamides (), or any other medicines.
- If you have problems, including (HBV) or (HCV).
- If you have problems.
- If you have high blood sugar () or .
- 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 Prezcobix during pregnancy. For more information on the use of Prezcobix 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 breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using -based birth control (such as injections, vaginal rings, , a contraceptive patch, or birth control pills). Prezcobix 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 Prezcobix. 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 (particularly St. John's wort) you are taking or plan to take. Prezcobix may affect the way other medicines or products work, and other medicines or products may affect how Prezcobix works. Taking Prezcobix together with certain medicines or products may cause serious, life-threatening side effects.
How should I take Prezcobix?
Prezcobix comes in tablet form. Each tablet contains:
Take Prezcobix according to your health care provider’s instructions. Do not miss a of Prezcobix, and do not change your dose or stop taking Prezcobix without first talking with your health care provider.
Take Prezcobix by mouth with food.
Always take Prezcobix in combination with other HIV medicines.
If you have taken too much Prezcobix, 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 Prezcobix, see the FDA drug label.
What should I do if I forget a dose?
If you miss a of Prezcobix, 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 Prezcobix cause?
Prezcobix may cause side effects. Some side effects of Prezcobix 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 Prezcobix include:
- and high blood sugar ().
- Changes in body fat ().
- 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 .
- Increased bleeding in 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 Prezcobix. To learn more about possible side effects of Prezcobix, 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 Prezcobix be stored?
- Store Prezcobix at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep Prezcobix in the container that it came in and keep the container tightly closed.
- Do not use Prezcobix if the original seal over the container opening is broken or missing.
- Throw away Prezcobix that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Prezcobix and all medicines out of reach of children.
Where can I find more information about Prezcobix?
- For more information on the use of Prezcobix 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 (film coated). The Patient Package Insert includes information for people taking Prezcobix.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for darunavir and cobicistat available from MedlinePlus.
- Prezcobix-related research studies, from . (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.
Main number: 800-526-7736
Patient assistance: 800-652-6227
Janssen CarePath: 866-836-0114
Last Reviewed: November 27, 2023