Darunavir / CobicistatBrand Name: Prezcobix Other Names: DRV/COBI, darunavir ethanolate/cobicistat Drug Class: Combination Drugs
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Prezcobix can cause serious, life-threatening side effects. These includeproblems, severe skin reactions or rash, and kidney problems.
Some people taking Prezcobix have had liver problems. People with a history ofB (HBV) or hepatitis C virus (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking Prezcobix. Liver function tests may be done before and during treatment with Prezcobix.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Dark-colored urine.
- Pale-colored bowel movements.
- Yellowing of your skin or whites of your eyes ( ).
- Pain or tenderness on your right side below your ribs.
- Loss of appetite.
- Muscle or joint pain.
- Mouth sores or ulcers.
- (redness or swelling of the eyes).
- Blisters or skin lesions.
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. darunavir (brand name: Prezista). (Drug resistance mutations are changes in the genetic material of HIV that cause the virus to become insensitive to certain HIV medicines.) Talk to your health care provider if you have taken darunavir in the past or are currently taking darunavir. Prezcobix is always used in combination with other HIV medicines.(FDA) for the treatment of HIV infection in adults. Prezcobix can be taken by adults who have never taken HIV medicines before (called treatment-naive) and adults who have taken HIV medicines before (called ), as long as they have no mutations associated with the HIV medicine
Prezcobix contains the following two different medicines combined in one pill:
- Darunavir – an HIV medicine called a (PI).
- Cobicistat – an HIV medicine called a pharmacokinetic enhancer (CYP3A inhibitor).
Darunavir belongs to a class (group) of HIV drugs called protease inhibitors (PIs). PIs block an HIV called protease. (An enzyme is a that starts or increases the speed of a chemical reaction.) By blocking protease, PIs prevent HIV from multiplying and can reduce the amount of HIV in the body. , such as cobicistat, are used in HIV treatment to increase the effectiveness of other HIV medicines.
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 .
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 (cobicistat or darunavir) or any other medicines.
- If you have liver problems, including hepatitis B virus (HBV) infection or .
- 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. Whether Prezcobix can harm an unborn baby is unknown. Prezcobix should be used during pregnancy only if the potential benefits outweigh the risks. Talk to your health care provider about possible risks with taking Prezcobix when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking Prezcobix.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). When taking Prezcobix, additional or alternative (non-hormonal) forms of birth control should be used. 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 AIDSinfo
- 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.
Take Prezcobix once a day with food.
Always take Prezcobix in combination with other HIV medicines.
If you take too much Prezcobix, 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 Prezcobix, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?
If you miss a
If you miss a dose of Prezcobix by more than 12 hours, wait and then take the next dose at your regularly scheduled time.
If you skip a dose of Prezcobix, do not double the next dose. Do not take more or less than your prescribed dose of Prezcobix at any one time.
What side effects can Prezcobix cause?
Prezcobix may cause side effects. Most side effects from Prezcobix are manageable, but a few can be serious. Serious side effects of Prezcobix include liver problems, severe skin reactions or rash, and kidney problems. (See the WARNING box above.)
Other possible side effects of Prezcobix include:
- and high blood sugar ( ).
- Changes in body fat (including gain or loss of fat).
- (IRIS), a condition that sometimes occurs when the 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.
- Increased bleeding in people with hemophilia.
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 oror talk to your health care provider or pharmacist.
The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to Prezcobix.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.
How should Prezcobix be stored?
- Store Prezcobix at room temperature, 68°F to 77°F (20°C to 25°C).
- 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?
More information about Prezcobix is available:
Janssen Pharmaceuticals, Inc.
The above Patient Version drug summary is based on the following FDA label(s): Tablet, film coated.
Last Reviewed: October 6, 2016