October 10, 2017
Brand Name: Prezcobix
Other Names: DRV/COBI, darunavir ethanolate/cobicistat
Drug Class: Combination Drugs
Prezcobix can cause serious, life-threatening side effects. These include liver problems, severe skin reactions or rash, and kidney problems.
Some people taking Prezcobix have had liver problems. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 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:
Contact your health care provider right away if you have any of the following symptoms that could be signs of severe skin reactions or rash:
When taken with certain other medicines, Prezcobix can cause new or worse kidney problems, including kidney failure. Your health care provider should check your kidneys before you start taking Prezcobix and while you are taking Prezcobix.
While taking Prezcobix, it is important to keep all of your appointments with your health care provider.
Prezcobix is a prescription medicine approved by the U.S. Food and Drug Administration (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 treatment-experienced), as long as they have no drug resistance mutations associated with the HIV medicine 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.
Prezcobix contains the following two different medicines combined in one pill:
Darunavir belongs to a class (group) of HIV drugs called protease inhibitors (PIs). PIs block an HIV enzyme called protease. (An enzyme is a protein 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. Pharmacokinetic enhancers, such as cobicistat, are used in HIV treatment to increase the effectiveness of other HIV medicines. In Prezcobix, cobicistat increases the effectiveness of darunavir.
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.
Before taking Prezcobix, tell your health care provider:
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.)
If you miss a dose 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.
Prezcobix 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 Prezcobix 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:
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 package insert 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 at www.accessdata.fda.gov/scripts/medwatch/.
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.
[Note from TheBody.com: This article was created by AIDSinfo, who last updated it on Oct. 10, 2017. We have cross-posted it with their permission.]
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