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:
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.
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 by less than 12 hours, take your missed dose right away. Then take your next dose of Prezcobix at your regularly scheduled time.
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.
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:
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.
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/.
More information about Prezcobix is available:
Janssen Pharmaceuticals, Inc.
Last Reviewed: October 6, 2016