February 5, 2015
Brand Name: Prezista
Other Name(s): darunavir ethanolate, DRV
Drug Class: Protease Inhibitors
Approved Use: Treatment of HIV Infection
Darunavir can cause serious, life-threatening side effects. These include liver problems and severe skin reactions or rash.
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 develop a rash. Stop taking darunavir (and ritonavir, the HIV medicine always used with darunavir) and contact your health care provider immediately if you develop any skin changes along with the following symptoms:
Taking darunavir with certain other medicines may cause serious side effects.
While taking darunavir, it is important to keep all of your appointments with your health care provider.
Darunavir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 3 years of age and older. Darunavir is always used in combination with the HIV medicine ritonavir (brand name: Norvir) and other HIV medicines.
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.
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 darunavir, tell your health care provider:
Darunavir comes in the following forms and strengths:
Take darunavir according to your health care provider's instructions. If your child is prescribed darunavir, follow the instructions given to you by your health care provider for using the drug.
Always take darunavir in combination with the HIV medicine ritonavir (brand name: Norvir) and other HIV medicines.
Take darunavir and ritonavir at the same time with food. Swallow darunavir tablets whole with a drink.
Take (or give) darunavir oral suspension with the oral dosing syringe that comes with the medicine. See the instructions that come with darunavir oral suspension for information about the right way to prepare and take a dose. Shake the oral suspension well before each use.
If your or your child's prescribed dose of darunavir oral suspension is more than 6 mL, you will need to divide the dose. Follow the instructions given to you by your health care provider or pharmacist about how to divide the dose. Ask your health care provider or pharmacist if you are not sure how to do this.
If you take too much darunavir, 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 darunavir, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
For people who take darunavir one time a day: If you miss a dose by less than 12 hours, take your missed dose of darunavir right away. Then take your next dose at your regularly scheduled time. If you miss a dose by more than 12 hours, wait and then take the next dose at your regularly scheduled time.
For people who take darunavir two times a day: If you miss a dose by less than 6 hours, take your missed dose of darunavir right away. Then take your next dose at your regularly scheduled time. If you miss a dose by more than 6 hours, wait and then take the next dose at your regularly scheduled time.
Do not take two doses at the same time to make up for a missed dose.
Darunavir can cause serious, life-threatening side effects. These include liver problems and severe skin reactions or rash. (See the WARNING above.)
Other possible side effects of darunavir 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 darunavir. To learn more about possible side effects of darunavir, 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 darunavir.
You can also 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 darunavir is available:
Janssen Pharmaceuticals, Inc.
The above Patient Version drug summary is based on the following FDA label(s): Oral suspension, tablet (film coated).