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An Overview of Prezista (Darunavir, TMC114)

August 23, 2013

dar-UE-na-vir

Prezista 400mgPrezista 400mgPrezista 600mgPrezista 75mgPrezista 75mg

Brand Name: Prezista
Other Name(s): DRV, darunavir ethanolate
Drug Class: Protease Inhibitors
Approved Use: Treatment of HIV Infection

WARNING:

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 may signal liver problems:

Contact your health care provider right away if you develop a rash. Stop taking darunavir (and ritonavir, the anti-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.


What is darunavir?

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 anti-HIV medicine ritonavir (brand name: Norvir) and other anti-HIV medicines.

Darunavir is a type of anti-HIV medicine called a protease inhibitor (PI). Darunavir works by blocking protease, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.

Darunavir does not cure HIV/AIDS. It is not known if darunavir reduces the risk of passing HIV to other people.


What should I tell my health care provider before taking darunavir?

Before taking darunavir, tell your health care provider:


How should I take darunavir?

Darunavir comes in the following forms and strengths:

Take darunavir according to your health care provider's instructions.

Always take darunavir in combination with the anti-HIV medicine ritonavir (brand name: Norvir) and other anti-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. Shake the oral suspension well before each use.

If you take too much darunavir, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.

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.)


What should I do if I forget a dose?

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. Do not take two doses at the same time to make up for a missed dose.

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.


What side effects can darunavir cause?

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. Ask your health care provider or pharmacist for more information on possible side effects of darunavir.


How should darunavir be stored?


Where can I find more information about darunavir?

More information about darunavir is available:


Manufacturer Information

Janssen Pharmaceuticals, Inc.
800-526-7736




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