dar-UE-na-vir

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

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:

• If you are allergic to darunavir, sulfa medicines, or any other medicines.
• If you have liver problems, including hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• If you have high blood sugar (hyperglycemia) or diabetes.
• If you have hemophilia.
• If you are pregnant or plan to become pregnant. Whether darunavir can harm an unborn baby is unknown. Use during pregnancy only if the potential benefit justifies the potential risk.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking darunavir.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Darunavir may affect the way other medicines or products work, and other medicines or products may affect how darunavir works. Taking darunavir together with certain medicines or products may cause serious side effects.

How should I take darunavir?

Darunavir comes in the following forms and strengths:

• 75-mg tablets (brand name: Prezista).
• 150-mg tablets (brand name: Prezista).
• 400-mg tablets (brand name: Prezista).
• 600-mg tablets (brand name: Prezista).
• 800-mg tablets (brand name: Prezista).
• 100-mg/mL oral suspension (brand name: Prezista).

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:

• Diabetes and high blood sugar (hyperglycemia).
• Changes in body fat (lipodystrophy).
• Changes in the immune system (immune reconstitution inflammatory syndrome).
• 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 darunavir. Ask your health care provider or pharmacist for more information on possible side effects of darunavir.

How should darunavir be stored?

• Store darunavir tablets and oral suspension at room temperature, 77°F (25°C). Avoid high heat.
• Do not refrigerate or freeze darunavir oral suspension. Store the oral suspension in its original container.
• Safely throw away darunavir that is no longer needed or expired (out of date).
• Keep darunavir and all medicines out of reach of children.

Where can I find more information about darunavir?

More information about darunavir is available:

• The darunavir drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking darunavir.
• Darunavir-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved generics for anti-HIV medicines, from FDA.

Manufacturer Information

Janssen Pharmaceuticals, Inc.
800-526-7736