Drug Database: Darunavir

What is darunavir?

Darunavir (brand name: Prezista) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children. Darunavir is always used in combination with a pharmacokinetic enhancer — either ritonavir (brand name: Norvir) or cobicistat (brand name: Tybost) — and other HIV medicines.

• When darunavir is taken with ritonavir, it may be used in adults and children 3 years of age and older who weigh at least 22 lb (10 kg).
• When darunavir is taken with cobicistat, it may be used in adults and children weighing at least 88 lb (40 kg) who meet certain requirements, as determined by a health care provider.
• (A fixed-dose combination tablet containing darunavir and cobicistat [brand name: Prezcobix] is also available.)

For more information on the use of darunavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

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, sulfonamides (sulfa medicines), or any other medicines.
• If you have liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have high blood sugar (hyperglycemia) or diabetes.
• If you have hemophilia.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking darunavir during pregnancy. For more information on the use of darunavir during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Darunavir may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking darunavir. For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John’s wort) 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, life-threatening side effects.

How should I take darunavir?

Darunavir comes in the following forms and strengths:

• 75-mg, 150-mg, 600-mg, and 800-mg tablets
• 100-mg/mL oral suspension

Take darunavir according to your health care provider’s instructions. Do not miss a dose of darunavir, and do not change your dose or stop taking darunavir without first talking with your health care provider.

If your child is prescribed darunavir, follow the instructions for using the drug given to you by their health care provider.

Darunavir is always used with a boosting agent — ritonavir or cobicistat. Take darunavir and either ritonavir or cobicistat by mouth at the same time with food.

Always take darunavir and either ritonavir or cobicistat in combination with other HIV medicines.

Take (or give) darunavir oral suspension using the oral dosing syringe that comes with the medicine. Shake the oral suspension well before each use. See the “Instructions for Use” that come with darunavir oral suspension for more information about the right way to prepare and take a dose.

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 have taken too much darunavir, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.

For more information on how to take darunavir, see the FDA drug label.

What should I do if I forget a dose?

If you miss a dose of darunavir, 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.

What side effects can darunavir cause?

Darunavir may cause side effects. Some side effects of darunavir can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of darunavir include:

• Diabetes and high blood sugar (hyperglycemia).
• Changes in body fat (lipodystrophy syndrome).
• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• 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. 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.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should darunavir be stored?

• Store darunavir tablets and oral suspension at room temperature, 77°F (25°C). Keep darunavir oral suspension away from high heat. Do not refrigerate or freeze darunavir oral suspension.
• Keep darunavir in the container that it came in and keep the container tightly closed.
• Do not use darunavir if the original seal over the container opening is broken or missing.
• Throw away darunavir that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep darunavir and all medicines out of reach of children.

Where can I find more information about darunavir?

• For more information on the use of darunavir in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
• This Patient Version drug summary is based on the following FDA label(s): darunavir oral suspension, tablet (film coated); Prezcobix tablet, film coated; and cobicistat tablet (film coated). The Patient Package Insert and Instructions For Use include information for people taking darunavir.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for darunavir available from MedlinePlus.
• Darunavir-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests.)
• A list of FDA-approved HIV medicines, from HIVinfo.