Drug Database: Darunavir

What is darunavir?What is 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 in adults and children. Darunavir is always used with a pharmacokinetic enhancer (boosting agent) in combination with other HIV medicines. Currently, ritonavir is the only boosting agent available for use with stand-alone darunavir.

Fixed-dose combination tablets containing darunavir and the boosting agent cobicistat (brand names: Prezcobix and Prezcobix PED) are 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, but using HIV medicines as directed by a health care provider helps people with HIV live long, healthy lives. HIV medicines also reduce the risk of HIV transmission. If you are using HIV medicines, do not cut down on, skip, or stop using them unless your health care provider tells you to. For more information about using your HIV medicines as prescribed and ways to overcome barriers to medication adherence, please read the HIVinfo fact sheet on HIV Treatment Adherence.

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

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 benefits and risks 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 breastfeeding or plan to breastfeed. For mothers with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. Mothers with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk. Although most medicines are safe to use while breastfeeding, some medicines should be avoided. Always let your health care provider know about all the medicines and supplements you are using before you start breastfeeding.
• If you are using hormone-based birth control (such as injections, vaginal rings, implants, contraceptive patches, or birth control pills). 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.

How should I take darunavir?How should I take darunavir?

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. While taking darunavir, it is important to keep all your appointments with your health care provider.

Darunavir is always used with a boosting agent. Currently, the only boosting agent available for use with stand-alone darunavir is ritonavir. Take darunavir and ritonavir by mouth at the same time with food.

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

If your child is prescribed darunavir, follow the instructions for using the drug given to you by their health care provider. Darunavir dosing for children is based on body weight. Tell your child’s health care provider if your child’s weight changes.

Take (or give) darunavir oral suspension using the oral dosing syringe that comes with the medicine. Shake the oral suspension well before each use. For information about the correct way to prepare and take a dose of darunavir oral suspension, read the “Instructions for Use” that come with the medicine and appear at the bottom of the drug label.

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?What should I do if I forget a dose?

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?What side effects can darunavir cause?

What side effects can darunavir cause?

Darunavir may cause side effects. Many side effects from HIV medicines, such as darunavir, are temporary and manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information. Some side effects of darunavir can be serious, as described below.

• 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.
• Changes in body fat (lipodystrophy syndrome).
• Liver problems. Some people taking darunavir in combination with ritonavir may develop liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking darunavir. Liver function tests may be done before and during treatment with darunavir. Contact your health care provider right away if you have any of the following symptoms: yellowing of your skin or the whites of your eyes (jaundice); dark-colored urine; light-colored bowel movements; loss of appetite for several days or longer; nausea or vomiting; pain, aching, or tenderness on the right side of your stomach/abdominal area; or itching.
• Diabetes and high blood sugar (hyperglycemia). Rarely, some people taking darunavir may get high blood sugar, develop diabetes, or have worsening diabetes. Let your health care provider know if you have increased thirst or if you urinate more frequently while taking darunavir.
• Increased bleeding in people with hemophilia.
• Skin rash and allergic reactions. Mild rash can occur with darunavir. In rare cases, rashes may be severe. Contact your health care provider right away if you develop a rash while taking darunavir. Stop taking darunavir and get medical help right away if you develop a rash with any of the following symptoms: general ill feeling (malaise); extreme tiredness; muscle or joint aches; fever; blistering or peeling skin; blisters or sores in your mouth; redness or swelling of the eyes (conjunctivitis); swelling of your face, lips, mouth, tongue, throat, or lymph nodes; or trouble breathing or swallowing.

Tell your health care provider if you have any side effects that bother you or that do 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.

What medicines can interact with darunavir?What medicines can interact with darunavir?

What medicines can interact with darunavir?

HIV medicines may interact with other medicines and supplements. Before starting darunavir, tell your health care provider about all the prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Taking darunavir together with certain medicines or products may cause serious side effects.

For a list of medicines that may interact with darunavir, see the drug label or ask your health care provider or pharmacist. You can also look up potential interactions between your HIV medicines and other drugs using the HIV Drug Interaction Checker online.

How should darunavir be stored?How should darunavir be stored?

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?Where can I find more information about darunavir?

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); ritonavir tablet (film coated), oral powder; and Prezcobix tablet (film coated), Prezcobix PED tablet (for suspension). The Patient Package Insert, Instructions For Use, and Patient Information section of the label 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.