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AIDSinfo Drug Database

AIDSinfo Drug Database

Drugs by class

FDA-approved

Investigational

Darunavir  Audio icon

Brand Name: Prezista
Other Names: DRV, darunavir ethanolate
Drug Class: Protease Inhibitors
Approved Use: Treatment of HIV Infection
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Drug Image:
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Prezista 100 mg/mL oral suspension
Prezista 75 mg
Prezista 150 mg tablet
Prezista 600 mg
Prezista 800 mg
Chemical Image:
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darunavir ethanolate
darunavir ethanolate
Molecular Weight: 593.7377

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 could be signs of liver problems:

  • Dark-colored urine.
  • Yellowing of your skin or the whites of your eyes (jaundice).
  • Pale-colored bowel movements.
  • Nausea.
  • Vomiting.
  • Pain or tenderness on the right side below your ribs.
  • Loss of appetite.
  • Tiredness.

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:

  • Fever.
  • Tiredness.
  • Muscle or joint pain.
  • Blisters or skin lesions.
  • Mouth sores or ulcers.
  • Conjunctivitis (redness or swelling of the eyes).

Taking darunavir with certain other medicines may cause serious, life-threatening 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 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.

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) infection or hepatitis c virus (HCV) infection.
  • 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. Whether darunavir can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking darunavir when pregnant.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking darunavir.
  • 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 AIDSinfo 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 (brand name: Prezista) comes in the following forms and strengths:

  • 75-mg tablets.
  • 150-mg tablets.
  • 600-mg tablets.
  • 800-mg tablets.  
  • 100-mg/mL oral suspension. (An oral suspension is a mixture of a medicine and a liquid that can be taken by mouth.)

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

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

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.

Take (or give) darunavir oral suspension with the oral dosing syringe that comes with the medicine. Shake the oral suspension well before each use. See the instructions that come with darunavir oral suspension for 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 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.)

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. Most side effects from darunavir are manageable, but a few can be serious. Serious side effects of darunavir include liver problems and severe skin reactions or rash. (See the WARNING box above.)

Other possible side effects of darunavir include:

  • Diabetes and high blood sugar (hyperglycemia).
  • Changes in body fat (including gain or loss of fat).
  • Immune reconstitution inflammatory syndrome (IRIS), 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.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to darunavir.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.

How should darunavir be stored?

  • Store darunavir tablets and oral suspension at room temperature, 77°F (25°C). Keep darunavir away from high heat. Do not refrigerate or freeze darunavir oral suspension.
  • Store darunavir oral suspension in the original container.
  • 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?

More information about darunavir is available:

Manufacturer Information

Janssen Pharmaceuticals, Inc.
800-526-7736

The above Patient Version drug summary is based on the following FDA label(s): Oral suspension, tablet (film coated).

Last Reviewed: September 20, 2016

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