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Information

An Overview of Prezista (Darunavir, TMC114)

February 5, 2015

Prezista 75 mgPrezista 600 mgPrezista 150 mgPrezista 800 mg

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

Chemical Image:

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).
  • Light-colored bowel movements.
  • Nausea.
  • Vomiting.
  • Pain or tenderness on the right side below your ribs.
  • Loss of appetite.

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.
  • Red or inflamed eyes, like "pink eye" (conjunctivitis).

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 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 estrogen-based birth control (such as pills or injections). 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.
  • 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.
  • 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 given to you by your health care provider for using the drug.

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. Swallow darunavir tablets whole with a drink.

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

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?

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.

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).
  • 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. Tell your health care provider if you start having new symptoms after starting your HIV medicine.
  • Increased bleeding in people with hemophilia.
  • Diarrhea.
  • Nausea and/or vomiting.
  • Headache.
  • Abdominal pain.

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 also 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 bottle 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).


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More on Prezista (Darunavir, TMC114)


  
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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

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