Drug Database: Darunavir / Cobicistat

What are Prezcobix and Prezcobix PED?What are Prezcobix and Prezcobix PED?

What are Prezcobix and Prezcobix PED?

Prezcobix and Prezcobix PED are prescription medicines approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV in adults and children 3 years of age and older who weigh at least 33 lb (15 kg) and meet certain requirements, as determined by a health care provider. Prezcobix and Prezcobix PED are always used in combination with other HIV medicines.

Prezcobix and Prezcobix PED contain two different medicines: darunavir and cobicistat.

For more information on the use of Prezcobix and Prezcobix PED 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 using HIV medicines as directed by a health care provider helps people with HIV live longer, healthier 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.

What should I tell my health care provider before taking Prezcobix or Prezcobix PED?What should I tell my health care provider before taking Prezcobix or Prezcobix PED?

What should I tell my health care provider before taking Prezcobix or Prezcobix PED?

Before taking Prezcobix or Prezcobix PED, tell your health care provider:

• If you are allergic to any of the HIV medicines in Prezcobix or Prezcobix PED (darunavir or cobicistat), 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 kidney problems.
• 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 Prezcobix or Prezcobix PED during pregnancy. For more information on the use of Prezcobix or Prezcobix PED 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). Prezcobix and Prezcobix PED 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 Prezcobix or Prezcobix PED. 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. Prezcobix and Prezcobix PED may affect the way other medicines or products work, and other medicines or products may affect how Prezcobix and Prezcobix PED work. Taking Prezcobix or Prezcobix PED together with certain medicines or products may cause serious or life-threatening side effects.

How should I take Prezcobix or Prezcobix PED?How should I take Prezcobix or Prezcobix PED?

How should I take Prezcobix or Prezcobix PED?

Prezcobix and Prezcobix PED come in the following forms and strengths:

• Prezcobix tablets:
  • 800 mg darunavir and 150 mg cobicistat
  • 675 mg darunavir and 150 mg cobicistat
• Prezcobix PED tablets for oral suspension:
  • 600 mg darunavir and 90 mg cobicistat

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

Take Prezcobix or Prezcobix PED by mouth with food.

For children weighing at least 55 lb (25 kg) who cannot swallow the 675 mg/150 mg Prezcobix tablet whole, the tablet can be split by hand into two pieces. The line on the tablet will help you break the tablet into two pieces. After splitting the tablet, each part should be swallowed right away to get the full dose.

Prezcobix PED tablets for oral suspension must be dispersed in drinking water and taken right after it is prepared. Do not crush, chew, or swallow Prezcobix PED tablets for oral suspension. Read the “Instructions for Use” at the end of the Prezcobix and Prezcobix PED drug label for detailed instructions on how to prepare Prezcobix PED tablets for oral suspension.

Prezcobix tablets are not the same as Prezcobix PED tablets for oral suspension. Check to make sure you receive the correct dosage form each time you or your child’s prescription is filled.

Always take Prezcobix or Prezcobix PED in combination with other HIV medicines.

If you have taken too much Prezcobix or Prezcobix PED, 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 Prezcobix or Prezcobix PED, 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 Prezcobix or Prezcobix PED, 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 Prezcobix or Prezcobix PED cause?What side effects can Prezcobix or Prezcobix PED cause?

What side effects can Prezcobix or Prezcobix PED cause?

Prezcobix or Prezcobix PED may cause side effects. Some side effects of Prezcobix or Prezcobix PED 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 Prezcobix or Prezcobix PED 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 Prezcobix or Prezcobix PED. To learn more about possible side effects of Prezcobix or Prezcobix PED, 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 Prezcobix or Prezcobix PED be stored?How should Prezcobix or Prezcobix PED be stored?

How should Prezcobix or Prezcobix PED be stored?

• Store Prezcobix or Prezcobix PED at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep Prezcobix or Prezcobix PED in the container that it came in and keep the container tightly closed. Protect Prezcobix PED from light.
• Do not use Prezcobix or Prezcobix PED if the original seal over the container opening is broken or missing.
• Throw away Prezcobix or Prezcobix PED that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep Prezcobix, Prezcobix PED, and all medicines out of reach of children.

Where can I find more information about Prezcobix or Prezcobix PED?Where can I find more information about Prezcobix or Prezcobix PED?

Where can I find more information about Prezcobix or Prezcobix PED?

• For more information on the use of Prezcobix or Prezcobix PED 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): Tablet (film coated), tablet (for oral suspension). The Patient Package Insert and Instructions For Use include information for people taking Prezcobix or Prezcobix PED.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for darunavir and cobicistat available from MedlinePlus.
• Prezcobix- and Prezcobix PED-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.