(da roon' a veer)

Brand Name(s): Prezista^®

WHY is this medicine prescribed?

Darunavir is used to treat human immunodeficiency virus (HIV) infection.Darunavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood.

Although darunavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses.Taking these medications and making other lifestyle changes may decrease the risk of giving the HIV virus to other people.

Are there OTHER USES for this medicine?

Darunavir is also sometimes used to prevent infection in healthcare workers or other people who were accidentally exposed to HIV.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Darunavir comes as a tablet and oral suspension (liquid) to take by mouth. Take once or twice a day.Take darunavir at around the same time(s) every day.

Take darunavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You will take other medications for HIV while you are taking darunavir. Your doctor will tell you whether these medications should be taken at the same time as darunavir, or several hours before or after you take darunavir and if you should take them with or without food. Ask your doctor or pharmacist if you have questions about the times you should take your medications.

Swallow the tablets whole; do not split, chew, or crush them.

Shake the suspension well right before each use to mix the medication evenly. Use the oral dosing syringe that came with the medication to withdraw the correct amount of suspension from the bottle. You can swallow the suspension directly from the syringe. Wash the syringe with water and allow it to dry thoroughly after use.

Darunavir controls HIV but does not cure it. Darunavir also does not treat HIV infection alone.It is important that all of the medications prescribed by your doctor to treat HIV infection are taken together so that the medications will continue to work to control the infection.Continue to take darunavir even if you feel well. Do not stop taking darunavir without talking to your doctor. If you stop taking darunavir or skip doses, your condition may become more difficult to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking darunavir,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with darunavir. Other medications may cause dosing changes or extra monitoring when taken with darunavir. Make sure you have discussed any medications you are currently taking or plan to take before starting darunavir with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking darunavir, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with darunavir: St. John's wort; dextromethorphan; omeprazole (Prilosec^®). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking darunavir. Do not start any of these medications while taking darunavir without discussing with your healthcare provider.

• if you are taking didanosine, take it 1 hour before or 2 hours after you take darunavir.

• tell your doctor if you have or have ever had diabetes or high blood sugar; hemophilia (bleeding disorder in which the blood does not clot properly); hepatitis (swelling of the liver caused by a virus), cirrhosis (a disease which causes scarring of liver tissue), or any other liver disease; or an infection that does not go away or that comes and goes such as cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), mycobacterium avium complex disease (MAC; a bacterial infection that may cause serious symptoms in people with AIDS), pneumonia, or tuberculosis (TB; a type of lung infection).

• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking darunavir, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking darunavir.

• you should know that darunavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, injections, or implants). Ask your doctor to help you choose a method of birth control that will work for you.

• you should know that your body fat may increase or move to different areas of your body such as your breasts, upper back, neck, chest, and stomach area. Loss of fat from the legs, arms, and face can also happen.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking darunavir: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms at any time during your treatment with darunavir, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Darunavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• diarrhea
• nausea, vomiting
• stomach pain

Some side effects can be serious. If you experience any of these symptoms, stop taking darunavir and call your doctor immediately or get emergency medical treatment:

• rash; peeling or blistering skin; mouth sores; red, swollen, itchy, or teary eyes; muscle or joint aches
• fever, swelling, tenderness, redness, or other signs of infection
• nausea, extreme tiredness, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, pale or dark stools

Darunavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to darunavir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2025.