Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir is not a cure for HIV or AIDS.

Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.

Darunavir may also be used for purposes not listed in this medication guide.

Stop taking this medicine and call your doctor right away if you have a severe skin reaction: fever, burning or redness in your eyes, mouth sores, or a skin rash that spreads and causes blistering and peeling.

Tell your doctor about all your other medicines. Some drugs should not be used with darunavir.

Darunavir can cause serious liver problems. Call your doctor if you have upper stomach pain, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Darunavir comes as a tablet and oral suspension (liquid) to take by mouth. It is usually taken with food and with ritonavir once or twice a day or with food and with cobicistat once a day. Take darunavir at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take darunavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not take darunavir without ritonavir or cobicistat.

Swallow the tablets/capsules 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 right amount of suspension from the bottle. You can swallow the suspension straight 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 and must always be given with a complete regimen. 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. When your supply of darunavir starts to run low, get more from your doctor or pharmacist.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Darunavir must be taken together with ritonavir and other antiviral medications. Use the medicine exactly as directed.

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

Darunavir works best if you take it with food. Take darunavir and ritonavir together at the same time every day.

Swallow the darunavir tablet whole and do not crush, chew, or break it.

Shake the oral suspension (liquid). Measure a dose with the supplied syringe or a dose-measuring device (not a kitchen spoon).

You will need frequent medical tests.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.

Store at room temperature away from moisture and heat.

You should not take darunavir if you have severe liver disease.

Some drugs should not be used with darunavir. Your treatment plan may change if you also use:

• alfuzosin;

• cisapride;

• colchicine (in people with liver or kidney disease);

• dronedarone;

• elbasvir and grazoprevir;

• lurasidone;

• naloxegol;

• pimozide;

• rifampin;

• sildenafil (Revatio, for pulmonary arterial hypertension);

• St. John's wort;

• triazolam or oral midazolam;

• heart medicine--ivabradine, ranolazine;

• cholesterol medication--lomitapide, lovastatin, simvastatin; or

• ergot medicines--dihydroergotamine, ergotamine, methylergonovine.

Tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• diabetes;

• a bleeding disorder such as hemophilia; or

• an allergy to sulfa drugs.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

Darunavir can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using darunavir, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Darunavir and ritonavir should not be given to a child younger than 3 years old, or a child who weighs less than 22 pounds (10 kilograms).

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Always take darunavir and ritonavir together.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Using darunavir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Darunavir may cause serious side effects. Call your doctor at once if you have:

• a skin rash, no matter how mild;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or

• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes).

Darunavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken darunavir). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects of darunavir may include:

• nausea, vomiting, diarrhea, stomach pain;

• headache;

• rash; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

If you also take didanosine (Videx), take your darunavir dose 2 hours before or 1 hour after you take didanosine.

Many drugs can affect darunavir, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to be sure it is safe for you to take darunavir and 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.