Darunavir

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

Darunavir must be taken with ritonavir and other antiviral medications and should not be used by itself.

Darunavir may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Darunavir must be taken 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.

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.

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).

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty 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 immediately 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 lead to 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 a 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.

Take the medicine as soon as possible, but if it's almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Always take darunavir and ritonavir together.

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

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

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

Sometimes it is not safe to use certain medications together. Some drugs can change how much of another drug is in your blood, which may increase side effects or make the medications work less well.

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 together. 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.