Prezista is a protease (PRO-tee-ayz) inhibitor antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Prezista is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

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

Prezista is not a cure for HIV or AIDS.

Stop taking Prezista 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.

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

Stop taking Prezista 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 current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Take Prezista exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Prezista must be taken together with ritonavir and other antiviral medications.

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

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

Swallow the Prezista 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.

Usual Adult Dose of Prezista for HIV Infection:

Therapy-naive Patients and Therapy-experienced Patients with No Darunavir Resistance Associated Substitutions: Darunavir 800 mg plus ritonavir 100 mg orally once a day with food

Therapy-experienced Patients with At Least 1 Darunavir Resistance Associated Substitution (including V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V): Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:
-Genotypic testing is recommended for therapy-experienced patients; however, when genotypic testing is not possible, darunavir 600 mg plus ritonavir 100 mg twice a day is recommended.

Use: In combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection:

3 to less than 18 years:
Therapy-naive Patients and Therapy-experienced Patients with No Darunavir Resistance Associated Substitutions:
Oral suspension:
10 to less than 15 kg: Darunavir 35 mg/kg plus ritonavir 7 mg/kg orally once a day with food
-or-
10 to less than 11 kg: Darunavir 350 mg plus ritonavir 64 mg orally once a day with food
11 to less than 12 kg: Darunavir 385 mg plus ritonavir 64 mg orally once a day with food
12 to less than 13 kg: Darunavir 420 mg plus ritonavir 80 mg orally once a day with food
13 to less than 14 kg: Darunavir 455 mg plus ritonavir 80 mg orally once a day with food
14 to less than 15 kg: Darunavir 490 mg plus ritonavir 96 mg orally once a day with food

Tablets and oral suspension:
15 to less than 30 kg: Darunavir 600 mg plus ritonavir 100 mg orally once a day with food
30 to less than 40 kg: Darunavir 675 mg plus ritonavir 100 mg orally once a day with food
40 kg or more: Darunavir 800 mg plus ritonavir 100 mg orally once a day with food

Therapy-experienced Patients with At Least 1 Darunavir Resistance Associated Substitution (including V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V):
Oral suspension:
10 to less than 15 kg: Darunavir 20 mg/kg plus ritonavir 3 mg/kg orally twice a day with food
-or-
10 to less than 11 kg: Darunavir 200 mg plus ritonavir 32 mg orally twice a day with food
11 to less than 12 kg: Darunavir 220 mg plus ritonavir 32 mg orally twice a day with food
12 to less than 13 kg: Darunavir 240 mg plus ritonavir 40 mg orally twice a day with food
13 to less than 14 kg: Darunavir 260 mg plus ritonavir 40 mg orally twice a day with food
14 to less than 15 kg: Darunavir 280 mg plus ritonavir 48 mg orally twice a day with food

Tablets and oral suspension:
15 to less than 30 kg: Darunavir 375 mg plus ritonavir 48 mg orally twice a day with food
30 to less than 40 kg: Darunavir 450 mg plus ritonavir 60 mg orally twice a day with food
40 kg or more: Darunavir 600 mg plus ritonavir 100 mg orally twice a day with food

Comments:
-Special vigilance recommended during dose selection, medication order transcription, dispensing information, and dosing instructions to reduce risk for medication errors, overdose, and underdose.
-Dose should not exceed the recommended adult dose.

Use: In combination with ritonavir and other antiretroviral agents, for the treatment of HIV-1 infection

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

Some drugs should not be used with Prezista. 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.

To make sure Prezista is safe for you, 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.

Prezista can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Prezista, 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.

Prezista 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 Prezista 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.

Taking Prezista 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 to Prezista (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).

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 this medicine). 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 Prezista side effects 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 Prezista dose 2 hours before or 1 hour after you take didanosine.

Many drugs can interact with 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.