Prezista

The active ingredient in Prezista is darunavir ethanolate. It belongs to the drug class called protease inhibitors and is used for the treatment of HIV. HIV produces a protein (enzyme) called protease, which helps the virus multiply and infect healthy cells. Prezista blocks the action of this protein, preventing HIV from making copies of itself and decreasing the amount of HIV in the blood (viral load).

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Prezista. However, the following is a synopsis of the general guidelines for the use of Prezista:

• Darunavir dosing in children is based on their weight or body fat. If your child gains or loses weight, their dosage may change.
• Prezista works best when taken with food. Take Prezista and Norvir (ritonavir) at the same time every day.
• Swallow the Prezista tablet whole; do not crush, chew, or break it.
• Shake the oral suspension (liquid). Use the supplied syringe or dose-measuring instrument (not a household spoon).
• You will require frequent medical examinations.

Some mild or most common side effects of Prezista seen in clinical trials include:

• Diarrhea.
• Rash.
• Nausea.
• Indigestion.
• Vomiting.
• Feeling weak.
• Tiredness.
• Loss of appetite and weight loss.
• High blood sugar levels.
• Muscle pain.
• Abdominal pain.

Some individuals may experience serious side effects while using Prezista. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe, life-threatening allergic reactions include face swelling, hives, rash, itchy skin, and difficulty breathing.
• Severe skin reactions with a severe rash, fever, muscle or joint pain, mouth sores, and blistering or peeling of the skin.
• Serious liver problems include nausea, vomiting, a lack of appetite, pain on the right side of the stomach, yellowing of the skin or eyes, black urine, and light stool.
• Immune reconstitution syndrome. This change in your immune system from HIV medicines like Prezista can cause pain, fever, new or worsening infections, bulging eyes, joint pain, and neurological symptoms.

These are not all of the possible side effects of Prezista. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Prezista, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver disease, especially hepatitis B or C.
• Diabetes.
• Allergy to sulfa medications.
• Bleeding disorders like hemophilia.
• Pregnant or plan on becoming pregnant.
• Breastfeeding or plan on breastfeeding.

• Taken with some medications that can increase the risk of major adverse effects (e.g., alfuzosin (Uroxatral), Multaq (dronedarone), lovastatin, simvastatin (Zocor), triazolam (Halcion).
• Hypersensitivity to darunavir.

Prezista (darunavir) starts acting quickly after the initial dose to help reduce the viral load of HIV, but the results are evaluated over time using blood tests. When used consistently with other antiretroviral agents, most people have a considerable decline in viral load within 2 to 4 weeks, with continuous improvement over the following few months.

When Prezista is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Alfuzosin.
• Cisapride.
• Colchicine (in patients with liver or kidney problems).
• Dronedarone.
• Grazoprevir and elbasvir.
• Lurasidone.
• Naloxegol.
• Pimozide.
• Rifampin.
• Lopinavir.
• Raltegravir.
• Quinidine.
• Tenofovir.
• Sildenafil (Revatio), which is used to treat pulmonary arterial hypertension.
• St. John's Wort.
• Triazolam, or oral midazolam.
• Ivabradine and ranolazine.
• Lovastatin, simvastatin, and lomitapide, which are all cholesterol medications.
• Ergot medications include dihydroergotamine, ergotamine, and methylergonovine.

Adults: The normal dose is 800 mg tablet orally once a day, with 100 mg ritonavir (Norvir) and meals.

Children 3 years of age and older: The dosage will be based on your child's weight.

10 kg (22 lbs) to under 15 kg (33 lbs): The dosage ranges from 350 mg to 490 mg administered orally once a day with 64 mg to 96 mg of ritonavir (Norvir) and meals.

From 15 kg (33 lbs) to less than 30 kg (66 lbs): The normal dose is 600 mg administered orally once a day with 100 mg of ritonavir (Norvir) and meals.

30 kg (66 lbs) and less than 40 kg (88 lbs): The normal dose is 675 mg taken orally once a day with 100 mg of ritonavir (Norvir) and meals.

40 kg (88 pounds) or more: The normal dose is 800 mg administered orally once a day with 100 mg of ritonavir (Norvir) with food.

If used with cobicistat, the medicine is taken once daily; if used with ritonavir, it is taken once or twice daily.

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

Store at room temperature and keep out of reach of children.

Janssen Pharmaceuticals is the company that manufactures Prezista.

There are several lower-cost generic versions available of Prezista.

You should not stop taking Prezista (darunavir) without consulting your doctor. Because it is part of HIV combination therapy, abruptly ceasing can cause the virus to replicate, increasing your viral load and leading to drug resistance.

To prevent HIV in a newborn, take any medications used to treat your infection during pregnancy. If you are pregnant and taking Prezista (darunavir), you should enroll in the Antiretroviral Pregnancy Registry (APR). The APF collects information about you and your baby while taking Prezista.

Prezista has been shown to reduce the effectiveness of hormonal birth control methods such as pills, injections, implants, skin patches, and vaginal rings. To avoid conception while using Prezista, use a barrier method of birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

Women who have HIV should not breastfeed. The virus might spread to your infant through breast milk.