Prezista

Pronunciation

Generic Name: darunavir (da ROON a veer)
Brand Names: Prezista

What is Prezista?

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

Prezista is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Darunavir is not a cure for HIV or AIDS.

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

Important information

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

Unwanted or dangerous effects may occur if you take Prezista with alfuzosin, cisapride, pimozide, lovastatin, simvastatin, oral midazolam, triazolam, rifampin, sildenafil (for treating pulmonary arterial hypertension), St. John's wort, or an ergot medicine (dihydroergotamine, ergonovine, ergotamine, methylergonovine).

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Before taking this medicine

You should not take Prezista if you are allergic to darunavir or ritonavir (Norvir, Kaletra), or if you have severe liver disease.

Some medicines can cause unwanted or dangerous effects when used with Prezista. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;

  • cisapride;

  • pimozide;

  • lovastatin or simvastatin;

  • rifampin;

  • sildenafil (for pulmonary arterial hypertension);

  • St. John's wort;

  • triazolam or oral midazolam; or

  • ergot medicines--dihydroergotamine, ergonovine, ergotamine, methylergonovine.

To make sure Prezista is safe for you, tell your doctor if you have:

  • liver disease (especially hepatitis or cirrhosis);

  • diabetes;

  • a bleeding disorder such as hemophilia;

  • high cholesterol or triglycerides; or

  • if you are allergic to sulfa drugs.

FDA pregnancy category C. It is not known whether Prezista will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

See also: Pregnancy and breastfeeding warnings (in more detail)

Prezista can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking Prezista.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the 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.

How should I take Prezista?

Take Prezista exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Prezista must be taken together with another medication called ritonavir. Take the medicines together at the same time every day.

Take the tablets with a full glass (8 ounces) of water or milk. Swallow the tablet whole. Do not break or chew.

Prezista works best if you take it with food.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with the oral dosing syringe provided with this medicine. If you did not receive an oral syringe with your medication, ask your pharmacist for one.

While using Prezista, you may need frequent blood tests at your doctor's office.

Use Prezista regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose of Prezista and ritonavir as soon as you remember and take your next dose at the regularly scheduled time.

If you take Prezista once daily and you are more than 12 hours late in taking your medications, skip the missed dose and take the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

If you take this medicine twice daily and you are more than 6 hours late in taking your medications, skip the missed dose and take the next regularly scheduled dose.

Always take Prezista and ritonavir together. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid?

If you also take didanosine (Videx), take it 1 hour before or 2 hours after you take Prezista.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Prezista side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Prezista: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Prezista and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Prezista may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with this medicine. Tell your doctor if you have:

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

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

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

Common Prezista side effects may include:

  • vomiting, mild stomach pain;

  • headache;

  • mild skin 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.

See also: Side effects (in more detail)

What other drugs will affect Prezista?

Many drugs can interact with Prezista. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Prezista, especially:

  • artemether and lumefantrine;

  • bosentan;

  • colchicine;

  • risperidone or thioridazine;

  • salmeterol;

  • an antibiotic or antifungal medication;

  • an antidepressant--desipramine, paroxetine, sertraline, trazodone, and others;

  • any other HIV/AIDS medicines;

  • a blood thinner such as warfarin, Coumadin;

  • cholesterol lowering medication--atorvastatin, pravastatin, rosuvastatin;

  • heart or blood pressure medicine--felodipine, metoprolol, nicardipine, nifedipine, timolol, and others;

  • drugs that weaken the immune system--cyclosporine, sirolimus, tacrolimus;

  • a heart rhythm medication--amiodarone, digoxin, digitalis, flecainide, lidocaine, propafenone, quinidine;

  • the hepatitis C medications boceprevir or telaprevir;

  • insulin or diabetes medication you take by mouth;

  • medicines to treat erectile dysfunction--sildenafil, tadalafil, vardenafil, Viagra;

  • narcotic medication--buprenorphine, methadone;

  • seizure medications--carbamazepine, phenobarbital, phenytoin; or

  • steroids (oral, nasal, inhaled, or injectable).

This list is not complete and many other drugs can interact with Prezista. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Prezista.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Prezista only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 6.01. Revision Date: 2013-04-08, 7:56:34 AM.

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