Prezista

Generic Name: darunavir (Oral route)

dar-UE-na-vir

Commonly used brand name(s)

In the U.S.

• Prezista

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For Prezista

Darunavir is used in combination with ritonavir (Norvir®) and other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is given to patients who have already had previous treatment for HIV or who have never taken HIV medicines in the past.

Darunavir will not cure HIV infection or prevent AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Darunavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using Prezista

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darunavir in children 3 years of age and older. Because of darunavir's toxicity, use in children younger than 3 years of age is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darunavir in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving darunavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Astemizole


• Cisapride


• Colchicine


• Dihydroergotamine


• Ergonovine


• Ergotamine


• Lovastatin


• Methylergonovine


• Midazolam


• Pimozide


• Rifampin


• Sildenafil


• Simvastatin


• St John's Wort


• Terfenadine


• Triazolam

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone


• Bepridil


• Bosentan


• Carbamazepine


• Dexamethasone


• Flecainide


• Fluticasone


• Lidocaine


• Lopinavir


• Propafenone


• Quinidine


• Rifabutin


• Salmeterol


• Saquinavir


• Tacrolimus


• Telaprevir


• Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atorvastatin


• Buprenorphine


• Clarithromycin


• Desogestrel


• Dienogest


• Digoxin


• Drospirenone


• Efavirenz


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Indinavir


• Ketoconazole


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Methadone


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Paroxetine


• Pravastatin


• Sertraline


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus or


• Hemophilia (a bleeding problem) or


• Hyperglycemia (high blood sugar) or


• Liver disease or other liver problems (e.g., cirrhosis, hepatitis)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use is not recommended in patients with this condition.

• Sulfa allergy, known or suspected—Use with caution. May make side effects worse.

Proper Use of Prezista

Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine is always taken with ritonavir (Norvir®). Take these two medicines at the same time, unless your doctor tells you otherwise.

If you also use didanosine (Videx®), take it at least 1 hour before or 2 hours after taking this medicine and ritonavir.

It is important that darunavir be taken with food in order to work properly.

Swallow the tablet whole with water or milk. Do not crush, break, or chew it.

If you are using the oral liquid, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.

If you take this medicine once a day and you miss a dose or forget to use it, and it is since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

If you take this medicine two times a day and you miss a dose or forget to use it, and it is since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (suspension or tablets):
  
  • For HIV infection (patient already had HIV treatment):
    
    • Adults—800 milligrams (mg) once a day with 100 mg of ritonavir (Norvir®), or 600 mg two times per day with 100 mg of ritonavir (Norvir®).
    
    
    • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 375 to 600 mg of darunavir taken with 50 to 100 mg of ritonavir (Norvir®) two times per day.
    
    
    • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 200 to 280 mg of darunavir taken with 32 to 48 mg of ritonavir (Norvir®) two times per day.
    
    
    • Children younger than 3 years of age—Use is not recommended.
    
    
  
  
  • For HIV infection (patient never had HIV treatment):
    
    • Adults—800 milligrams (mg) once a day with 100 mg of ritonavir (Norvir®).
    
    
    • Children 3 to 17 years of age and weighing 15 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 375 to 600 mg of darunavir taken with 50 to 100 mg of ritonavir (Norvir®) two times per day.
    
    
    • Children 3 to 17 years of age and weighing 10 kg to less than 15 kg—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 200 to 280 mg of darunavir taken with 32 to 48 mg of ritonavir (Norvir®) two times per day.
    
    
    • Children younger than 3 years of age—Use is not recommended.
    
    
  
  

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the oral liquid in its original container. Do not refrigerate or freeze it.

Precautions While Using Prezista

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), lovastatin (Altocor®, Altoprev®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), triazolam (Halcion®), or ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Ergotrate®, Methergine®, Migranal®, or Wigraine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John's wort) or vitamin supplements.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking an anti-viral medicine.

Birth control pills may not work as well while you are using darunavir. To keep from getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have certain infections, such as Pneumocystis pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Tell the doctor in charge that you or your child are taking this medicine before you have any medical tests. The results of some tests may be affected by this medicine.

Prezista Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blurred vision


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• increased hunger


• increased thirst


• increased urination


• skin rash


• sweating


• troubled breathing


• unexplained weight loss


• unusual tiredness or weakness

Rare

• Abdominal or stomach pain or tenderness


• acid or sour stomach


• belching


• blistering, peeling, or loosening of the skin


• bloating


• chills


• clay colored stools


• constipation


• cough


• dark urine


• decreased appetite


• diarrhea


• difficulty with moving


• dizziness


• excess air or gas in the stomach or intestines


• fast heartbeat


• fever


• full feeling


• headache


• heartburn


• indigestion


• itching


• joint or muscle pain


• lack or loss of strength


• light-colored stools


• loss of appetite


• muscle aching or cramping


• nausea and vomiting


• passing gas


• red skin lesions, often with a purple center


• red, irritated eyes


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• swelling of the feet or lower legs


• swollen joints


• unpleasant breath odor


• vomiting of blood


• yellow eyes or skin

Incidence not known

• Muscle pain or stiffness


• swelling or puffiness of the face

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Muscle aches


• stuffy or runny nose

Less common

• Constipation


• gaining weight around your neck, upper back, breast, face, or waist

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Prezista side effects (in more detail)

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More Prezista resources

• Prezista Side Effects (in more detail)
• Prezista Use in Pregnancy & Breastfeeding
• Prezista Drug Interactions
• Prezista Support Group
• 3 Reviews for Prezista - Add your own review/rating

• Prezista Prescribing Information (FDA)


• Prezista Monograph (AHFS DI)


• Prezista MedFacts Consumer Leaflet (Wolters Kluwer)


• Prezista Consumer Overview

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