PREZISTA
(pre-ZIS-ta)
(darunavir) Oral Suspension

PREZISTA
(pre-ZIS-ta)
(darunavir) Tablets

Read this Patient Information before you start taking PREZISTA and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Also read the Patient Information leaflet for NORVIR® (ritonavir).

What is the most important information I should know about PREZISTA?

• PREZISTA can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with PREZISTA. See the section “Who should not take PREZISTA?”
• PREZISTA may cause liver problems. Some people taking PREZISTA in combination with NORVIR® (ritonavir) have developed liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your combination treatment with PREZISTA. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems.
• Tell your healthcare provider if you have any of the below signs and symptoms of liver problems.
  • Dark (tea colored) urine
  • yellowing of your skin or whites of your eyes
  • pale colored stools (bowel movements)
  • nausea
  • vomiting
  • pain or tenderness on your right side below your ribs
  • loss of appetite

PREZISTA may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. You should call your healthcare provider immediately if you develop a rash. However, stop taking PREZISTA and ritonavir combination treatment and call your healthcare provider immediately if you develop any skin changes with symptoms below:

• fever
• tiredness
• muscle or joint pain
• blisters or skin lesions
• mouth sores or ulcers
• red or inflamed eyes, like “pink eye” (conjunctivitis)

Rash occurred more often in people taking PREZISTA and raltegravir together than with either drug separately, but was generally mild.

See “What are the possible side effects of PREZISTA?” for more information about side effects.

What is PREZISTA?

PREZISTA is a prescription anti-HIV medicine used with ritonavir and other anti-HIV medicines to treat adults and children 3 years of age and older with human immunodeficiency virus (HIV-1) infection. PREZISTA is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

When used with other HIV medicines, PREZISTA may help to reduce the amount of HIV in your blood (called “viral load”). PREZISTA may also help to increase the number of white blood cells called CD4 (T) cell which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).

Children under 3 years of age should not take PREZISTA.

PREZISTA does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using PREZISTA.

Avoid doing things that can spread HIV-1 infection.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Ask your healthcare provider if you have any questions on how to prevent passing HIV to other people.

Who should not take PREZISTA?

Do not take PREZISTA with any of the following medicines:

• alfuzosin (Uroxatral®)
• dihydroergotamine (D.H.E. 45®, Embolex®, Migranal®), ergonovine, ergotamine (Cafergot®,Ergomar®) methylergonovine
• cisapride
• pimozide (Orap®) • oral midazolam, triazolam (Halcion®)
• the herbal supplement St. John's Wort (Hypericum perforatum)
• the cholesterol-lowering medicines lovastatin (Mevacor®, Altoprev®, Advicor®) or simvastatin (Zocor®, Simcor®, Vytorin®)
• rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®)
• sildenafil (Revatio®) only when used for the treatment of pulmonary arterial hypertension.

Serious problems can happen if you or your child take any of these medicines with PREZISTA.

What should I tell my doctor before I take PREZISTA?

PREZISTA may not be right for you. Before taking PREZISTA, tell your healthcare provider if you:

• have liver problems, including hepatitis B or hepatitis C
• are allergic to sulfa medicines
• have high blood sugar (diabetes)
• have hemophilia
• are pregnant or planning to become pregnant. It is not known if PREZISTA will harm your unborn baby.
  Pregnancy Registry: You and your healthcare provider will need to decide if taking PREZISTA is right for you. If you take PREZISTA while you are pregnant, talk to your healthcare provider about how you can be included in the Antiretroviral Pregnancy Registry. The purpose of the registry is follow the health of you and your baby.
• are breastfeeding or plan to breastfeed. Do not breastfeed. We do not know if PREZISTA can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using PREZISTA and certain other medicines may affect each other causing serious side effects. PREZISTA may affect the way other medicines work and other medicines may affect how PREZISTA works.

Especially tell your healthcare provider if you take:

• other medicine to treat HIV
• estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.
• medicine for your heart such as bepridil, lidocaine (Xylocaine Viscous®), quinidine (Nuedexta®) , amiodarone (Pacerone®, Cardarone®), digoxin (Lanoxin®), flecainide (Tambocor®), propafenone (Rythmol®)
• warfarin (Coumadin®, Jantoven®)
• medicine for seizures such as carbamazepine (Carbatrol®, Equetro®, Tegretol®, Epitol®), phenobarbital, phenytoin (Dilantin®, Phenytek®)
• medicine for depression such as trazadone and desipramine (Norpramin®)
• clarithromycin (Prevpac®, Biaxin®)
• medicine for fungal infections such as ketoconazole (Nizoral®), itraconazole (Sporanox®, Onmel®), voriconazole (VFend®)
• colchicine (Colcrys®, Col-Probenecid®)
• rifabutin (Mycobutin®)
• medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor®, Toprol-XL®), timolol (Cosopt®, Betimol®, Timoptic®, Isatolol®, Combigan®)
• midazolam administered by injection
• medicine for heart disease such as felodipine (Plendil®), nifedipine (Procardia®, Adalat CC®, Afeditab CR®), nicardipine (Cardene®)
• steroids such as dexamethasone, fluticasone (Advair Diskus®, Veramyst®, Flovent®, Flonase®)
• bosentan(Tracleer®)
• medicine to treat chronic hepatitis C such as boceprevir (Victrelis™), telaprevir (Incivek™)
• medicine for cholesterol such as pravastatin (Pravachol®), atorvastatin (Lipitor®), rosuvastatin (Crestor®)
• medicine to prevent organ transplant failure such as cyclosporine (Gengraf®, Sandimmune®, Neoral®), tacrolimus (Prograf®), sirolimus (Rapamune®)
• salmeterol (Advair®, Serevent®)
• medicine for narcotic withdrawal such as methadone (Methadose®, Dolophine Hydrochloride), buprenorphine (Butrans®, Buprenex®, Subutex®), buprenorphine/naloxone (Suboxone®)
• medicine to treat schizophrenia such as risperidone (Risperdal®), thioridazine
• medicine to treat erectile dysfunction or pulmonary hypertension such as sildenafil ( Viagra®, Revatio®), vardenafil ( Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®)
• medicine to treat anxiety, depression or panic disorder such as sertraline (Zoloft®), paroxetine (Paxil®, Pexeva®)
• medicine to treat malaria such as artemether/lumefantrine (Coartem®)

This is not a complete list of medicines that you should tell your healthcare provider that you are taking. Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking PREZISTA without first talking with your healthcare provider.

How should I take PREZISTA?

• Take PREZISTA every day exactly as prescribed by your healthcare provider.
• You must take ritonavir (NORVIR®) at the same time as PREZISTA.
• Do not change your dose of PREZISTA or stop treatment without talking to your healthcare provider first.
• Take PREZISTA and ritonavir (NORVIR®) with food.
• Swallow PREZISTA tablets whole with a drink. If you have difficulty swallowing PREZISTA tablets, PREZISTA oral suspension is also available. Your health care provider will help decide whether PREZISTA tablets or oral suspension is right for you.
• If your child is taking PREZISTA, your child's healthcare provider will decide the right dose based on your child's weight. Your child's healthcare provider will tell you how much PREZISTA (tablets or oral suspension) and how much ritonavir (NORVIR®) (capsules, tablets or solution) your child should take. Your child should take PREZISTA with ritonavir with food. If your child does not tolerate ritonavir oral solution, ask your child's healthcare provider for advice.
• PREZISTA oral suspension should be given with the supplied oral dosing syringe. Shake the suspension well before each use. See the Instructions for Use that come with PREZISTA oral suspension for information about the right way to prepare and take a dose.
• If your or your child's prescribed dose of PREZISTA oral suspension is more than 6 mL, you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose. Ask your healthcare provider or pharmacist if you are not sure.
• If you take too much PREZISTA, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I do if I miss a dose?

People who take PREZISTA one time a day:

• If you miss a dose of PREZISTA by less than 12 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.
• If you miss a dose of PREZISTA by more than 12 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time.

People who take PREZISTA two times a day

• If you miss a dose of PREZISTA by less than 6 hours, take your missed dose of PREZISTA right away. Then take your next dose of PREZISTA at your regularly scheduled time.
• If you miss a dose of PREZISTA by more than 6 hours, wait and then take the next dose of PREZISTA at your regularly scheduled time.

If a dose of PREZISTA is skipped, do not double the next dose. Do not take more or less than your prescribed dose of PREZISTA at any one time.

What are the possible side effects of PREZISTA?

PREZISTA can cause side effects including:

• See “What is the most important information I should know about PREZISTA?”
• Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including PREZISTA can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often while taking PREZISTA.
• Changes in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back, chest, and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting your HIV medicine.
• Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including PREZISTA.

The most common side effects of PREZISTA include:

• diarrhea
• headache
• nausea
• abdominal pain
• rash
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of PREZISTA. For more information, ask your health care provider.

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

How should I store PREZISTA?

• Store PREZISTA oral suspension and tablets at room temperature [77°F (25°C)].
• Do not refrigerate or freeze PREZISTA oral suspension.
• Keep PREZISTA away from high heat.
• PREZISTA oral suspension should be stored in the original container.

Keep PREZISTA and all medicines out of the reach of children.

General information about PREZISTA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PREZISTA for a condition for which it was not prescribed. Do not give PREZISTA to other people even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information about PREZISTA. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PREZISTA that is written for health professionals.

For more information, call 1-800-526-7736.

What are the ingredients in PREZISTA?

Active ingredient: darunavir Inactive ingredients:

PREZISTA Oral Suspension: hydroxypropyl cellulose, microcrystalline cellulose, sodium carboxymethylcellulose, methylparaben sodium, citric acid monohydrate, sucralose, masking flavor, strawberry cream flavor, hydrochloric acid (for pH adjustment), purified water.

PREZISTA 75 mg and 150 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® White (polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 400 mg and 600 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose. The film coating contains: OPADRY® Orange (FD&C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

PREZISTA 800 mg Tablets: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hypromellose. The film coating contains: OPADRY® Dark Red (iron oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, titanium dioxide).

This Patient Information has been approved by the U.S Food and Drug Administration.

INSTRUCTIONS FOR USE

PREZISTA®
(pre-ZIS-ta)
(darunavir) Oral Suspension

Be sure that you read, understand, and follow these Instructions for Use so that you measure and take PREZISTA Oral Suspension correctly. Ask your healthcare provider or healthcare provider if you are not sure.

Each PREZISTA Oral Suspension carton contains:

• 1 bottle of PREZISTA Oral Suspension
• Oral dosing syringe
• 1 oral syringe adapter

Important information for use:

• Shake PREZISTA Oral Suspension well before each use.
• PREZISTA Oral Suspension should be given with the oral dosing syringe provided to make sure you measure the right amount. The oral dosing syringe provided with your PREZISTA Oral Suspension should not be used for any other medicines.

1. Shake the bottle.

• Shake the bottle well before each use (See Figure A).

Figure A: Shake the bottle

2. Open the bottle of PREZISTA Oral Suspension.

• Open the bottle by pushing downward on the cap and twisting it in the direction of the arrow (counter-clockwise) (See Figure B).

Figure B: Opening the bottle

3. The first time a bottle of PREZISTA Oral Suspension is used:

• Insert the oral syringe adapter into the bottle. Press on the adapter until it is even with the top of the bottle (See Figure C).
• Do not remove the oral syringe adapter from the bottle once inserted.

Figure C: Inserting the adapter

4. Insert the oral dosing syringe.

• Fully push down (depress) the plunger of the syringe.
• Insert the syringe into the opening in the oral syringe adapter until it is firmly in place (See Figure D).

Figure D: Inserting the syringe

5. Withdraw the prescribed amount of PREZISTA Oral Suspension.

• Turn the bottle upside down. Gently pull back the plunger of the syringe until the bottom of the plunger is even with markings on the syringe for the prescribed dose (See Figure E). If air bubbles form in the syringe, empty the Oral Suspension in the syringe back into the bottle. Then repeat steps 4 and 5.
• If you or your child's dose of PREZISTA Oral Suspension is more than 6 mL, you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose.

Figure E: Withdrawing the Oral Suspension

6.Turn the bottle right-side up and remove the syringe from the bottle by pulling straight up on the oral dosing syringe (See Figure F).

Figure F: Removing the syringe

7. Take the dose of PREZISTA.

• Place the tip of the oral dosing syringe in the mouth.
• Press on the plunger of the syringe towards the mouth (See Figure G).
• If you or your child's dose is more than 6 mL you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to divide the dose, and repeat steps 4 through 7.

Figure G: Taking the dose of PREZISTA

8. Close the bottle with the cap after use (See Figure H).

Figure H: Closing the bottle

9. Remove the plunger from the barrel, rinse both with water and allow to air dry after each use (See Figure I).

Figure I: Rinsing the syringe

10. Put the oral dosing syringe back together after air drying and store with PREZISTA Oral Suspension (See Figure J).

Figure J: Putting the syringe back together

How should I store PREZISTA?

• Store PREZISTA Oral Suspension and the oral dosing syringe at room temperature 77°F (25°C).
• Do not refrigerate or freeze PREZISTA Oral Suspension.
• Keep PREZISTA Oral Suspension away from high heat.
• Store PREZISTA Oral Suspension in the original container.

Keep PREZISTA and all medicines out of the reach of children.

This Instruction for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 5/13/2013
This monograph has been modified to include the generic and brand name in many instances.