PREZISTA Indication

PREZISTA™ is a prescription medication. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors (PIs).

PREZISTA is always used with 100 mg ritonavir (Norvir®) in combination with other HIV medicines for the treatment of HIV infection in treatment-experienced adult patients, such as those with HIV resistant to more than one PI.

• The use of other medications active against your HIV in combination with PREZISTA/ritonavir (Norvir®) may increase the likelihood of your overall treatment response. Your healthcare professional will work with you to find the right combination of other HIV meds.
  
  
• The long-term benefits and side effects of PREZISTA therapy are unknown at this time. It is important that you remain under the care of your healthcare professional.

PREZISTA is not approved for the treatment of HIV infection in adult patients who have never taken HIV medications before or in pediatric patients.

PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

Please read Important Safety Information below, and talk to your doctor to learn more about PREZISTA.

Important Safety Information

• Do not take PREZISTA if you are allergic to PREZISTA or any of its ingredients, or ritonavir (Norvir®).
  
  
• Please refer to the ritonavir (Norvir®) Product Information (PI and PPI) for additional information on precautionary measures.
  
  
• Taking PREZISTA with certain medicines could cause serious and/or life-threatening side effects or may result in loss of its effectiveness. Do not take PREZISTA if you are taking the following medicines: astemizole (Hismanal®), terfenadine (Seldane®), dihydroergotamine (D.H.E.45®, Migranal®), ergonovine, ergotamine (Wigraine®, Ergostat®, Cafergot®, Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), midazolam (Versed®), triazolam (Halcion®), rifampin (Rifadin®, Rifater®, Rifamate®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), lovastatin (Mevacor®), pravastatin (Pravachol®), simvastatin (Zocor®), carbamazepine (Tegretol®, Carbatrol®), phenobarbital, phenytoin (Dilantin®, Phenytek®), or products containing St. John's Wort.
  
  
• Before taking PREZISTA, tell your doctor if you are taking sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®), atorvastatin (Lipitor®), atorvastatin/amlodipine (Caduet®), or rosuvastatin (Crestor®). This is not a complete list of medicines. Be sure to tell your doctor about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
  
  
  
• Tell your doctor if you are taking estrogen-based contraceptives. PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as condom.
  
  
• Before taking PREZISTA, tell your doctor if you have any medical conditions, including allergy to sulfa medicines, diabetes, liver problems (including hepatitis B or C) or hemophilia.
  
  
• Tell your doctor if you are pregnant or planning to become pregnant, or are breastfeeding.
  
  
• The effects of PREZISTA on pregnant women or their unborn babies are not known. You and your doctor will need to decide if taking PREZISTA is right for you.
  
  
• You should not breastfeed if you have HIV or are taking PREZISTA.
  
  
• Skin rashes ranging from mild to severe or life-threatening have been reported in some patients receiving a PREZISTA-ritonavir regimen. Contact your doctor if you develop a rash.
  
  
• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines like PREZISTA.
  
  
• Changes in body fat have been seen in some patients taking anti-HIV medicines. The cause and long-term health effects of these conditions are not known at this time.
  
  
• As with other protease inhibitors, taking PREZISTA may strengthen the body's immune response enabling it to begin to fight infections that have been hidden. Patients may experience signs and symptoms of inflammation that can include swelling, tenderness or redness.
  
  
• The most common side effects include diarrhea, nausea, headache, and common cold. If you experience these or other symptoms, talk to your doctor. Do not stop taking PREZISTA or any other medications without first talking to your doctor.

PREZISTA should always be taken twice a day with and at the same time as 100 mg ritonavir (Norvir®), in combination with other anti-HIV medicines as prescribed by your doctor. PREZISTA should also be taken with food (the type of food is not important).

Please see the full Product Information in PDF format for more details.