PREZISTA ^® (darunavir) is a prescription medicine. It is one treatment option in the class of HIV (human immunodeficiency virus) medicines known as protease inhibitors.

PREZISTA is always taken with and at the same time as ritonavir (Norvir ^® ), in combination with other HIV medicines for the treatment of HIV infection in adults. PREZISTA should also be taken with food.

• The use of other medicines active against HIV in combination with PREZISTA/ritonavir (Norvir ^® ) may increase your ability to fight HIV. Your healthcare professional will work with you to find the right combination of HIV medicines
• It is important that you remain under the care of your healthcare professional during treatment with PREZISTA

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 healthcare professional to learn if PREZISTA is right for you.

Important Safety Information

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

• PREZISTA, together with Norvir ^® , has rarely been observed to cause liver problems which may be life-threatening. It was not always clear if PREZISTA caused these liver problems because some patients had other illnesses or were taking other medicines. Your healthcare professional should do blood tests prior to starting combination treatment including PREZISTA. If you have chronic hepatitis B or C infection, your healthcare professional should check your blood tests more often because you have an increased chance of developing liver problems
  
  Talk to your healthcare professional about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea-colored) urine, pale-colored stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs
• Skin rashes have been reported in patients taking PREZISTA. Rarely, PREZISTA has been reported to cause a severe or life-threatening rash. Contact your healthcare professional immediately if you develop a rash. Your healthcare professional will advise you whether your symptoms can be managed on therapy or whether PREZISTA should be stopped

Can PREZISTA be taken with other medications?

• 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: alfuzosin (Uroxatral^® ), dihydroergotamine (D.H.E.45 ^® , Migranal ^® ), ergonovine, ergotamine (Wigraine ^® , Ergostat ^® , Cafergot ^® , Ergomar ^® ), methylergonovine, cisapride (Propulsid ^® ), pimozide (Orap ^® ), oral midazolam, triazolam (Halcion ^® ), rifampin (Rifadin ^® , Rifater ^® , Rifamate ^® ), sildenafil (Revatio ^® ) when used to treat pulmonary arterial hypertension, indinavir (Crixivan ^® ), lopinavir/ritonavir (Kaletra ^® ), saquinavir (Invirase ^® ), lovastatin (Mevacor ^® , Altoprev ^® , Advicor ^® ), pravastatin (Pravachol ^® ), simvastatin (Zocor ^® , Simcor ^® , Vytorin ^® ), salmeterol (Serevent ^® ), or products containing St. John's wort
• Before taking PREZISTA, tell your health care professional if you are taking sildenafil (Viagra ^® ), vardenafil (Levitra ^® ), tadalafil (Cialis ^® , Adcirca ^® ), atorvastatin (Lipitor ^® ), atorvastatin/amlodipine (Caduet ^® ), or rosuvastatin (Crestor ^® ), or colchicine (Colcrys ^® ). This is not a complete list of medicines. Be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements
• Tell your healthcare professional if you are taking estrogen-based contraceptives (birth control). PREZISTA might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control, such as condoms

What should I tell my doctor before I take PREZISTA?

• Before taking PREZISTA, tell your healthcare professional if you have any medical conditions, including allergy to sulfa medicines, diabetes, liver problems (including hepatitis B or C), or hemophilia
• Tell your healthcare professional 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 healthcare professional will need to decide if taking PREZISTA is right for you
  • Do not breastfeed if you are taking PREZISTA. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby

What are the possible side effects of PREZISTA?

• High blood sugar, diabetes or worsening of diabetes, and increased bleeding in people with hemophilia have been reported in patients taking protease inhibitor medicines, including PREZISTA
• Changes in body fat have been seen in some patients taking HIV medicines, including PREZISTA. 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 related to taking PREZISTA include diarrhea, nausea, rash, headache, stomach pain, and vomiting. Uncommon but severe side effects such as inflammation of the pancreas and increased blood fat levels have also been rarely reported. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare professional. Do not stop taking PREZISTA or any other medicines without first talking to your healthcare professional

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please refer to the ritonavir (Norvir ^® ) Product Information (PI and PPI) for additional information on precautionary measures

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