PREZISTA® Side Effects

PREZISTA® Side Effects

What are the possible side effects of PREZISTA®?

It’s important to understand the possible side effects you may experience when taking PREZISTA® (darunavir) with other HIV medicines. Your healthcare provider may help you manage some of the side effects that you may experience. Some side effects are more serious than others.

  • PREZISTA® can interact with other medicines and cause serious side effects. See "Who should not take PREZISTA®?"
  • PREZISTA® may cause liver problems. Some people taking PREZISTA®, together 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 these 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, or loss of appetite
  • PREZISTA® may cause a severe or life-threatening skin reaction 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 these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild

The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. Other important severe side effects include inflammation of the liver or pancreas and increased blood fat levels, diabetes, and changes in body fat.

Other possible side effects of Protease Inhibitors (PIs), including PREZISTA®

Some other side effects sometimes seen in patients taking PIs, including PREZISTA®, are:

  • High blood sugar, diabetes, or worsening of diabetes
  • More bleeding in people with hemophilia
  • Changes in body fat
    • The cause and long-term effects of increased body fat are not known at this time
  • Changes in your immune system
    • 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
    • If you notice swelling, tenderness, or redness, it is important that you tell your healthcare provider

Important Safety Information

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

  • PREZISTA® can interact with other medicines and cause serious side effects. See “Who should not take PREZISTA®?”
  • PREZISTA® may cause liver problems. Some people taking PREZISTA®, together 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 these 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, or loss of appetite

About PREZISTA®

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.

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®.

Please read Important Safety Information below, and talk to your healthcare provider to learn if PREZISTA® is right for you.

  • 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 these symptoms: fever, tiredness, muscle or joint pain, blisters or skin lesions, mouth sores or ulcers, red or inflamed eyes, like “pink eye.” Rash occurred more often in patients taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild

Who should not take PREZISTA®?

  • Do not take PREZISTA® if you are taking the following medicines: alfuzosin (Uroxatral®), dihydroergotamine (D.H.E.45®, Embolex®, Migranal®), ergotamine (Cafergot®, Ergomar®), methylergonovine, cisapride (Propulsid®), pimozide (Orap®), oral midazolam (Versed®), triazolam (Halcion®), the herbal supplement St. John's wort (Hypericum perforatum), lovastatin (Mevacor®, Altoprev®, Advicor®), salmeterol (Advair®, Serevent®), simvastatin (Zocor®, Simcor®, Vytorin®), rifampin (Rifadin®, Rifater®, Rifamate®, Rimactane®), sildenafil (Revatio®) when used to treat pulmonary arterial hypertension, indinavir (Crixivan®), lopinavir/ritonavir (Kaletra®), saquinavir (Invirase®), boceprevir (Victrelis®), or telaprevir (Incivek®)
  • Before taking PREZISTA®, tell your healthcare provider if you are taking sildenafil (Viagra®, Revatio®), vardenafil (Levitra®, Staxyn®), tadalafil (Cialis®, Adcirca®), atorvastatin (Lipitor®), rosuvastatin (Crestor®), pravastatin (Pravachol®), or colchicine (Colcrys®, Col-Probenecid®). Tell your healthcare provider 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

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

This is not a complete list of medicines. Be sure to tell your healthcare provider about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start any new medicines while you are taking PREZISTA® without first talking to your healthcare provider.

What should I tell my doctor before I take PREZISTA®?

  • Before taking PREZISTA®, tell your healthcare provider if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, or hemophilia
  • Tell your healthcare provider 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 provider will need to decide if taking PREZISTA® is right for you
    • Do not breastfeed. It is not known if PREZISTA® can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV should not breastfeed because HIV can be passed to your baby in the breast milk

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
  • Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden
  • The most common side effects related to taking PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting. This is not a complete list of all possible side effects. If you experience these or other side effects, talk to your healthcare provider. Do not stop taking PREZISTA® or any other medicines without first talking to your healthcare provider

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 accompanying full Product Information for more details.