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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, loss of appetite, or tiredness.
• 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. 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 people taking PREZISTA® and raltegravir together than with either drug separately, but was generally mild.

Who should not take PREZISTA®?

Do not take PREZISTA® with any medicine that contains: alfuzosin, cisapride, colchicine (if you have liver or kidney problems), dronedarone, elbasvir and grazoprevir, ergot-containing medicines (dihydroergotamine, ergotamine tartrate, methylergonovine), ivabradine, lomitapide, lovastatin, lurasidone, midazolam (when taken by mouth), naloxegol, pimozide, ranolazine, rifampin, sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH), simvastatin, St. John's wort (Hypericum perforatum), or triazolam.

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

What should I tell my healthcare provider before taking PREZISTA®?

Before taking PREZISTA®, tell your healthcare provider if you:

• have liver problems (including hepatitis B or C), allergy to sulfa medicines, high blood sugar (diabetes), hemophilia, or any other medical conditions.
• are pregnant or planning to become pregnant. Tell your healthcare provider if you become pregnant while taking PREZISTA®.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take PREZISTA®. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. It is not known if PREZISTA® can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicine, vitamins, and herbal supplements. Some medicines interact with PREZISTA®. Keep a list of your medicines to show your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.

What are the possible side effects of PREZISTA®?

PREZISTA® may cause serious side effects, including:

• 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 can happen in people who take HIV medicines. The exact cause and long-term health effects of these conditions are not known.
• 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 in your body for a long time.

The most common side effects of PREZISTA® include diarrhea, nausea, rash, headache, stomach pain, and vomiting.

These are not all the possible side effects of PREZISTA®. For more information, ask your healthcare provider. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Do not change your dose or stop treatment with PREZISTA® without 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. You may also report side effects to Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736).

Please refer to the NORVIR® (ritonavir) Patient Information Leaflet for additional information on precautionary measures.

Please read full Product Information for PREZISTA® for more details.

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