FDA Approves New 800mg PREZISTAÂ® (darunavir) Tablet
TITUSVILLE, N.J., Nov. 9, 2012 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration (FDA) has approved a new 800mg tablet of PREZISTA ® (darunavir) for once daily oral administration for the treatment of human immunodeficiency virus (HIV-1) in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations. PREZISTA ® is always taken with and at the same time as ritonavir with food and in combination with other HIV medicines.
The new tablet strength will allow patients taking PREZISTA ® once daily to reduce the number of PREZISTA ® tablets by half, taking one 800mg tablet instead of two 400mg tablets once a day with ritonavir 100mg and other antiretroviral medications.
The 800mg tablet is expected to be available shortly. Janssen plans to discontinue the PREZISTA ® 400mg tablet, which will become obsolete as a result of the introduction of the 800mg tablet. To help physicians and patients transition to the new tablet, Janssen will provide educational materials about the new tablet to pharmacies. PREZISTA ® 800mg tablets will be added to medicines covered by the Janssen Therapeutics Patient Savings Program as well as those covered by the Johnson & Johnson Patient Assistance Foundation."The single 800mg tablet provides an option for a reduced pill burden and reflects our ongoing commitment to offer more treatment options for the diverse population of people living with HIV," said Bryan Baugh, MD, Medical Director at Janssen Therapeutics. 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.
- 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 ® 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 professional should do blood tests before and during your combination treatment with 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
- Tell your healthcare professional 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 professional immediately if you develop a rash. However, stop taking PREZISTA ® and ritonavir combination treatment and call your healthcare professional 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
- Do not take PREZISTA ® if you are taking the following medicines: alfuzosin (Uroxatral ®), dihydroergotamine (D.H.E.45 ®, Embolex ®, Migranal ®), ergonovine, ergotamine (Cafergot ®, Ergomar ®), methylergonovine, cisapride (Propulsid ®), pimozide (Orap ®), oral midazolam, triazolam (Halcion ®), the herbal supplement St. John's wort (Hypericum perforatum), lovastatin (Mevacor ®, Altoprev ®, Advicor ®), 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 professional 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 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
- Before taking PREZISTA ®, tell your healthcare professional if you have any medical conditions, including liver problems (including hepatitis B or C), allergy to sulfa medicines, diabetes, 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. 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
- 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 professional. Do not stop taking PREZISTA ® or any other medicines without first talking to your healthcare professional
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