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Do not take CRIXIVAN® (indinavir sulfate) if you have had a serious allergic reaction to CRIXIVAN or any of its components.
Some patients treated with CRIXIVAN developed kidney stones. For some, this leads to more severe kidney problems, including kidney failure, inflammation of the kidneys, or kidney infection, which sometimes spreads to the blood. Drinking at least six 8-ounce glasses of liquid (preferably water) each day should help reduce the chance of forming a kidney stone.
Also, some patients experienced rapid breakdown of red blood cells (hemolytic anemia), which in some cases was severe or resulted in death; some had liver problems, including liver failure and death.
Diabetes and high blood sugar (hyperglycemia) have occurred in patients taking protease inhibitors. In some of these patients, this led to ketoacidosis, a serious condition caused by poorly controlled blood sugar. Some patients had diabetes before starting protease inhibitors; others did not. Some patients required adjustments to their diabetes medication. Others needed new diabetes medication.
There have been reports of increased bleeding in patients with hemophilia A and B.
Severe muscle pain and weakness have occurred in patients taking protease inhibitors, including CRIXIVAN, together with some of the cholesterol-lowering medicines called “statins.” Call your doctor if you develop severe muscle pain or weakness.
Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term effects of these conditions are not known at this time.
Increases in bilirubin (one laboratory test of liver function) have occurred in approximately 14% of patients, and, on rare occasions, a patient may develop yellowing of the skin and/or eyes.
Side effects occurring in 2% or more of patients included abdominal pain, fatigue or weakness, low red blood cell count, flank pain, painful urination, feeling unwell, nausea, upset stomach, diarrhea, vomiting, acid regurgitation, increased or decreased appetite, back pain, headache, dizziness, taste changes, rash, itchy skin, yellowing of the skin and/or eyes, upper respiratory infection, dry skin, and sore throat.
Other side effects reported since CRIXIVAN has been marketed include allergic reactions; severe skin reactions; yellowing of the skin and/or eyes; heart problems, including heart attack; stroke; abdominal swelling; indigestion; inflammation of the kidneys; inflammation of the pancreas; joint pain; depression; itching; hives; change in skin color; hair loss; ingrown toenails with or without infection; crystals in the urine; painful urination; numbness of the mouth; and increased cholesterol.
For additional information about CRIXIVAN, please read the Patient Product Information.
The physician Prescribing Information is also available.
