LYCOS RETRIEVER 
Prograf: Patients
built 606 days ago
Prograf-based immunosuppression following kidney transplantation was assessed in a Phase III randomized, multicenter, non-blinded, prospective study. There were 412 kidney transplant patients enrolled at 19 clinical sites in the United States. Study therapy was initiated when renal function was stable as indicated by a serum creatinine </= 4 mg/dL (median of 4 days after transplantation, range 1 to 14 days). Patients less than 6 years of age were excluded.
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There were 205 patients randomized to Prograf-based immunosuppression and 207 patients were randomized to cyclosporine-based immunosuppression. All patients received prophylactic induction therapy consisting of an antilymphocyte antibody preparation, corticosteroids and azathioprine. Overall 1year patient and graft survival was 96.1% and 89.6%, respectively and was equivalent between treatment arms.
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Prograf concentrate for infusion contains polyoxyethylene hydrogenated castor oil, which has been reported to cause anaphylactoid reactions. These reactions consist of flushing of the face and upper thorax, acute respiratory distress with dyspnoea and wheezing, blood pressure changes and tachycardia. Caution is therefore necessary in patients who have previously received, by intravenous injection or infusion, preparations containing polyoxyethylated castor oil and in patients with an allergenic predisposition. Animal studies have shown that the risk of anaphylaxis may be reduced by slow infusion of Prograf or by the prior administration of an antihistamine. Prograf capsules 1 mg and 5 mg do not contain polyoxyethylene hydrogenated castor oil.
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Prograf can cause neurotoxicity and nephrotoxicity, particularly when used in high doses. Nephrotoxicity was reported in approximately 52% of kidney transplantation patients and in 40% and 36% of liver transplantation patients receiving Prograf in the U.S. and European randomized trials, respectively, and in 59% of heart transplantation patients in a European randomized trial (see ADVERSE REACTIONS). Use of Prograf with sirolimus in heart transplantation patients in a US study was associated with increased risk of renal function impairment, and is not recommended (See CLINICAL STUDIES). More overt nephrotoxicity is seen early after transplantation, characterized by increasing serum creatinine and a decrease in urine output. Patients with impaired renal function should be monitored closely as the dosage of Prograf may need to be reduced. In patients with persistent elevations of serum creatinine who are unresponsive to dosage adjustments, consideration should be given to changing to another immunosuppressive therapy.
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The FDA's review of Prograf for use in heart transplant patients was based on two open-label, randomized, comparative clinical studies -- one U.S-based study, and one European-based study. The studies represented a total of 645 heart transplant recipients and evaluated the safety and efficacy of Prograf- based vs. cyclosporine-based immunosuppression in primary orthotopic heart transplantation.
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Prograf is associated with many and various side effects. These include baldness (which can occur in 1 in 5 patients who take it), anemia (1 in 2), loss of appetite (1 in 3), diarrhea (3 of 4), high concentrations of potassium in the blood (1 in 2), high blood pressure (1 in 2), nausea (1 in 2), vomiting (1 in 4), tingling sensation in the extremities (2 in 5), itching (1 in 3), tremor (1 in 2), fever (1 in 2), headache (2 in 3), rash (1 in 4), high blood sugar concentrations (between 1 in 3 and 1 in 2), and abdominal pain (1in 4). Other side effects may include confusion, painful joints, increased sensitivity to light, blurred vision, insomnia, infection, jaundice (yellowing of the skin due to effects on the liver), kidney injury, swollen ankles, and seizures.
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