LYCOS RETRIEVER 
Prograf: Oral Prograf
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Prograf is a drug that suppresses the immune system and is used to prevent rejection of transplanted organs. Prograf accomplishes its immune-suppressing effecting by inhibiting an enzyme (calcineurin) crucial for the multiplication of T-cells, cells that are vital to the immune process. The use of oral Prograf allows transplantation specialists to reduce the dose of steroids which are ... used to prevent rejection. This "steroid-sparing effect" is important because of the many side effects that can occur when larger doses of steroids are used for a long period of time. Prograf was approved by the FDA in April, 1994 for liver transplantation and also has been used in patients for heart, kidney, small bowel, and bone marrow transplantation.
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Absorption of Prograf, following oral administration can be rapid (within 0.5 hours) or can occur continually over a prolonged period of time, resulting in a relatively flat absorption profile. The absorption of Prograf is reduced when taken with food, and it is recommended that capsules be taken on an empty stomach or at least an hour before a meal. The mean oral bioavailability was estimated to be approximately 20% in liver and kidney transplant patients. Bile does not influence the absorption of Prograf, and therefore commencement of therapy with an oral dose, and early conversions to oral therapy are both possible.
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Oral Prograf is taken twice daily. Doses vary widely and are based on blood tests that measure the amount of Prograf in the body. Taking Prograf with food can reduce some of the abdominal pain that can occur with this medicine; ... food can reduce the amount of Prograf that is absorbed. This is especially true with fatty foods. Thus, Prograf is best taken without food. If it must be taken with food, it should be taken with non-fatty food.
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One-year patient survival and graft survival in the Prograf-based treatment groups were equivalent to those in the CBIR treatment groups in both studies. The overall 1-year patient survival (CBIR and Prograf-based treatment groups combined) was 88% in the U.S. study and 78% in the European study. The overall 1-year graft survival (CBIR and Prograf-based treatment groups combined) was 81% in the U.S. study and 73% in the European study. In both studies, the median time to convert from IV to oral Prograf dosing was 2 days.
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Prograf is highly bound to red blood cells and to plasma proteins and distribution is extensive. After oral administration, steady-state concentrations of Prograf were achieved within 3 days in most patients. The half-life of Prograf varies between 3.5 and 40.5 hours. In liver transplant patients, the elimination half-life based on the whole blood concentration averaged 11.7 hours. Renal clearance is less than 1 mL/min. Tacrolimus trough concentrations from 10 - 60 ng/mL measured at 10 - 12 hours post dose correlated well with the AUC plasma or whole blood.
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Prograf is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf injection should be reserved for patients unable to take Prograf capsules orally. In heart transplant recipients, it is recommended that Prograf be used in conjunction with azathioprine or mycophenolate mofetil (MMF). The safety and efficacy of the use of Prograf with sirolimus has not been established (see CLINICAL STUDIES).
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Oral Prograf