PROGRAF tacrolimus capsules and injection

A number of organizations provide excellent online resources for information about transplantation. For your convenience, a listing of these websites is featured below:

American Heart Association (AHA)
AHA is a national voluntary health agency dedicated to reducing disability and death from cardiovascular diseases and stroke.

American Society of Nephrology (ASN)
ASN provides a forum for the promulgation of research, and meets the professional and continuing education needs of its members.

International Society for Heart & Lung Transplantation (ISHLT)
ISHLT, a not-for-profit organization, is dedicated to the advancement of the science and treatment of end-stage heart and lung diseases.

International Transplant Nurses Society (ITNS)
ITNS promotes excellence in transplant clinical nursing by providing educational and professional growth opportunities, interdisciplinary networking and collaborative activities, and transplant nursing research.

NATCO, The Organization for Transplant Professionals
NATCO supports, develops, and advances the knowledge of its members and influences the effectiveness, quality, and integrity of donation and transplantation. NATCO publishes a bimonthly newsletter, In Touch, as well as Progress in Transplantation, a journal for procurement and clinical transplant professionals.

National Kidney Foundation (NKF)
NKF is a major voluntary health organization seeking to prevent kidney and urinary tract diseases, improve the health and well-being of individuals and families affected by these diseases, and increase the availability of all organs for transplantation.

Transplant Recipients International Organization (TRIO)
TRIO is an international organization committed to improving the quality of life of transplant candidates, recipients, their families, and the families of organ and tissue donors. Through the TRIO headquarters and a network of local chapters, TRIO serves its members in the areas of awareness, support, education, and advocacy.

TransWeb: All About Transplantation and Donation
TransWeb features news and events, real people's experiences, the top 10 myths about organ donation, a donation quiz, and a large collection of questions and answers, as well as a reference area with everything from articles to videos.

United Network for Organ Sharing (UNOS)
UNOS administers the Organ Procurement and Transplantation Network (OPTN), the national organ-sharing system established in 1984 by the US Congress. OPTN maintains the only nationwide patient waiting list and works to link all professionals involved in organ donation and transplantation.

The information provided on this website is intended for residents of the United States

Indication

Prograf^® (tacrolimus) 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. The safety and efficacy of the use of Prograf with sirolimus has not been established.

Important Safety Information

WARNING
Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Prograf. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Prograf is contraindicated in patients with a hypersensitivity to tacrolimus. Prograf injection is contraindicated in patients with a hypersensitivity to castor oil. Patients receiving Prograf injection should be under continuous observation for at least the first 30 minutes following the start of infusion and at frequent intervals thereafter. If signs or symptoms of anaphylaxis occur, the infusion should be stopped.
Insulin-dependent post-transplant diabetes mellitus was reported in 11% to 20% of Prograf-treated liver, kidney, and heart transplant patients with no prior history of diabetes mellitus. Black and Hispanic kidney transplant patients were at increased risk. Insulin dependence was reversible in 15% to 45% of patients at 1 year.
Prograf has been associated with nephrotoxicity, particularly when used in high doses. In particular, to avoid excess nephrotoxicity, Prograf should not be used simultaneously with cyclosporine. Prograf or cyclosporine should be discontinued at least 24 hours prior to initiating the other. In the presence of elevated Prograf or cyclosporine concentrations, dosing with the other drug usually should be further delayed. Use of Prograf with sirolimus in heart transplant patients in a US study was associated with increased risk of renal function impairment and is not recommended.
Mild to severe hyperkalemia was reported in 31% of kidney transplant recipients and in 45% and 13% of liver transplant recipients in the US and European randomized trials, respectively, and in 8% of heart transplant recipients in a European randomized trial and may require treatment. Serum potassium levels should be monitored and potassium-sparing diuretics should not be used during Prograf therapy (see PRECAUTIONS).
Neurotoxicity, including tremor, headache, and other changes in motor function, mental status, and sensory function were reported in approximately 55% of liver transplant recipients in the two randomized studies. Tremor occurred more often in Prograf-treated kidney transplant (54%) and heart transplant patients (15%) compared to cyclosporine-treated patients. Seizures have occurred in adult and pediatric patients receiving Prograf. Coma and delirium also have been associated with high plasma concentrations of tacrolimus.
The principal adverse reactions of Prograf include tremor, headache, hypertension, gastrointestinal disturbance, abnormal renal function, hyperglycemia, leukopenia, CMV infection, infection, and hyperlipemia.