普樂可復®
0.5mg
1mg
5mg
Injection
新普樂可復®
0.5mg
此產品包裝盒的兩面分別印有中文及英文的標籤
1mg
此產品包裝盒的兩面分別印有中文及英文的標籤
5mg
此產品包裝盒的兩面分別印有中文及英文的標籤
Indication
Important Safety Information
- Prograf® (tacrolimus capsules and injection) 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 and kidney 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 have 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.
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 22% 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 wound healing complications, renal function impairment, and insulin-dependent post-transplant diabetes, and is not recommended.
- Mild to severe hyperkalemia was reported in 31% of kidney transplant recipients, 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, was 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 with 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.
- In postmarketing experience, patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES). If PRES is suspected or diagnosed, immediate reduction of immunosuppression is advised. Activation of latent viral infections, including BK virus–associated nephropathy and JC virus–associated progressive multifocal leukoencephalopathy (PML), have also been reported. These viral infections may lead to serious, including fatal, outcomes.
- The principal adverse reactions of Prograf include tremor, headache, hypertension, gastrointestinal disturbance, abnormal renal function, hyperglycemia, leukopenia, CMV infection, infection, and hyperlipemia.
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Prograf® (tacrolimus) was discovered in 1984 by Fujisawa scientists in Tsukuba, Japan. It is classified as a macrolide and has demonstrated potent in vitro and in vivo immunosuppressive activity. Studies conducted in the United States and Europe have confirmed its clinical effectiveness and relative safety for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney, or heart transplants.
Since Prograf was approved for the prophylaxis of organ rejection in liver transplant recipients in 1994, in kidney transplant recipients in 1997, and in heart transplant recipients in 2006, it has helped improve the success of transplantation—many patients continue to share their stories of success today. Such personal patient stories, coupled with long-term clinical trial results, have made evident the essential role Prograf plays in protecting patients for the years ahead.
Through Transplant Experience, patients are encouraged to maintain an open dialogue with their healthcare providers about key topics impacting post-transplant health. When patients join the program, they will receive a series of award-winning materials to help them understand their treatment and how to successfully manage their long-term health. A sampling of Transplant Experience materials has been compiled here for your reference.
The Patient Assistance Program (PAP) for Prograf is available to people who are uninsured, and those who are insured but have limited financial resources and obtaining Prograf is a significant financial hardship.
Since Prograf was approved for the prophylaxis of organ rejection in liver transplant recipients in 1994, in kidney transplant recipients in 1997, and in heart transplant recipients in 2006, it has helped improve the success of transplantation—many patients continue to share their stories of success today. Such personal patient stories, coupled with long-term clinical trial results, have made evident the essential role Prograf plays in protecting patients for the years ahead.
Booklets
The following booklets are Adobe® Portable Document Format (PDF) files. To open them on your computer, you will need Adobe® Reader®. Please click on the icon to download this program for free.
Helping Those With Significant Financial Need
Astellas is committed to helping ensure that patients have access to the Prograf® (tacrolimus) therapy prescribed to them. And for more than 10 years, the makers of Prograf have helped several thousand patients in financial need.The Patient Assistance Program (PAP) for Prograf is available to people who are uninsured, and those who are insured but have limited financial resources and obtaining Prograf is a significant financial hardship.
Through the PAP, patients may be eligible to receive Prograf free of charge if they:
The dosing recommendations presented below are guidelines. Dosing should be adjusted based on clinical assessments of rejection and tolerability. The relative risk of toxicity—for example, nephrotoxicity and new-onset diabetes mellitus—is increased with higher trough concentrations. Monitoring of whole blood trough concentrations is considered an essential aid to patient management for the evaluation of rejection, toxicity, dose adjustments, and adherence.
*Note: two divided doses, q12h
Lower doses of Prograf may be sufficient as maintenance therapy. Adjunct therapy with adrenal corticosteroids is recommended early post-transplant.
The recommended starting oral dose of Prograf is 0.2 mg/kg/day administered every 12 hours in 2 divided doses. The initial dose of Prograf may be administered within 24 hours of transplantation, but should be delayed until renal function has recovered (as indicated, for example, by a serum creatinine ≤4 mg/dL). Black patients may require higher doses to achieve comparable blood concentrations.
It is recommended that patients initiate oral therapy with Prograf capsules if possible. If IV therapy is necessary, conversion from IV to oral Prograf is recommended as soon as oral therapy can be tolerated. This usually occurs within 2 to 3 days.
The initial dose of Prograf should be administered no sooner than 6 hours after transplantation. In a patient receiving an IV infusion, the first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion. The recommended starting oral dose of Prograf capsules is 0.10 to 0.15 mg/kg/day administered in 2 divided daily doses every 12 hours.
The recommended starting oral dose of Prograf is 0.075 mg/kg/day administered every 12 hours in 2 divided doses. If possible, initiating oral therapy with Prograf capsules is recommended. If IV therapy is necessary, conversion from IV to oral Prograf is recommended as soon as oral therapy can be tolerated. This usually occurs within 2 to 3 days. The initial dose of Prograf should be administered no sooner than 6 hours after transplantation. In a patient receiving an IV infusion, the first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion.
Prograf should not be used simulataneously with cyclosporine. Prograf or cyclosporine should be discountinued at least 24 hours before initiating the other. In the presence of elevated Prograf or cyclosporine concentrations, dosing with the other drug usually should be further delayed.
Contact us to meet with an Astellas Immunology Healthcare Specialist (IHS). Our IHSs are an excellent resource for addressing clinical challenges in transplantation and optimizing treatment with Prograf. Contact an IHS assigned to your area today.
For additional questions about the safety and proper use of Prograf, please contact Astellas Medical Information.
Customer Service: 1-800-888-7704
Mailing Address
Astellas Pharma US, Inc.
Three Parkway North
Deerfield, IL 60015-2548
Product Complaints
Phone: 1-800-327-6449
Fax: 1-847-317-1249
Email: APUS_Product_Complaints@us.astellas.com
Astellas Reimbursement Services
1-800-477-6472
Monday through Friday
9 am to 8 pm ET
- Are not eligible for, or have been dropped from, Medicare, Medicaid, or private insurance
- Meet other criteria for eligibility, including residency and household income requirements
| Summary of Initial Oral Dosage Recommendations and Typical Whole Blood Trough Concentrations |
| Patient Population | Recommended Initial Oral Dose* |
Typical Whole Blood Trough Concentrations |
| Adult kidney transplant patients |
0.2 mg/kg/day | month 1-3: 7-20 ng/mL month 4-12: 5-15 ng/mL |
| Adult liver transplant patients |
0.10-0.15 mg/kg/day | month 1-12: 5-20 ng/mL |
| Pediatric liver transplant patients |
0.15-0.20 mg/kg/day | month 1-12: 5-20 ng/mL |
| Adult heart transplant patients |
0.075 mg/kg/day | month 1-3: 10-20 ng/mL month ≥4 5-15ng/mL |
Lower doses of Prograf may be sufficient as maintenance therapy. Adjunct therapy with adrenal corticosteroids is recommended early post-transplant.
The initial dose of Prograf should be administered no sooner than 6 hours after transplantation. In a patient receiving an IV infusion, the first dose of oral therapy should be given 8 to 12 hours after discontinuing the IV infusion. The recommended starting oral dose of Prograf capsules is 0.10 to 0.15 mg/kg/day administered in 2 divided daily doses every 12 hours.
For additional questions about the safety and proper use of Prograf, please contact Astellas Medical Information.
Customer Service: 1-800-888-7704
Mailing Address
Astellas Pharma US, Inc.
Three Parkway North
Deerfield, IL 60015-2548
Product Complaints
Phone: 1-800-327-6449
Fax: 1-847-317-1249
Email: APUS_Product_Complaints@us.astellas.com
Astellas Reimbursement Services
1-800-477-6472
Monday through Friday
9 am to 8 pm ET
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