Prograf (Page 12 of 12)

Liver Transplantation

Although there is a lack of direct correlation between tacrolimus concentrations and drug efficacy, data from Phase II and III studies of liver transplant patients have shown an increasing incidence of adverse events with increasing trough blood concentrations. Most patients are stable when trough whole blood concentrations are maintained between 5 to 20 ng/mL. Long-term post-transplant patients often are maintained at the low end of this target range.

Data from the U.S. clinical trial show that tacrolimus whole blood concentrations, as measured by ELISA, were most variable during the first week post-transplantation. After this early period, the median trough blood concentrations, measured at intervals from the second week to one year post-transplantation, ranged from 9.8 ng/mL to 19.4 ng/mL.

Therapeutic Drug Monitoring, 1995, Volume 17, Number 6 contains a consensus document and several position papers regarding the therapeutic monitoring of tacrolimus from the 1995 International Consensus Conference on Immunosuppressive Drugs. Refer to these manuscripts for further discussions of tacrolimus monitoring.

Kidney Transplantation

Data from a Phase 3 study of Prograf in conjunction with azathioprine indicate that trough concentrations of tacrolimus in whole blood, as measured by IMx® were most variable during the first week of dosing. During the first three months of that trial, 80% of the patients maintained trough concentrations between 7-20 ng/mL, and then between 5-15 ng/mL, through 1 year.

In a separate clinical trial of Prograf in conjunction with MMF and daclizumab, approximately 80% of patients maintained tacrolimus whole blood concentrations between 4-11 ng/mL through 1 year post-transplant.

In another clinical trial of Prograf in conjunction with MMF and basiliximab, approximately 80% of patients maintained tacrolimus whole trough blood concentrations between 6-16 ng/mL during month 1-3 and, then, between 5-12 ng/mL from month 4 through 1 year.

The relative risks of toxicity and efficacy failure are related to tacrolimus whole blood trough concentrations. Therefore, monitoring of whole blood trough concentrations is recommended to assist in the clinical evaluation of toxicity and efficacy failure.

Heart Transplantation

Data from a European Phase 3 study indicate that trough concentrations of tacrolimus in whole blood, as measured by IMx® were most variable during the first week of dosing. From 1 week to 3 months post transplant, approximately 80% of patients maintained trough concentrations between 8-20 ng/mL and, from 3 months through 18 months post transplant, approximately 80% of patients maintained trough concentrations between 6-18 ng/mL.

The relative risk of toxicity; for example, nephrotoxicity and post-transplant diabetes mellitus, is increased with higher trough concentrations. Therefore, monitoring of whole blood trough concentrations is recommended to assist in the clinical evaluation of toxicity.

HOW SUPPLIED

Prograf capsules (tacrolimus capsules)
strength

1 mg

(containing the equivalent of 1 mg anhydrous tacrolimus)

shape/color oblong/white
branding on capsule cap/body

f

100 count bottle NDC 21695-170-00

Made in Japan

Store and Dispense

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Prograf injection (tacrolimus injection)

(for IV infusion only)

NDC 0469-3016-01 Product Code 301601

5 mg/mL (equivalent of 5 mg of anhydrous tacrolimus per mL) supplied as a sterile solution in a 1 mL ampule, in boxes of 10 ampules

Made in Ireland

Store and Dispense

Store between 5°C and 25°C (41°F and 77°F).

Rx only

Marketed by:

Astellas Pharma US, Inc.

Deerfield, IL 60015-2548

Revised: August 2009

09H011PRG-CPI

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

REFERENCE

1.CDC: Recommendations of the Advisory Committee on Immunization Practices: Use of vaccines and immune globulins in persons with altered immunocompetence. MMWR 1993;42(RR-4):1-18.

Principal Display Panel

Prograf 1 mg
(click image for full-size original)

PROGRAF tacrolimus capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-170(NDC:0469-0617)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
anhydrous tacrolimus (tacrolimus) anhydrous tacrolimus 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
magnesium stearate
LACTOSE MONOHYDRATE
gelatin
titanium dioxide
Product Characteristics
Color WHITE (WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 11mm
Flavor Imprint Code f;617;1;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-170-00 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 100 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE This package is contained within the CARTON (21695-170-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050708 04/08/1994
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 12/2010 Rebel Distributors Corp

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