tacrolimus capsule
1 INDICATIONS AND USAGE Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney or heart transplants, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )] , liver transplant [see Clinical Studies ( 14.2 )] and heart transplant [see Clinical Studies ( 14.3 )] , and pediatric patients receiving allogeneic liver transplants [see Clinical Studies ( 14.2 )] in combination with other immunosuppressants. Additional pediatric use and lung transplant information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
glenmark pharmaceuticals inc., usa
CAPSULE WHITE G 686
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Tacrolimus 0.5 mg
glenmark pharmaceuticals inc., usa
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1
TACROLIMUS capsules, USP
TACROLIMUS capsules, USP are available as follows: 0.5 mg: Size “4” hard gelatin capsule with light yellow cap and light yellow body, imprinted with a Glenmark logo “G” on the cap and “685” on the body in red ink, filled with white to off-white granular powder. Bottles of 100 with child-resistant closure, NDC 68462-685-01 1 mg: Size “4” hard gelatin capsule with white cap and white body, imprinted with a Glenmark logo “G” on the cap and “686” on the body in red ink, filled with white to off-white granular powder. Bottles of 100 with child-resistant closure, NDC 68462-686-01 Cartons of 100 (10 x 10 unit-dose), NDC 68462-686-14 5 mg: Size “4” hard gelatin capsule with greyish red cap and greyish red body, imprinted with a Glenmark logo “G” on the cap and “687” on the body in white ink, filled with white to off-white granular powder. Bottles of 100 with child-resistant closure, NDC 68462-687-01 Cartons of 100 (10 x 10 unit-dose), NDC 68462-687-14 Note:
TACROLIMUS capsules, USP are not filled to maximum capsule capacity. capsule contains labeled amount. Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. 16.4 Handling and Disposal
TACROLIMUS can cause fetal harm.
TACROLIMUS capsules should not be opened or crushed. Wearing disposable gloves is recommended during dilution of the injection in the hospital and when wiping any spills. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in
TACROLIMUS capsules. If such contact occurs, wash the skin thoroughly with soap and water; if ocular contact occurs, rinse eyes with water. In case a spill occurs, wipe the surface with a wet paper towel. Follow applicable special handling and disposal procedures 1 .
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