Bottles of 100                                                                                     NDC 55111-527-01

Bottles of 500                                                                                     NDC 55111-527-05

Unit Dose Package of 100 (10 x 10)                                                  NDC 55111-527-78
Note: Tacrolimus capsules are not filled to maximum capsule capacity. Capsule contains labeled amount.
Store and Dispense
Store Tacrolimus capsules at 20°C-25°C (68°F-77°F) [See USP Controlled Room Temperature].
Patient Counseling Information
17.1 Administration
Advise patients to:
•Take Tacrolimus at the same 12-hour intervals everyday to achieve consistent blood concentrations.
•Take Tacrolimus consistently either with or without food because the presence and composition of food decreases the bioavailability of Tacrolimus.
•Not to eat grapefruit or drink grapefruit juice in combination with Tacrolimus [seeDrug Interactions (7.2)].
17.2 Development of Lymphoma and Other Malignancies
Inform patients they are at increased risk of developing lymphomas and other malignancies, particularly of the skin, due to immunosuppression. Advise patients to limit exposure to sunlight and ultraviolet (UV) light by wearing protective clothing and use a sunscreen with a high protection factor [see Warnings and Precautions (5.2)].
17.3 Increased Risk of Infection
Inform patients they are at increased risk of developing a variety of infections, including opportunistic infections, du