ENVARSUS XR- tacrolimus tablet, extended release
Veloxis Pharmaceuticals, Inc
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing serious infections and malignancies with ENVARSUS XR or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions (5.1, 5.2)].
1 INDICATIONS AND USAGE
ENVARSUS XR is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants.
Limitation of Use
ENVARSUS XR extended-release tablets are not interchangeable or substitutable with other tacrolimus extended-release or immediate-release products [see Warnings and Precautions (5.3)].
2 DOSAGE AND ADMINISTRATION
2.1 Administration Instructions
Take ENVARSUS XR on an empty stomach at the same time of the day, preferably in the morning (to ensure consistent and maximum possible drug exposure) [see Clinical Pharmacology (12.2)].
Swallow ENVARSUS XR whole with fluid (preferably water); do not chew, divide, or crush the tablets.
If a dose is missed, take it as soon as possible within 15 hours after missing the dose; beyond the 15-hour time frame, wait until the usual scheduled time to take the next regular daily dose. Do not double the next dose.
Avoid eating grapefruit or drinking grapefruit juice or alcoholic beverage while taking ENVARSUS XR [see Drug Interactions (7.2)].
African-American patients, compared to Caucasian patients, may need to be titrated to higher ENVARSUS XR dosages to attain comparable trough concentrations [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.2)].
2.2 Conversion from Tacrolimus Immediate-Release Formulations
To convert from a tacrolimus immediate-release product to ENVARSUS XR, administer an ENVARSUS XR once daily dose that is 80% of the total daily dose of the tacrolimus immediate-release product. Monitor tacrolimus whole blood trough concentrations and titrate ENVARSUS XR dosage to achieve target whole blood trough concentration ranges of 4 to 11 ng/mL.