ASTAGRAF XL

ASTAGRAF XL- tacrolimus capsule, coated, extended release
Astellas Pharma US, Inc.

WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS; AND INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS

Increased risk for developing serious infections and malignancies with ASTAGRAF XL® or other immunosuppressants that may lead to hospitalization or death. [see Warnings and Precautions (5.1, 5.2)]
Increased mortality in female liver transplant patients with ASTAGRAF XL. ASTAGRAF XL is not approved for use in liver transplantation. [see Warnings and Precautions (5.3)]

1 INDICATIONS AND USAGE

ASTAGRAF XL® is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact [see Use in Specific Populations (8.4) and Clinical Studies (14.1), (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

ASTAGRAF XL should not be used without the supervision by a physician with experience in immunosuppressive therapy.
ASTAGRAF XL (tacrolimus extended-release capsules) is not interchangeable or substitutable for tacrolimus extended-release tablets, tacrolimus immediate-release capsules or tacrolimus for oral suspension. Under or overexposure to tacrolimus may result in graft rejection or other serious adverse reactions. Changes between tacrolimus immediate-release and extended-release dosage forms must occur under physician supervision [see Warnings and Precautions (5.4)].
Advise patients to swallow ASTAGRAF XL capsules whole with liquid; patients must not chew, divide, or crush the capsules.
ASTAGRAF XL should be taken consistently every morning at the same time to ensure consistent and maximum possible drug exposure, on an empty stomach at least 1 hour before a meal, or at least 2 hours after a meal [see Clinical Pharmacology (12.3)].
If a dose is missed, the dose may be taken up to 14 hours after the scheduled time (i.e., for a missed 8:00 AM dose, a dose may be taken by 10:00 PM). Beyond the 14-hour time frame, the patient should wait until the usual scheduled time the following morning to take the next regular daily dose. Instruct the patient not to double the next dose.
Advise patients to avoid eating grapefruit or drinking grapefruit juice or alcoholic beverages while taking ASTAGRAF XL [see Drug Interactions (7.2)].
Therapeutic drug monitoring is recommended for all patients receiving ASTAGRAF XL [see Dosage and Administration (2.4)].

2.2 Dosing for Kidney Transplant Patients

Table 1 includes the recommended starting ASTAGRAF XL dosages and whole blood trough concentration ranges; the observed trough concentrations are shown in another section of the Full Prescribing Information [see Clinical Studies (14)]. Titrate the ASTAGRAF XL dosage based on clinical assessments of rejection and tolerability, and to achieve target trough concentration ranges [see Dosage and Administration (2.4) and Warnings and Precautions (5.6, 5.7, 5.10, 5.11)].

Table 1: Recommended Starting Daily Dosage Regimen of ASTAGRAF XL
MMF = mycophenolate mofetil

Recommended ASTAGRAF XL Initial Dosage*

Patient Population

Initial Oral Dosage

Whole Blood Trough Concentration Range

ADULT

With basiliximab, MMF and steroids

0.15 to 0.2 mg/kg once daily prior to reperfusion or within 48 hours of completion of transplant

• Month 1: 7-15 ng/mL

• Months 2-6: 5-15 ng/mL

• > 6 Months: 5-10 ng/mL

With MMF and steroids, without basiliximab induction

• First dose (pre-operative): 0.1 mg/kg, within 12 hours prior to reperfusion

• Subsequent doses (post-operative): 0.2 mg/kg once daily at least 4 hours after pre-operative dose and within 12 hours after reperfusion

• Month 1: 10-15 ng/mL

• Months 2-6: 5-15 ng/mL

> 6 Months: 5-10 ng/mL

PEDIATRIC

With basiliximab, MMF and steroids

0.3 mg/kg once daily, administered within 24 hours following reperfusion.

• Month 1: 10-20 ng/mL

• > Month 1: 5-15 ng/mL

2.3 Dosage Adjustments: African-American Patients, Patients with Hepatic Impairment, Drug Interactions

African-American patients, compared to Caucasian patients, may need to be titrated to higher ASTAGRAF XL dosages to attain comparable trough concentrations [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

Patients with severe hepatic impairment (Child-Pugh ≥ 10) may require a lower starting dosage of ASTAGRAF XL, due to the reduced clearance and prolonged half-life [see Clinical Pharmacology (12.3)].

Dose adjustments of ASTAGRAF XL may be necessary when administered concomitantly with CYP3A inducers or CYP3A inhibitors [see Warnings and Precautions (5.10) and Drug Interactions (7.2)].

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