August 24, 2016
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Astagraf XL

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Astagraf XL

Indications
Dosage
How Supplied

INDICATIONS

ASTAGRAF XL is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.

Limitation of Use

ASTAGRAF XL extended-release capsules are not interchangeable or substitutable with other tacrolimus extended-release or immediate-release products [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Administration Instructions

  • Take ASTAGRAF XL 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].
  • Swallow ASTAGRAF XL capsules whole with liquid; do not chew, divide, or crush the capsules.
  • If a dose is missed, take the dose up to 14 hours after the scheduled time (i.e., for a missed 8:00 AM dose, take by 10:00 PM). Beyond the 14-hour time frame, wait until the usual scheduled time the following morning to take the next regular daily dose.
  • Avoid eating grapefruit or drinking grapefruit juice or alcoholic beverage while taking ASTAGRAF XL [see DRUG INTERACTIONS].

Recommended Starting Dosage

Table 1 includes the recommended starting ASTAGRAF XL dosages. Due to the reduced clearance and prolonged half-life, patients with severe hepatic impairment (Child-Pugh ≥ 10) may require a lower starting dosage of ASTAGRAF XL [see CLINICAL PHARMACOLOGY].

Table 1: Recommended Starting Dosage of ASTAGRAF XL with or without Basiliximab Induction

Concomitant Medications Starting Dosages of ASTAGRAF XL
With MMF, steroids, and basiliximab induction Administer 0.15 to 0.2 mg/kg prior to reperfusion or within 48 hours of the completion of the transplant procedure (timing may be delayed until renal function has recovered).
With MMF and steroids; Without basiliximab induction
  • First Dose (pre-operative): Administer 0.1 mg/kg as a single dose within 12 hours prior to reperfusion.
  • Second Dose (post-operative): Administer 0.2 mg/kg at least 4 hours after the pre-operative dose and within 12 hours afterreperfusion.
MMF = mycophenolate mofetil

Dosage Adjustments

Titrate the ASTAGRAF XL dosage based on clinical assessments of rejection and tolerability and to achieve target trough concentration ranges (see Table 2) [see Therapeutic Drug Monitoring and WARNINGS AND PRECAUTIONS].

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 and Clinical Studies].

Table 2: Recommended Target Tacrolimus Whole Blood Trough Concentrations in Kidney Transplant Patients

Time Period Post Transplant Tacrolimus Target Whole Blood Trough Concentrations
During Month 1 7 to 15 ng/mL (with basiliximab induction) 10 to 15 ng/mL (without basiliximab induction)
Months 2 to 6 5 to 15 ng/mL
> 6 Months 5 to 10 ng/mL
For observed tacrolimus concentrations see Clinical Studies.

Therapeutic Drug Monitoring

Measure tacrolimus whole blood trough concentrations at least two times on separate days during the first week after initiation of dosing and after a change in dosage, after a change in co-administration of CYP3A4 inducers and/or inhibitors, or after a change in renal or hepatic function. When interpreting measured concentrations, consider that the time to achieve tacrolimus steady state is approximately 7 days after initiating or changing the ASTAGRAF XL dose.

Monitor tacrolimus whole blood trough concentrations using a validated assay [e.g., immunoassays or high-performance liquid chromatography with tandem mass spectrometric detection (HPLC/MS/MS)]. The immunosuppressive activity of tacrolimus is mainly due to the parent drug rather than to its metabolites. Immunoassays may react with metabolites as well as the parent drug. Therefore, whole blood tacrolimus trough concentrations obtained with immunoassays may be numerically higher than concentrations obtained with an assay using HPLC/MS/MS. Comparison of the whole blood tacrolimus trough concentrations of patients to those described in the prescribing information and other published literature must be made with knowledge of the assay method(s) employed.

HOW SUPPLIED

Dosage Forms And Strengths

ASTAGRAF XL Capsules
  • 0.5 mg: light yellow cap and orange body branded with red logo and “647” on the capsule body and “0.5 mg” on the capsule cap.
  • 1 mg: white cap and orange body branded with red logo and “677” on the capsule body and “1 mg” on the capsule cap.
  • 5 mg: grayish-red cap and orange body branded with red logo and “687” on the capsule body and “5 mg” on the capsule cap.

Storage And Handling

ASTAGRAF XL (tacrolimus) extended-release capsules are supplied in short, square bottles as well as in blister cartons (see Table 17).

Table 17: Strengths of ASTAGRAF XL

0.5 mg Oblong capsule with a light yellow cap and orange body. Capsule is branded with red logo and "647" on capsule body and "0.5 mg" on capsule cap. Both bottle and blister packaging are branded with matching brown stripes.
  • 30-count in short, square bottles with brown caps (NDC 0469-0647-73)
  • Blister cartons containing 5 blister cards of 10 capsules on each card (NDC 0469-0647-11).
1 mg Oblong capsule with a white cap and orange body. Capsule is branded with red and "677" on capsule body and "1 mg" on capsule cap. Both bottle and blister packagingare branded with matching blue stripes.
  • 30-count in short, square bottles with blue caps (NDC 0469-0677-73)
  • Blister cartons containing 5 blister cards of 10 capsules on each card (NDC 0469-0677-11).
5 mg Oblong capsule with a grayish-red cap and orange body. Capsule is branded with red and "687" on capsule body and "5 mg" on capsule cap. Both bottle and blister packaging are branded with matching orange stripes.
  • 30-count in short, square bottles with orange caps (NDC 0469-0687-73)
  • Blister cartons containing 5 blister cards of 10 capsules on each card (NDC 0469-0687-11).

Store And Dispense

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Manufactured by: Astellas Ireland Co., Limited Killorglin, County Kerry, Ireland. Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062. Revised: Dec 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/28/2015

Indications
Dosage
How Supplied

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