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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
11/29/2018
Trade Name:
Astagraf XL
Generic Name or Proper Name (*):
tacrolimus
Indications Studied:
Prophylaxis of organ rejection in kidney transplant patients, in combination with other immunosuppressants.
Label Changes Summary:
*Safety and effectiveness of Astagraf XL in de novo pediatric kidney transplant patients have been established. *Use in pediatric kidney transplant patients is based on adequate and well controlled studies of Astagraf XL in adult kidney transplant patients and supported by pharmacokinetic and safety data in pediatric transplant patients 4 years of age and older who are able to swallow capsules intact and Prograf (tacrolimus) capsules in adult and pediatric transplant patients. *A pharmacokinetic and safety study included 25 de novo pediatric kidney transplant patients, 4 to 15 years of age, randomized and treated with either Prograf (n=12) or Astagraf XL (n=13). *Another pharmacokinetic and safety study included 48 stable pediatric kidney transplant patients, 5 to 16 years of age, who were converted from a Prograf-based regimen to Astagraf XL. *Information on dosing, clinical trials, adverse reactions and PK parameters. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Astellas
NNPS:
FALSE
Therapeutic Category:
Immunologic agent
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