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U.S. Department of Health and Human Services

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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Astellas
 
NNPS:  FALSE
 
Therapeutic Category:  Immunologic agent
 
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