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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:  06/23/2008
 
Trade Name:  Aptivus
 
Generic Name or Proper Name (*):  tipranavir
 
Indications Studied:  Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor
 
Label Changes Summary:  Extended indication from adults to children 2 years and older The risk-benefit has not been established in patients <2 years of age Dosing is based on body weight or body surface area not to exceed adult dose Aes are generally similar to those seen in adults however, rash was more frequent in pediatric patients than in adults; The frequency of rash through 48 weeks of treatment was 21%. Most rashes were mild and 5% were moderate. Overall 3% interrupted treatment due to rash Information on dose, Aes, PK parameters, lab abnormalities, and clinical study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Boehringer Ingelheim
 
Pediatric Exclusivity Granted Date:  03/07/2008
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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