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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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