Clinical experience with intravenous zanamivir under an Emergency IND program in the United States (2011-2014)

Antiviral Therapy

Volumn 20, Issue 5, 2015, Pages 561-564

  Chan Tack, Kirk M ^a   Kim, Christine ^a   Moruf, Alicia ^a   Birnkrant, Debra B ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

OSELTAMIVIR; ZANAMIVIR; ANTIVIRUS AGENT;

2009 H1N1 INFLUENZA; ADOLESCENT; ADULT; ARTIFICIAL VENTILATION; BACTEREMIA; CHILD; COMORBIDITY; CRITICALLY ILL PATIENT; DATA BASE; DESCRIPTIVE RESEARCH; DISEASE EXACERBATION; DISEASE SEVERITY; DRUG APPROVAL; DRUG EFFICACY; DRUG SAFETY; EXTRACORPOREAL OXYGENATION; FEMALE; FOOD AND DRUG ADMINISTRATION; HIGH FREQUENCY VENTILATION; HUMAN; INFANT; INFLUENZA; INFLUENZA A; INFLUENZA A (H3N2); INFLUENZA B; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MORTALITY; NEWBORN; PNEUMONIA; PREGNANT WOMAN; PRIORITY JOURNAL; RENAL REPLACEMENT THERAPY; RETROSPECTIVE STUDY; REVIEW; SHOCK; SURVIVAL RATE; UNITED STATES; UNSPECIFIED SIDE EFFECT; AGED; DRUG EFFECTS; INFLUENZA A VIRUS (H1N1); INFLUENZA A VIRUS (H3N2); INFLUENZA B VIRUS; INFLUENZA, HUMAN; MIDDLE AGED; PREGNANCY; PRESCHOOL CHILD; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; INFLUENZA A VIRUS, H1N1 SUBTYPE; INFLUENZA A VIRUS, H3N2 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA, HUMAN; INVESTIGATIONAL NEW DRUG APPLICATION; MALE; MIDDLE AGED; OSELTAMIVIR; PREGNANCY; RETROSPECTIVE STUDIES; UNITED STATES; YOUNG ADULT; ZANAMIVIR;

EID: 84937021481     PISSN: 13596535     EISSN: 20402058     Source Type: Journal    
DOI: 10.3851/IMP2944     Document Type: Review

References (7)

1. Chan-Tack KM, Gao A, Himaya AC, et al. Clinical experience with intravenous zanamivir for influenza treatment under an Emergency IND program in the United States. J Infect Dis 2013; 207:196-198.
2. US Food and Drug Administration. Emergency use of an investigational new drug (IND). Code of federal regulations title 21, part 312.36. (Updated 2009. Accessed 5 February 2015.) Available from http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
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4. Wijaya L, Chua YY, Cui L, et al. Intravenous zanamivir in critically ill patients due to pandemic 2009 H1N1 influenza A virus. Singapore Med J 2011; 52:481-485.
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6. Marty FM, Man CY, van de Horst C, et al. Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, Phase II study. J Infect Dis 2014; 209:542-550.
7. ClinicalTrials.gov. A study of intravenous zanamivir versus oral oseltamivir in adults and adolescents hospitalized with influenza. (Accessed 5 February 2015.) Available from https://clinicaltrials.gov/ct2/show/NCT01231620