Intravenous Zanamivir in Hospitalized Patients With Influenza

Bradley, John S.; Blumer, Jeffrey L.; Romero, José R.; Michaels, Marian G.; Muñoz, Flor M.; Kimberlin, David W.; Pahud, Barbara; DeBiasi, Roberta L.; Yamamoto, Go; Roberts, G.T.; Hossain, Mohammad; Shortino, Denise; Yates, P.; Adams, Bryan; Peppercorn, Amanda

doi:10.1542/peds.2016-2727

Cited by 33 publications

(33 citation statements)

References 11 publications

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“…Intravenous zanamivir is not approved in the United States and is not available for compassionate use. 25 Intravenous formulations are especially important as the only treatment option for serious influenza infection in those children who cannot absorb orally or enterally administered oseltamivir or tolerate inhaled zanamivir.…”

Section: Antiviral Medications Are Important In the Control Of Influementioning

confidence: 99%

Recommendations for Prevention and Control of Influenza in Children, 2018–2019

2018

Pediatrics

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The authors of this statement update the recommendations of the American Academy of Pediatrics for the routine use of influenza vaccine and antiviral medications in the prevention and treatment of influenza in children. Highlights for the upcoming 2018-2019 season include the following:1. Annual influenza immunization is recommended for everyone 6 months and older, including children and adolescents.2. The American Academy of Pediatrics recommends an inactivated influenza vaccine (IIV), trivalent or quadrivalent, as the primary choice for influenza vaccination in children because the effectiveness of a live attenuated influenza vaccine against influenza A(H1N1) was inferior during past influenza seasons and is unknown for this upcoming season.3. A live attenuated influenza vaccine may be used for children who would not otherwise receive an influenza vaccine (eg, refusal of an IIV) and for whom it is appropriate because of age (2 years of age and older) and health status (ie, healthy and without any underlying chronic medical condition).4. All 2018-2019 seasonal influenza vaccines contain an influenza A(H1N1) vaccine strain similar to that included in the 2017-2018 seasonal vaccines. In contrast, the influenza A(H3N2) and influenza B (Victoria lineage) vaccine strains included in the 2018-2019 trivalent and quadrivalent vaccines differ from those in the 2017-2018 seasonal vaccines.a. Trivalent vaccines contain an influenza A(Michigan/45/2015[H1N1])pdm09-like virus, an influenza A(Singapore/INFIMH-16-0019/2016[H3N2])-like virus (updated), and an influenza B (Colorado/60/2017)-like virus (B/Victoria lineage; updated).b. Quadrivalent vaccines contain an additional B virus (Phuket/3073/2013-like virus; B/Yamagata lineage).5. All children with egg allergy of any severity can receive an influenza vaccine without any additional precautions beyond those recommended for all vaccines.6. Pregnant women may receive an influenza vaccine (IIV only) at any time during pregnancy to protect themselves as well as their infants, who benefit from the transplacental transfer of antibodies. Postpartum women who did not receive vaccination during pregnancy should be encouraged to receive an influenza vaccine before discharge from the hospital. Influenza vaccination during breastfeeding is safe for mothers and their infants.7. The vaccination of health care workers is a crucial step in preventing influenza and reducing health care-associated influenza infections because health care personnel often care for individuals at high risk for influenza-related complications.8. Pediatricians should attempt to promptly identify their patients who are suspected of having an influenza infection for timely initiation of antiviral treatment when indicated and on the basis of shared decision-making between each pediatrician and child caregiver to reduce morbidity and mortality. Although best results are seen when a child is treated within 48 hours of symptom onset, antiviral therapy should still be considered beyond 48 hours of symptom onset in childre...

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Section: Antiviral Medications Are Important In the Control Of Influementioning

confidence: 99%

Recommendations for Prevention and Control of Influenza in Children, 2018–2019

2018

Pediatrics

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“…36 Of note, an intravenous formulation of zanamivir was recently compared with oral oseltamivir in adults and adolescents hospitalized with influenza in a Phase III clinical trial. 14,43 In the study, zanamivir was not found to be superior to oseltamivir in a hospitalized population. The other intravenous neuraminidase inhibitor, peramivir, is only approved for the treatment of uncomplicated influenza in children aged 2 years and in adults.…”

Section: Fda-approved Therapiesmentioning

confidence: 81%

A Review of Therapeutics in Clinical Development for Respiratory Syncytial Virus and Influenza in Children

Nicholson

Muñoz

2018

Clinical Therapeutics

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“…zanamivir showed similar PK, safety, and efficacy results in children compared with adults. 21 As zanamivir is predominantly cleared renally as unchanged drug, impaired renal function is expected to affect zanamivir's clearance. PopPK indicated that its halflife increases two to threefold for severe and end-stage renal disease.…”

Section: %Change From Baseline Of Viral Load (Qrt-pcr)mentioning

confidence: 99%

Population Pharmacokinetic/Pharmacodynamic Analysis of Intravenous Zanamivir in Healthy Adults and Hospitalized Adult and Pediatric Subjects With Influenza

Zuo

Collins

Okour

et al. 2019

Clinical Translational Sci

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Zanamivir is a potent and highly selective inhibitor of influenza neuraminidase in which the inhibition of this enzyme prevents the virus from infecting other cells and specifically prevents release of the new virion from the host cell membrane. It is available as an oral powder for inhalation and intravenous formulations. The current population pharmacokinetic model based on data from eight studies of subjects treated with the intravenous formulation (125 healthy adults and 533 hospitalized adult and pediatric subjects with suspected or confirmed influenza) suggested a decreased zanamivir clearance in pediatric and renal impairment adult subjects. It also indicates that b.i.d. dosing is necessary to keep the exposure in influenza infected subjects above the 90% inhibitory concentration values of recently circulating viruses over the dosing interval. In the exposure‐response analysis (phases II and III studies), no apparent relationship was found between zanamivir exposure and clinically relevant pharmacodynamic end points.

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Intravenous Zanamivir in Hospitalized Patients With Influenza

Abstract: The safety profile of IV zanamivir was favorable, with no drug-related STEAEs reported. The majority of children experienced virologic response and clinical improvement during the treatment course. Systemic zanamivir exposures in children were consistent with adults.

Cited by 33 publications

References 11 publications

Recommendations for Prevention and Control of Influenza in Children, 2018–2019

Recommendations for Prevention and Control of Influenza in Children, 2018–2019

A Review of Therapeutics in Clinical Development for Respiratory Syncytial Virus and Influenza in Children

Population Pharmacokinetic/Pharmacodynamic Analysis of Intravenous Zanamivir in Healthy Adults and Hospitalized Adult and Pediatric Subjects With Influenza

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