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Relenza (Zanamivir) - Summary

 
 



RELENZA SUMMARY

The active component of RELENZA is zanamivir, an antiviral agent.

RELENZA is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years and older who have been symptomatic for no more than 2 days (see Description of Clinical Studies and PRECAUTIONS).

RELENZA is not recommended for treatment of patients with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) (see WARNINGS and PRECAUTIONS).
See all Relenza indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Relenza (Zanamivir)

Medical News Today: Flu Symptoms (Influenza Symptoms): Signs, Duration, Complications
Source: Featured Health News from Medical News Today [2016.02.05]
Find out all about the signs and symptoms of influenza, the seasonal respiratory illness that is commonly referred to as flu. Flu is most common between December and February.

Flu Symptoms (Influenza Symptoms): Signs, Duration, Complications
Source: Body Aches News From Medical News Today [2016.02.05]
Find out all about the signs and symptoms of influenza, the seasonal respiratory illness that is commonly referred to as flu. Flu is most common between December and February.

Fighting flu with designer drugs: a new compound given before or after exposure fends off different influenza strains
Source: Flu / Cold / SARS News From Medical News Today [2016.02.04]
A study published in PLOS Pathogens reports that a new antiviral drug protects mice against a range of influenza virus strains.

Flu vaccine shows promise for reducing risk of influenza-associated atrial fibrillation
Source: Cardiovascular / Cardiology News From Medical News Today [2016.02.02]
Influenza is significantly associated with an increased risk of new-onset atrial fibrillation, which could be reduced through influenza vaccination, according to new findings reported HeartRhythm.

CDC Alert: Severe Influenza Illness Reported
Source: Medscape Allergy & Clinical Immunology Headlines [2016.02.01]
Clinicians should initiate antiviral treatment to very ill and high-risk patients suspected of having influenza without waiting for test results. ICU admissions and deaths have been reported.
Medscape Medical News

more news >>

Published Studies Related to Relenza (Zanamivir)

Efficacy of oseltamivir-zanamivir combination compared to each monotherapy for seasonal influenza: a randomized placebo-controlled trial. [2010.11.02]
CONCLUSIONS: In adults with seasonal influenza A mainly H3N2 virus infection, the oseltamivir-zanamivir combination appeared less effective than oseltamivir monotherapy, and not significantly more effective than zanamivir monotherapy. Despite the theoretical potential for the reduction of the emergence of antiviral resistance, the lower effectiveness of this combination calls for caution in its use in clinical practice. TRIAL REGISTRATION: www.ClinicalTrials.govNCT00799760.

A comparison of the effectiveness of zanamivir and oseltamivir for the treatment of influenza A and B. [2008.01]
OBJECTIVE: To compare the effectiveness of zanamivir with oseltamivir for influenza A and B... CONCLUSION: Zanamivir therapy is more effective than oseltamivir for the treatment of influenza B infection.

Efficacy and Safety of Inhaled Zanamivir in the Prevention of Influenza in Community-Dwelling, High-Risk Adult and Adolescent Subjects: A 28-day, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. [2007.08]
Background: Influenza can cause significant morbidity and mortality in subjects at high risk for complications, including the elderly (age >/=65 years) and those with chronic respiratory, cardiovascular, or metabolic conditions...

Safety and efficacy of nebulized zanamivir in hospitalized patients with serious influenza. [2003.06]
Influenza is an important cause of hospitalization due to lower respiratory tract involvement for which there is no specific antiviral treatment with proven efficacy. We conducted a double-blind, randomized, placebo-controlled trial to assess the tolerability and efficacy of nebulized zanamivir (16 mg four times a day) in combination with rimantadine compared to rimantadine with nebulized saline for treating influenza in adults hospitalized with influenza...

Zanamivir: a significant reduction in viral load during treatment in military conscripts with influenza. [2003]
A randomized, double-blind, placebo-controlled, parallel-group trial performed at 5 residential units of the Finnish Defence Forces was conducted to assess the antiviral activity, efficacy and safety of inhaled zanamivir for the treatment of naturally acquired influenza... Zanamivir rapidly reduced viral load following the start of therapy compared with placebo and was well tolerated.

more studies >>

Clinical Trials Related to Relenza (Zanamivir)

Prophylactic Efficacy of Relenza Against Influenza A and B [Completed]
In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS 1. Determine the frequency of patients who received Relenza from October 2006 through April 2009, and among them the number who have no concurrent diagnosis of influenza, i. e., those receiving Relenza for prophylaxis, and among these the number who have a family member with a medical visit for influenza within three days preceding the above indentified patient's dispensing of Relenza. This is to determine the feasibility of conducting detailed analysis. 2. If analysis is feasible then tabulate the frequency of influenza-like-illness and respiratory outcomes in users of prophylactic Relenza and their family members and in family members of persons using Relenza for the treatment of influenza (i. e., index cases). 3. If analysis is feasible then estimate the direct effect of prophylactic Relenza on the occurrence of influenza-like-illness and respiratory outcomes, the secondary effect of Relenza treatment of influenza on susceptible family members, and the total effect of Relenza (treatment plus prophylaxis). METHODS Overview of Study Design This is an analysis of the 30-day risk of influenza-like illness and respiratory outcomes in persons for whom some household members (index cases) have had a medical visit associated with a diagnosis of influenza. The exposed individuals to the index case will be categorized into one of four cohorts according to whether the exposed person received prophylactic Relenza or no antiviral treatment and by whether the index family member with a diagnosis of influenza received antiviral treatment. Estimates of the direct effect of Relenza prophylaxis, the indirect effectof preventing disease in susceptible family members, and the total effect of disease reduction when both index cases and susceptible family members are treated will be obtained from different comparisons between cohorts, as outlined below. The research will cover the first three influenza seasons during which Relenza has been indicated for prophylactic use in the United States. These will be from October through April of 2006-2009.

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects [Withdrawn]
This study is a 4 period study to see if there is any interaction between Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Thai Adult Subjects

Pharmacokinetics of Zanamivir After Single and Repeated Dose Infusion Administration in Healthy Chinese Adults [Completed]
Zanamivir is a potent and highly selective inhibitor of the influenza virus neuraminidase. Intravenous (IV) zanamivir is being developed for treatment of hospitalized patients with influenza, especially for those patients who may be in greatest need of parenteral influenza antiviral agents. This study is a pharmacokinetic (PK) study to evaluate the safety/tolerability and pharmacokinetic profiles of IV zanamivir 300 milligrams (mg) and 600 mg in Chinese healthy subjects. Subjects will be randomized to receive either 300 mg or 600 mg IV zanamivir as a single dose followed by repeated dose every 12 hours (h) for 5 days. Subjects will be contacted or will return to study center for a follow-up visit, 7 days after the last dose or withdrawal from the study. Total number of subjects planned for enrollment will be 24 such that approximately 10 subjects complete dosing and critical assessments in each dose cohort. The total duration of the study will be approximately 6 weeks from screening to follow-up.

RelenzaŽ Sentinel Site Monitoring Program in Japan [Completed]
To collect background information of patients receiving a prescription for RelenzaŽ and study risk factors etc. for adverse drug reactions collected through spontaneous reporting. In particular, to characterize the types and incidences of adverse events, serious adverse events, and adverse drug reactions and to investigate risk factors for them in patient populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the use experience of RelenzaŽ has not been enough (such as pregnant women, infants, elderly persons, and those with decreased physical function) in accordance with the PFSB/SD Notification 0904, No. 2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW, dated 4th September 2009. To compare the data with the safety data collected in overseas sentinel site monitoring programs.

A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers [Completed]
Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each dosing period and will remain in the unit until Day 2. Each subject will receive a single dose of each of the four treatments on Day 1 of each treatment period in a randomized fashion. Subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 of each period and return approximately 5-7 days later for the next dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following each treatment.

more trials >>

Reports of Suspected Relenza (Zanamivir) Side Effects

Abnormal Behaviour (40)Hallucination (17)Delirium (17)Aggression (12)Screaming (10)Loss of Consciousness (8)Nausea (8)Convulsion (8)Depressed Level of Consciousness (8)Pyrexia (7)more >>


Page last updated: 2016-02-05

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