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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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Relenza (Zanamivir)

Groups At High Risk Of H1N1 Influenza A Should Avoid Travelling To 2009 HAJJ
Source: Respiratory / Asthma News From Medical News Today [2009.11.19]
Some 2.5 million pilgrims are expected at holy sites in Saudi Arabia for the 2009 Hajj, expected to begin around November 25. To combat the threat posed by H1N1 influenza A, the Saudi Arabian Health Ministry has issued public health recommendations, including recommending groups at highest risk of contracting H1N1 postpone their pilgrimage to a later year when the threat is reduced.

School-based H1N1 Influenza Clinics To Begin For K-3 Students, Alabama
Source: Flu / Cold / SARS News From Medical News Today [2009.11.19]
The Alabama Department of Public Health will begin offering nasal mist flu vaccine to kindergarten through third grade students in Alabama schools at voluntary H1N1 influenza vaccination clinics. A few clinics will begin the week of Nov. 23, but the majority will be held beginning the week of Nov. 30-Dec. 5. "Vaccination is the best way to protect your children from this potentially serious disease," said State Health Officer Dr. Donald Williamson.

FDA Grants Emergency Use Authorization To Roche´s Assay For 2009 H1N1 Influenza Virus
Source: Flu / Cold / SARS News From Medical News Today [2009.11.18]
Roche`s (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY)

Study Shows Link Between Influenza Virus And Fever
Source: Biology / Biochemistry News From Medical News Today [2009.11.17]
Viruses are microscopically sized parasites. They plant their genes in the cells of their victim in order to 'reprogram' them. The infected cells then no longer produce what they need to live, making lots of new viruses instead. Luckily, in most cases this hostile takeover does not go unnoticed. This is ensured by the cells' own sensors that recognise alien genetic material. One of them is RIG-I. When RIG-I encounters virus genes, it ensures that the body releases interferon.

FDA Approves Additional Vaccine For 2009 H1N1 Influenza Virus
Source: Flu / Cold / SARS News From Medical News Today [2009.11.17]
The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC. As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.

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Published Studies Related to Relenza (Zanamivir)

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.

Zanamivir prophylaxis: an effective strategy for the prevention of influenza types A and B within households. [2002.12.01]
A double-blind, randomized study of inhaled zanamivir for the prevention of influenza in families was conducted. Once a person with a suspected case of influenza was identified (index patient), treatment of all other household members (contacts) > or =5 years old was initiated.Zanamivir was well tolerated and was effective in preventing influenza types A and B within households where the index patient was not treated.

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Clinical Trials Related to Relenza (Zanamivir)

Evaluation of Efficacity and Safety of Oseltamivir and Zanamivir [Not yet recruiting]
In order to prevent the high mortality due to an hypothetic pandemic caused by a newly emerging influenza A virus, antiviral drugs are seen as essential requirements for control of initial influenza outbreaks. Two antivirals are available for the treatment oseltamivir and zanamivir. Emergence of Oseltamivir resistance has been recently reported. . It appeared opportune to assess the efficacy and safety of biotherapy of neuraminidase inhibitors ,will be investigated by a randomized, placebo controlled, double blind study in France, during the next winter season . This study will be conducted in 300 centres of primary care with 900 adults with a virologically suspected influenza A infection. Individuals will be randomized to 1 of the 3 treatment groups: oseltamivir +zanamivir, or oseltamivir+placebo or placebo +zanamivir. The primary judgment criteria will be the proportion of patients with negative RT PCR negative in nasal secretions at Day 2.

A Study to Evaluate Orally-Administered Oseltamivir and Intravenous Zanamivir in Healthy Subjects [Terminated]
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

Pharmacokinetic Study of Oseltamivir and Intravenous Zanamivir in Healthy Adults [Recruiting]
Due in part to widespread availability of oseltamivir and clinical experience using oseltamivir to treat H5N1 influenza virus infections, many strains of influenza have become resistant to it. Other reliable methods of treating H5N1 must be identified in case of a pandemic. One such option is intravenous zanamivir used in combination with oseltamivir. The primary purpose of this study is to evaluate the interaction between oral oseltamivir and intravenous zanamivir administered as either a continuous or intermittent infusion in healthy adults.

Zanamivir Versus Trivalent Split Virus Influenza Vaccine [Not yet recruiting]
This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers.

The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.

Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Repeat Dose Zanamivir/Placebo Via Devices Administered Twice Daily for 5 Days [Not yet recruiting]
The purpose of this study is to compare the safety and tolerability of Zanamivir using a Rotahaler device presentation to placebo within the Rotahaler presentation and to the Diskhaler device.

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Page last updated: 2009-11-19

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