RELENZA 5 mg/1
zanamivir · POWDER · GlaxoSmithKline LLC
Relenza is a prescription antiviral medication that is inhaled into the lungs to treat or prevent influenza (flu) infection. It works by blocking a viral enzyme that allows the flu virus to spread in your body.
Key Facts
- Brand Name
- RELENZA
- Generic Name
- zanamivir
- NDC Code (Product)
0173-0681- Manufacturer
- GlaxoSmithKline LLC
- Strength
- 5 mg/1
- Dosage Form
- POWDER
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA021036
- Drug Class
- Neuraminidase Inhibitor [EPC]
- Marketing Start
- 09/22/1999
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. ( 1.1 ) Prophylaxis of influenza in patients aged 5 years and older. ( 1.2 ) Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in: • Individuals with underlying airways disease. ( 5.1 ) Not proven effective for: • Treatment in individuals with underlying airways disease. ( 1.3 ) • Prophylaxis in nursing home residents. ( 1.3 ) Not a substitute for annual influenza vaccination. ( 1.3 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA. ( 1.3 ) 1.1 Treatment of Influenza RELENZA (zanamivir) inhalation powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7 years and older who have been symptomatic for no more than 2 days. 1.2 Prophylaxis of Influenza RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Dose Treatment of Influenza ( 2.2 ) 10 mg twice daily for 5 days Prophylaxis: ( 2.3 ) Household Setting 10 mg once daily for 10 days Community Outbreaks 10 mg once daily for 28 days Note: The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation). ( 2.1 ) 2.1 Dosing Considerations • RELENZA is for administration to the respiratory tract by oral inhalation only , using the DISKHALER device provided [see Warnings and Precautions ( 5.6 )] . • The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation). • Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible. If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see Patient Counseling Information ( 17 )] . • Patients scheduled to use an inhaled bronchodilator at the same time as RELENZA should use their bronchodilator before taking RELENZA [see Patient Counseling Information ( 17 )] . 2.2 Treatment of Influenza • The recommended dose of RELENZA for treatment o…
Contraindications
4 CONTRAINDICATIONS RELENZA is contraindicated in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins [see Warnings and Precautions ( 5.2 ), Description ( 11 )] . Do not use in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The concurrent use of RELENZA with live attenuated influenza vaccine (LAIV) intranasal has not been evaluated. However, because of potential interference between these products, LAIV should not be administered within 2 weeks before or 48 hours after administration of RELENZA, unless medically indicated. The concern about possible interference arises from the potential for antiviral drugs to inhibit replication of live vaccine virus. Trivalent inactivated influenza vaccine can be administered at any time relative to use of RELENZA [see Microbiology ( 12.4 )] . Live attenuated influenza vaccine, intranasal ( 7 ): • Do not administer until 48 hours following cessation of RELENZA. • Do not administer RELENZA until 2 weeks following administration of the live attenuated influenza vaccine, unless medically indicated.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Bronchospasm [see Warnings and Precautions ( 5.1 )] . • Safety information in patients with underlying airways disease [see Warnings and Precautions ( 5.1 )]. • Allergic-like reactions [see Warnings and Precautions ( 5.2 )] . The most common adverse events reported in greater than 1.5% of subjects treated with RELENZA and more commonly than in subjects treated with placebo are: • Treatment Trials – sinusitis, dizziness. ( 6.1 ) • Prophylaxis Trials – fever and/or chills, arthralgia, and articular rheumatism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The placebo used in clinical trials consisted of inhaled lactose powder, which is also the vehicle for the active drug; therefor…
Frequently Asked Questions
What is RELENZA used for?
Relenza is a prescription antiviral medication that is inhaled into the lungs to treat or prevent influenza (flu) infection. It works by blocking a viral enzyme that allows the flu virus to spread in your body.
Is RELENZA a controlled substance?
RELENZA is not classified as a controlled substance by the DEA.
What is the generic name for RELENZA?
The generic name for RELENZA is zanamivir. There are no other listed brand versions of zanamivir.
What is the NDC code for RELENZA 5 mg/1?
The NDC (National Drug Code) for RELENZA 5 mg/1 is 0173-0681, listed by GlaxoSmithKline LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)