Relenza
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
RELENZA® (zanamivir) Inhalation Powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than 2 days.
RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older.
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RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see Warnings and Precautions (5.1)].
- RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.
- RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting.
- RELENZA is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee.
- Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA.
- There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B.
- Patients should be advised that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.
History
There is currently no drug history available for this drug.
Other Information
The active component of RELENZA is zanamivir. The chemical name of zanamivir is 5-(acetylamino)-4-[(aminoiminomethyl)-amino]-2,6-anhydro-3,4,5-trideoxy-D-glycero-D-galacto-non-2-enonic acid. It has a molecular formula of C12H20N4O7 and a molecular weight of 332.3. It has the following structural formula:
Zanamivir is a white to off-white powder for oral inhalation with a solubility of approximately 18 mg/mL in water at 20°C.
RELENZA is for administration to the respiratory tract by oral inhalation only. Each RELENZA ROTADISK contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose (which contains milk proteins). The contents of each blister are inhaled using a specially designed breath-activated plastic device for inhaling powder called the DISKHALER. After a RELENZA ROTADISK is loaded into the DISKHALER, a blister that contains medication is pierced and the zanamivir is dispersed into the air stream created when the patient inhales through the mouthpiece. The amount of drug delivered to the respiratory tract will depend on patient factors such as inspiratory flow. Under standardized in vitro testing, RELENZA ROTADISK delivers 4 mg of zanamivir from the DISKHALER device when tested at a pressure drop of 3 kPa (corresponding to a flow rate of about 62 to 65 L/min) for 3 seconds.
Sources
Relenza Manufacturers
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Dispensing Solutions Inc.
![Relenza (Zanamivir) Powder [Dispensing Solutions Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Relenza | Dispensing Solutions Inc.
2.1 Dosing ConsiderationsRELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER device provided.
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 (17.4)]. 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)]. 2.2 Treatment of InfluenzaThe recommended dose of RELENZA for treatment of influenza in adults and pediatric patients 7 years of age and older is 10 mg twice daily (approximately 12 hours apart) for 5 days.
Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses. On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day. The safety and efficacy of repeated treatment courses have not been studied. 2.3 Prophylaxis of InfluenzaHousehold Setting:
The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients 5 years of age and older in a household setting is 10 mg once daily for 10 days. The dose should be administered at approximately the same time each day. There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case.Community Outbreaks:
The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days. The dose should be administered at approximately the same time each day. There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community. The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration. -
Physicians Total Care, Inc.
Relenza | Physicians Total Care, Inc.
2.1 Dosing ConsiderationsRELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER device provided.
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 (17.4)]. 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)]. 2.2 Treatment of InfluenzaThe recommended dose of RELENZA for treatment of influenza in adults and pediatric patients 7 years of age and older is 10 mg twice daily (approximately 12 hours apart) for 5 days.
Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses. On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day. The safety and efficacy of repeated treatment courses have not been studied. 2.3 Prophylaxis of InfluenzaHousehold Setting:
The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients 5 years of age and older in a household setting is 10 mg once daily for 10 days. The dose should be administered at approximately the same time each day. There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case.Community Outbreaks:
The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days. The dose should be administered at approximately the same time each day. There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community. The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration. -
Glaxosmithkline Llc
Relenza | Glaxosmithkline Llc
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 of influenza in adults and pediatric patients aged 7 years and older is 10 mg twice daily (approximately 12 hours apart) for 5 days. • Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses. • On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day. • The safety and efficacy of repeated treatment courses have not been studied. 2.3 Prophylaxis of InfluenzaHousehold Setting:
• The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients aged 5 years and older in a household setting is 10 mg once daily for 10 days. • The dose should be administered at approximately the same time each day. • There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case.Community Outbreaks:
• The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days. • The dose should be administered at approximately the same time each day. • There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community. • The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration.
![Relenza (Zanamivir) Powder [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=315556f2-4da0-47fc-86af-8fb61f6dd3bf&name=4377.jpg)
![Relenza (Zanamivir) Powder [Glaxosmithkline Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d7c3bcc3-0c0d-4068-fd80-88cf54a376ef&name=relenza-spl-graphic-08.jpg)
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