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Relenza (Zanamivir) - Indications and Dosage

Relenza Rx
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INDICATIONS AND USAGE

Treatment of Influenza

RELENZA 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 .

Prophylaxis of Influenza

RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older.

Important Limitations on Use of RELENZA

  • 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].

  • 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.

DOSAGE AND ADMINISTRATION

Dosing Considerations

  • RELENZA 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].
  • Patients scheduled to use an inhaled bronchodilator at the same time as RELENZA should use their bronchodilator before taking RELENZA [see Patient Counseling Information].

Treatment of Influenza

  • The 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.

Prophylaxis of Influenza

Household 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.

DOSAGE FORMS AND STRENGTHS

Four 5 mg blisters of powder on a ROTADISK for oral inhalation via DISKHALER. Packaged in carton containing 5 ROTADISKs (total of 10 doses) and 1 DISKHALER inhalation device [see How Supplied/Storage and Handling].

HOW SUPPLIED/STORAGE AND HANDLING

RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device (NDC 0173-0681-01).

Store at 25 ° C (77 ° F); excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F) (see USP Controlled Room Temperature). Keep out of reach of children. Do not puncture any RELENZA ROTADISK blister until taking a dose using the DISKHALER.

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