RELENZA

RELENZA — zanamivir powder
Dispensing Solutions Inc.

1 INDICATIONS AND USAGE

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 7 years of age 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 5 years of age and older.

1.3 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 (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.

2 DOSAGE AND ADMINISTRATION

2.1 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 (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 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.

2.3 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.

3 DOSAGE FORMS AND STRENGTHS

Blister for oral inhalation: 5 mg. 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 (16)].

4 CONTRAINDICATIONS

Do not use in patients with history of allergic reaction to any ingredient of RELENZA including lactose (which contains milk proteins) [see Warnings and Precautions (5.2), Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Bronchospasm

RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease).

Serious cases of bronchospasm, including fatalities, have been reported during treatment with RELENZA in patients with and without underlying airways disease. Many of these cases were reported during postmarketing and causality was difficult to assess.

RELENZA should be discontinued in any patient who develops bronchospasm or decline in respiratory function; immediate treatment and hospitalization may be required.

Some patients without prior pulmonary disease may also have respiratory abnormalities from acute respiratory infection that could resemble adverse drug reactions or increase patient vulnerability to adverse drug reactions.

Bronchospasm was documented following administration of zanamivir in 1 of 13 patients with mild or moderate asthma (but without acute influenza-like illness) in a Phase I study. In a Phase III study in patients with acute influenza-like illness superimposed on underlying asthma or chronic obstructive pulmonary disease, 10% (24 of 244) of patients on zanamivir and 9% (22 of 237) on placebo experienced a greater than 20% decline in FEV1 following treatment for 5 days.

If use of RELENZA is considered for a patient with underlying airways disease, the potential risks and benefits should be carefully weighed. If a decision is made to prescribe RELENZA for such a patient, this should be done only under conditions of careful monitoring of respiratory function, close observation, and appropriate supportive care including availability of fast-acting bronchodilators.

5.2 Allergic Reactions

Allergic-like reactions, including oropharyngeal edema, serious skin rashes, and anaphylaxis have been reported in postmarketing experience with RELENZA. RELENZA should be stopped and appropriate treatment instituted if an allergic reaction occurs or is suspected.

5.3 Neuropsychiatric Events

Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.

There have been postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including RELENZA. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon based on usage data for RELENZA. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of RELENZA to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.

5.4 Limitations of Populations Studied

Safety and efficacy have not been demonstrated in patients with high-risk underlying medical conditions. No information is available regarding treatment of influenza in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring inpatient management.

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