RELENZA (Page 2 of 6)

5.5 Bacterial Infections

Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. RELENZA has not been shown to prevent such complications.

5.6 Importance of Proper Use of DISKHALER

Effective and safe use of RELENZA requires proper use of the DISKHALER to inhale the drug. Prescribers should carefully evaluate the ability of young children to use the delivery system if use of RELENZA is considered [see Use in Specific Populations (8.4)].

6 ADVERSE REACTIONS

See Warnings and Precautions for information about risk of serious adverse events such as bronchospasm (5.1) and allergic-like reactions (5.2), and for safety information in patients with underlying airways disease (5.1).

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 studies consisted of inhaled lactose powder, which is also the vehicle for the active drug; therefore, some adverse events occurring at similar frequencies in different treatment groups could be related to lactose vehicle inhalation.

Treatment of Influenza: Clinical Trials in Adults and Adolescents: Adverse events that occurred with an incidence ≥1.5% in treatment studies are listed in Table 1. This table shows adverse events occurring in patients ≥12 years of age receiving RELENZA 10 mg inhaled twice daily, RELENZA in all inhalation regimens, and placebo inhaled twice daily (where placebo consisted of the same lactose vehicle used in RELENZA).

Table 1. Summary of Adverse Events ≥1.5% Incidence During Treatment in Adults and Adolescents
Adverse Event RELENZA

Placebo

(Lactose Vehicle)

10 mg b.i.d. Inhaled

All Dosing Regimensa

Body as a whole
Headaches 2% 2% 3%
Digestive
Diarrhea 3% 3% 4%
Nausea 3% 3% 3%
Vomiting 1% 1% 2%
Respiratory
Nasal signs and symptoms 2% 3% 3%
Bronchitis 2% 2% 3%
Cough 2% 2% 3%
Sinusitis 3% 2% 2%
Ear, nose, and throat infections 2% 1% 2%
Nervous system
Dizziness 2% 1% <1%
a Includes studies where RELENZA was administered intranasally (6.4 mg 2 to 4 times per day in addition to inhaled preparation) and/or inhaled more frequently (q.i.d.) than the currently recommended dose.

Additional adverse reactions occurring in less than 1.5% of patients receiving RELENZA included malaise, fatigue, fever, abdominal pain, myalgia, arthralgia, and urticaria.

The most frequent laboratory abnormalities in Phase III treatment studies included elevations of liver enzymes and CPK, lymphopenia, and neutropenia. These were reported in similar proportions of zanamivir and lactose vehicle placebo recipients with acute influenza-like illness.

Clinical Trials in Pediatric Patients: Adverse events that occurred with an incidence ≥1.5% in children receiving treatment doses of RELENZA in 2 Phase III studies are listed in Table 2. This table shows adverse events occurring in pediatric patients 5 to 12 years old receiving RELENZA 10 mg inhaled twice daily and placebo inhaled twice daily (where placebo consisted of the same lactose vehicle used in RELENZA).

Table 2. Summary of Adverse Events ≥1.5% Incidence During Treatment in Pediatric Patientsa
a Includes a subset of patients receiving RELENZA for treatment of influenza in a prophylaxis study.
Adverse Event

RELENZA

10 mg b.i.d. Inhaled

Placebo

(Lactose Vehicle)

Respiratory
Ear, nose, and throat infections 5% 5%
Ear, nose, and throat hemorrhage <1% 2%
Asthma <1% 2%
Cough <1% 2%
Digestive
Vomiting 2% 3%
Diarrhea 2% 2%
Nausea <1% 2%

In 1 of the 2 studies described in Table 2, some additional information is available from children (5 to 12 years old) without acute influenza-like illness who received an investigational prophylaxis regimen of RELENZA; 132 children received RELENZA and 145 children received placebo. Among these children, nasal signs and symptoms (zanamivir 20%, placebo 9%), cough (zanamivir 16%, placebo 8%), and throat/tonsil discomfort and pain (zanamivir 11%, placebo 6%) were reported more frequently with RELENZA than placebo. In a subset with chronic pulmonary disease, lower respiratory adverse events (described as asthma, cough, or viral respiratory infections which could include influenza-like symptoms) were reported in 7 of 7 zanamivir recipients and 5 of 12 placebo recipients.

Prophylaxis of Influenza: Family/Household Prophylaxis Studies: Adverse events that occurred with an incidence of ≥1.5% in the 2 prophylaxis studies are listed in Table 3. This table shows adverse events occurring in patients ≥5 years of age receiving RELENZA 10 mg inhaled once daily for 10 days.

Table 3. Summary of Adverse Events ≥1.5% Incidence During 10-Day Prophylaxis Studies in Adults, Adolescents, and Childrena
a In prophylaxis studies, symptoms associated with influenza-like illness were captured as adverse events; subjects were enrolled during a winter respiratory season during which time any symptoms that occurred were captured as adverse events.
Adverse Event Contact Cases

RELENZA

Placebo

Lower respiratory
Viral respiratory infections 13% 19%
Cough 7% 9%
Neurologic
Headaches 13% 14%
Ear, nose, and throat
Nasal signs and symptoms 12% 12%
Throat and tonsil discomfort and pain 8% 9%
Nasal inflammation 1% 2%
Musculoskeletal
Muscle pain 3% 3%
Endocrine and metabolic
Feeding problems (decreased or increased appetite and anorexia) 2% 2%
Gastrointestinal
Nausea and vomiting 1% 2%
Non-site specific
Malaise and fatigue 5% 5%
Temperature regulation disturbances (fever and/or chills) 5% 4%

Community Prophylaxis Studies: Adverse events that occurred with an incidence of ≥1.5% in 2 prophylaxis studies are listed in Table 4. This table shows adverse events occurring in patients ≥5 years of age receiving RELENZA 10 mg inhaled once daily for 28 days.

Table 4. Summary of Adverse Events ≥1.5% Incidence During 28-Day Prophylaxis Studies in Adults, Adolescents, and Childrena
a In prophylaxis studies, symptoms associated with influenza-like illness were captured as adverse events; subjects were enrolled during a winter respiratory season during which time any symptoms that occurred were captured as adverse events.
Adverse Event

RELENZA

Placebo

Neurologic
Headaches 24% 26%
Ear, nose, and throat
Throat and tonsil discomfort and pain 19% 20%
Nasal signs and symptoms 12% 13%
Ear, nose, and throat infections 2% 2%
Lower respiratory
Cough 17% 18%
Viral respiratory infections 3% 4%
Musculoskeletal
Muscle pain 8% 8%
Musculoskeletal pain 6% 6%
Arthralgia and articular rheumatism 2% <1%
Endocrine and metabolic
Feeding problems (decreased or increased appetite and anorexia) 4% 4%
Gastrointestinal
Nausea and vomiting 2% 3%
Diarrhea 2% 2%
Non-site specific
Temperature regulation disturbances (fever and/or chills) 9% 10%
Malaise and fatigue 8% 8%

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