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Relenza

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Relenza

Relenza

SIDE EFFECTS

See WARNINGS AND PRECAUTIONS for information about risk of serious adverse events such as bronchospasm and allergic-like reactions, and for safety information in patients with underlying airways disease.

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 aged ≥ 12 years 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)
(n= 1,520)
10 mg b.i.d. Inhaled
(n= 1,132)
All Dosing Regimensa
(n = 2,289)
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 aged 5 to 12 years 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

Adverse Event RELENZA
10 mg b.i.d. Inhaled
(n = 291)
Placebo
(Lactose Vehicle)
(n = 318)
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%
a Includes a subset of patients receiving RELENZA for treatment of influenza in a prophylaxis study.

In 1 of the 2 studies described in Table 2, some additional information is available from children (aged 5 to 12 years) 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 aged ≥ 5 years 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

Adverse Event Contact Cases
RELENZA
(n= 1,068)
Placebo
(n= 1,059)
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%
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.

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 aged ≥ 5 years 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

Adverse Event RELENZA
(n = 2,231)
Placebo
(n = 2,239)
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%
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.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of zanamivir (RELENZA). Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to zanamivir (RELENZA).

Allergic Reactions: Allergic or allergic-like reaction, including oropharyngeal edema [see WARNINGS AND PRECAUTIONS].

Psychiatric: Delirium, including symptoms such as altered level of consciousness, confusion, abnormal behavior, delusions, hallucinations, agitation, anxiety, nightmares [see WARNINGS AND PRECAUTIONS].

Cardiac: Arrhythmias, syncope.

Neurologic: Seizures. Vasovagal-like episodes have been reported shortly following inhalation of zanamivir.

Respiratory: Bronchospasm, dyspnea [see WARNINGS AND PRECAUTIONS].

Skin: Facial edema; rash, including serious cutaneous reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis); urticaria [see WARNINGS AND PRECAUTIONS].

Read the Relenza (zanamivir) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Zanamivir is not a substrate nor does it affect cytochrome P450 (CYP) isoenzymes (CYP1A1/2, 2A6, 2C9, 2C18, 2D6, 2E1, and 3A4) in human liver microsomes. No clinically significant pharmacokinetic drug interactions are predicted based on data from in vitro studies.

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 CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 1/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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