A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Relenza Side Effects, and Drug Interactions - Zanamivir
Relenza Side Effects, and Drug Interactions - Zanamivir
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
respiratory disease.
Clinical Trials in Adults and Adolescents: Adverse events
that occurred with an incidence ³1.5% in treatment
studies are listed in Table 1. This table shows adverse events occurring in
patients ³12 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 ³1.5%
Incidence During Treatment in Adults and Adolescents
|
|
Adverse Event
|
RELENZA 10 mg b.i.d. Inhaled
|
All Dosing Regimens*
|
Placebo(Lactose Vehicle†)
|
| |
(n = 1,132)
|
(n = 2,289)
|
(n = 1,520)
|
|
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, & throat infections
|
2%
|
1%
|
2%
|
|
Nervous system
|
|
Dizziness
|
2%
|
1%
|
<1%
|
|
* 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.
|
|
† Because the placebo consisted of inhaled
lactose powder, which is also the vehicle for the active drug, some adverse
events occurring at similar frequencies in different treatment groups
could be related to lactose vehicle inhalation.
|
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 3 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 ³1.5% in children
receiving treatment doses of RELENZA in 2 Phase 3 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 ³1.5%
Incidence During Treatment in Pediatric Patients*
|
|
Adverse Event
|
RELENZA10 mg b.i.d. Inhaled
|
Placebo(Lactose Vehicle†)
|
|
(n = 291)
|
(n = 318)
|
|
Respiratory
|
|
Ear, nose, & throat infections
|
5%
|
5%
|
|
Ear, nose, & throat hemorrhage
|
<1%
|
2%
|
|
Asthma
|
<1%
|
2%
|
|
Cough
|
<1%
|
2%
|
|
Digestive
|
|
Vomiting
|
2%
|
3%
|
|
Diarrhea
|
2%
|
2%
|
|
Nausea
|
<1%
|
2%
|
|
* Includes a subset of patients receiving RELENZA for
treatment of influenza in a prophylaxis study.
|
|
† Because the placebo consisted of inhaled
lactose powder, which is also the vehicle for the active drug, some adverse
events occurring at similar frequencies in different treatment groups
could be related to lactose vehicle inhalation.
|
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
respiratory 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.
Observed During Clinical Practice: In addition to adverse
events reported from clinical trials, the following events have been identified
during post-marketing 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).
General: Allergic or allergic-like reaction,
including oropharyngeal edema (see PRECAUTIONS).
Cardiac: Arrhythmias, syncope.
Neurologic: Seizures.
Respiratory: Bronchospasm, dyspnea (see WARNINGS
and PRECAUTIONS).
Skin: Facial edema; rash, including serious cutaneous
reactions (see PRECAUTIONS).
DRUG INTERACTIONS
No clinically significant pharmacokinetic drug interactions
are predicted based on data from in vitro studies.
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