ADVAIR DISKUS ADVAIR - GlaxoSmithKline

Ophthalmologic (Glaucoma and Cataracts)
For patients at risk, monitoring of ocular effects (cataract and glaucoma) should also be
considered in patients receiving maintenance therapy with ADVAIR ® .
Reports of glaucoma have been rare but may be exacerbated by inhaled corticosteroid
treatment. In patients with established glaucoma who require long-term inhaled
corticosteroid treatment, it is prudent to measure intraocular pressure before commencing
the inhaled corticosteroid and to monitor it subsequently. In patients without established
glaucoma, but with a potential for developing intraocular hypertension (e.g. the elderly),
intraocular pressure should be monitored at appropriate intervals.
Reports of cataracts have been uncommon. In elderly patients treated with inhaled
corticosteroids, the prevalence of posterior subcapsular and nuclear cataracts is probably
low but increases in relation to the daily and cumulative lifetime dose. Cofactors such as
smoking, ultraviolet B exposure, or diabetes may increase the risk. Children may be less
susceptible.
Effects of treatment with ADVAIR ® DISKUS ® 50/500 mcg, fluticasone propionate
500 mcg, salmeterol 50 mcg, or placebo on development of cataracts or glaucoma was
evaluated in a subset of 658 patients with COPD in a 3 year (SCO30003) study.
Ophthalmic examinations were conducted at baseline and at 48, 108 and 158 weeks. The
presence of cataracts and glaucoma at baseline was similar across treatment groups (61%
to 71% and 5% to 8%, respectively). New cataracts were diagnosed in all treatment
groups (26% on ADVAIR ® DISKUS ® 50/500 mcg, 17% on fluticasone propionate, 15%
on salmeterol, and 21% on placebo). A few new cases of glaucoma were diagnosed (2%
on ADVAIR ® DISKUS ® 50/500 mcg, 5% on fluticasone propionate, none on salmeterol,
and 2% on placebo). There were no significant differences in the development of
glaucoma or cataracts between any of the treatment groups.
Respiratory
Paradoxical Bronchospasm
As with other inhalation therapy, paradoxical bronchospasm, characterized by an
immediate increase in wheezing after dosing may occur with ADVAIR ® . This should be
treated immediately with a rapid onset, short duration inhaled bronchodilator (e.g.
salbutamol) to relieve acute asthmatic symptoms. ADVAIR ® should be discontinued
immediately, the patient assessed, and if necessary, alternative therapy instituted.
Pneumonia (COPD Patients)
In a 3 year study of 6,184 patients with COPD (SCO30003) there was an increased
reporting of any adverse event of pneumonia in patients receiving ADVAIR ® 50/500 mcg
compared with placebo (16% on ADVAIR ® DISKUS ® 50/500 mcg, 14% on fluticasone
propionate 500 mcg, 11% on salmeterol 50 mcg and 9% on placebo). Physicians should
remain vigilant for the possible development of pneumonia in patients with COPD as the
clinical features of pneumonia and exacerbations frequently overlap (see CLINICAL
TRIAL ADVERSE DRUG REACTIONS, COPD).
July 29, 2014
Page 11 of 67