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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.1 ) • Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.3 ) • Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Fluticasone Furoate ELLIPTA. ( 5.4 ) • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone Furoate ELLIPTA slowly. ( 5.5 ) • If paradoxical bronchospasm occurs, discontinue Fluticasone Furoate ELLIPTA and institute alternative therapy. ( 5.7 ) • Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.9 ) • Monitor growth of pediatric patients. ( 5.10 ) • Glaucoma and cataracts may occur with long-term use of inhaled corticosteroids. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Fluticasone Furoate ELLIPTA long term. ( 5.11 ) 5.1 Oropharyngeal Candidiasis Fluticasone Furoate ELLIPTA contains fluticasone furoate, an ICS. Localized infections of the mouth and pharynx with Candida albicans have occurred in subjects treated with orally inhaled drug products containing fluticasone furoate. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Fluticasone Furoate ELLIPTA continues. In some cases, therapy with Fluticasone Furoate ELLIPTA may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following administration of Fluticasone Furoate ELLIPTA to help reduce the risk of oropharyngeal candidiasis. 5.2 Acute Asthma Episodes Fluticasone Furoate ELLIPTA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for treatm...
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adverse reactions
6 ADVERSE REACTIONS Systemic and local corticosteroid use may result in the following: • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] • Reduction in BMD [see Warnings and Precautions ( 5.9 )] • Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. ( 6.1 ) Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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. Adult and Pediatric Subjects Aged 12 Years and Older The safety of fluticasone furoate ELLIPTA was evaluated in 10 double-blind, parallel-group, controlled trials (7 with placebo) of 8 to 76 weeks’ duration that enrolled 6,219 subjects with asthma. Doses of fluticasone furoate studied ranged from 25 to 800 mcg. Fluticasone furoate ELLIPTA 100 mcg was studied in 1,663 subjects, and fluticasone furoate ELLIPTA 200 mcg was studied in 608 subjects. Subject ages ranged from 12 to 84 years, 65% were female, and 75% were Caucasian. In these trials, the proportion of subjects who discontinued study treatment early due to adverse reactions was 2% for subjects treated with both fluticasone furoate ELLIPTA 100 mcg and fluticasone furoate ELLIPTA 200 mcg and ≤1% for placebo-treated subjects. Serious adverse events, whether considered drug-related or not by the investigators, that occurred in more than 1 subject and in a greater percentage of subjects treated with fluticasone furoate ELLIPTA than placebo included hypertension, abscess, breast cancer, traumatic limb amputation, subarachnoid hemorrhage, and interve...
adverse reactions table
Table 1. Adverse Reactions with Fluticasone Furoate ELLIPTA 100 mcg with ≥3% Incidence and More Common than Placebo (Trial 1, Intent-to-Treat Population)Adverse ReactionFluticasone Furoate ELLIPTA 100 mcg(n = 114)%Placebo(n = 115)%Nasopharyngitis85Bronchitis76Upper respiratory tract infection65Headache64Pharyngitis43Sinusitis4<1Toothache3<1Gastroenteritis viral30Oral candidiasis30Oropharyngeal candidiasis30Oropharyngeal pain30