Indications for: FLOVENT HFA
Maintenance treatment of asthma as prophylactic therapy.
Limitations of Use:
Not for the relief of acute bronchospasm.
Adult and Adolescent Patients Aged 12 Years and Older
The efficacy and safety of Flovent HFA was assessed in 3 randomized, double-blind, parallel-group, placebo-controlled, US clinical trials in 980 adult and adolescent patients 12 years of age and older with asthma.
Fixed doses of 88, 220, and 440 mcg twice daily and 880 mcg twice daily were compared with placebo.
Patients included those inadequately controlled with bronchodilators alone (Trial 1), those already receiving daily ICS (Trial 2), and those requiring oral corticosteroid therapy (Trial 3). In all 3 trials, patients were allowed to use Ventolin Inhalation Aerosol as needed for relief of acute asthma symptoms. In Trials 1 and 2, other maintenance asthma therapies were discontinued.
In Trial 1: Results showed that all 3 dosages (88, 220, and 440 mcg twice daily) of Flovent HFA achieved a statistically significant improvement in lung function, as measured by improvement in AM pre-dose FEV1, compared with placebo. This improvement was seen after the first week then maintained over the 12-week period.
In Trial 2: Results showed that all 3 dosages (88, 220, and 440 mcg twice daily) of Flovent HFA achieved a statistically significant improvement in lung function, as measured by improvement in FEV1, compared with placebo. This improvement was seen after the first week then maintained over the 12-week period.
In Trial 3: Results showed that patients treated with either 440 or 880 mcg twice daily of Flovent HFA required a statistically significantly lower mean daily oral prednisone dose (6 mg) compared with placebo-treated patients (15 mg). Additionally, patients in the Flovent HFA arm achieved statistically significantly improved lung function, fewer asthma symptoms, and less use of Ventolin Inhalation Aerosol compared with those in the placebo arm.
Two long-term safety trials (Trial 4 and Trial 5):
Trial 4 evaluated the safety of 2 doses of Flovent HFA, while Trial 5 compared fluticasone propionate HFA with fluticasone propionate CFC. Each trial was at least 6 months’ duration and included adult and adolescent subjects with asthma.
Trial 4 enrolled 182 subjects who were treated daily with low to high doses of ICS, beta-agonists (short-acting [as needed or regularly scheduled] or long-acting), theophylline, inhaled cromolyn or nedocromil sodium, leukotriene receptor antagonists, or 5-lipoxygenase inhibitors at baseline. Flovent HFA at dosages of 220 and 440 mcg twice daily was evaluated over a 26-week treatment period in 89 and 93 subjects, respectively.
Trial 5 enrolled 325 subjects who were treated daily with moderate to high doses of ICS, with or without concurrent use of salmeterol or albuterol, at baseline. Fluticasone propionate HFA at a dosage of 440 mcg twice daily and fluticasone propionate CFC at a dosage of 440 mcg twice daily were evaluated over a 52-week treatment period in 163 and 162 subjects, respectively.
Both formulations of fluticasone propionate maintained asthma control throughout the 52-week treatment period compared with baseline. In both trials, none of the subjects were withdrawn due to lack of efficacy.
Pediatric Subjects Aged 4 to 11 Years
A 12-week clinical trial was conducted in 241 pediatric patients with asthma. Findings were supportive of efficacy but inconclusive due to measurable levels of fluticasone propionate in 6/48 (13%) of the plasma samples.
Previously on bronchodilators alone: initially 88mcg twice daily (approx. 12hrs apart); max 880mcg twice daily. Rinse mouth after use. Titrate to lowest effective dose after stability achieved. Re-evaluate if inadequate control.
<4yrs: not established. 4–11yrs: 88mcg twice daily (approx. 12hrs apart). Rinse mouth after use. Titrate to lowest effective dose after stability achieved. Re-evaluate if inadequate control.
FLOVENT HFA Contraindications:
Primary treatment of status asthmaticus or other acute attacks requiring intensive measures.
FLOVENT HFA Warnings/Precautions:
Maintain regular regimen. Immunosuppression. Tuberculosis. Systemic infections (eg, fungal, bacterial, viral, parasitic). Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, IOP, glaucoma, or cataracts. Consider eye exams if ocular symptoms develop or in long-term use. Discontinue and treat if paradoxical bronchospasm occurs; use alternative therapy. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, tobacco use, advanced age, poor nutrition, others). Eosinophilic conditions. Hepatic impairment; monitor. Transferring from oral corticosteroids: see full labeling. Pregnancy. Nursing mothers.
FLOVENT HFA Classification:
FLOVENT HFA Interactions:
Concomitant strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, ketoconazole, nefazodone, others): not recommended.
Upper respiratory tract infection/inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, headache; immunosuppression, adrenal suppression, bronchospasm, hypersensitivity reactions.
Following IV dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of ~7.8 hours.
The total clearance of fluticasone propionate is high (average, 1,093 mL/min), with renal clearance accounting for <0.02% of the total.
Less than 5% of a radiolabeled oral dose was excreted in the urine as metabolites, with the remainder excreted in the feces as parent drug and metabolites.
Generic Drug Availability:
Inhaler w. actuator (44mcg)—10.6g (120 inh); 110mcg, 220mcg—12g (120 inh)