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BREO ELLIPTA is a brand name for Vilanterol, supplied as a powder. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................ 3 CONTRAINDICATIONS ................................................................................................ 4 WARNINGS AND PRECAUTIONS................................................................................ 5…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations COPD and Asthma As with other inhaled drugs containing beta2-adrenergic agents, BREO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result.
d) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute respiratory symptoms while taking BREO ELLIPTA. It is crucial to inform patients that BREO ELLIPTA should not be used to treat acute symptoms of asthma or COPD.
, salbutamol) to relieve the acute symptoms such as shortness of breath and advised to have this available for use at all times. Patients should be made aware that for optimum benefit, BREO ELLIPTA must be used regularly, even when asymptomatic.
If a previously effective dose of BREO ELLIPTA fails to provide adequate control of asthma symptoms, patients should seek medical advice as this indicates worsening of their underlying condition. Asthma When treating patients with asthma, physicians should only prescribe BREO ELLIPTA for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants treatment with both an inhaled corticosteroid and LABA.
Patients with asthma should be regularly re-assessed by a healthcare professional so that the dose of BREO ELLIPTA they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Page 27 of 74 Recommended Dose and Dosage Adjustment The recommended dose of BREO ELLIPTA in adults 18 years of age and older is: COPD Asthma BREO ELLIPTA 100/25 mcg One inhalation once daily One inhalation once daily BREO ELLIPTA 200/25 mcg Not indicated One inhalation once daily COPD The recommended dose is one inhalation of BREO ELLIPTA 100/25 mcg once daily.
The maximum recommended dose is one inhalation of BREO ELLIPTA 100/25 mcg once daily. BREO ELLIPTA 200/25 mcg is not indicated for the treatment of COPD. Asthma The recommended dose is one inhalation of BREO ELLIPTA 100/25 mcg or 200/25 mcg once-daily.
The maximum recommended dose is one inhalation of BREO ELLIPTA 200/25 mcg once daily. The starting dose is based on patients’ asthma severity. For patients previously treated with low- to mid-dose corticosteroid-containing treatment, BREO ELLIPTA 100/25 mcg should be considered.
General Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death (see Salmeterol Multicenter Asthma Research Trial (SMART)).
Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy.
When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone (see Serious Asthma- Related Events with Inhaled Corticosteroid/Long-acting Beta2-adrenergic Agonist Combination Products).
Serious Asthma-Related Events with Inhaled Corticosteroid/Long-acting Beta2- adrenergic Agonist Combination Products Four (4) large, 26-week, randomized, double-blind, active-controlled clinical safety trials were conducted to evaluate the risk of serious asthma-related events when LABA were used in fixed-dose combination with ICS compared with ICS alone in subjects with asthma.
Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol with budesonide, 1 trial compared fluticasone propionate/salmeterol with fluticasone propionate, and 1 trial compared mometasone furoate/formoterol with mometasone furoate.
The fourth trial included pediatric subjects aged 4 to 11 years and compared fluticasone propionate/salmeterol with fluticasone propionate. No safety study was conducted with BREO ELLIPTA. The primary safety endpoint for all 4 trials was serious asthma-related events (hospitalizations, intubations, death).
A single, blinded, independent, joint adjudication committee determined whether events were asthma related. 7-fold increase in this relative risk. Each individual trial met its pre-specified objective and demonstrated non-inferiority of ICS/LABA to ICS alone.
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For patients previously treated with mid- to high-dose corticosteroid-containing treatment, BREO ELLIPTA 200/25 mcg should be considered. For patients who do not respond adequately to one inhalation of BREO ELLIPTA 100/25 mcg once-daily, switching to one inhalation of BREO ELLIPTA 200/25 mcg once-daily may provide additional asthma control.
Administration BREO ELLIPTA should be administered once-daily at the same time every day (morning or evening) by oral inhalation only. Do not use BREO ELLIPTA more than once every 24 hours. After inhalation, patients should rinse their mouth with water (without swallowing).
Dosing in Special Populations Geriatrics No dosage adjustment is required in patients 65 years of age and older (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics). Page 28 of 74 Renal Insufficiency No dose adjustment is required for patients with renal impairment (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Renal Insufficiency).
Hepatic Insufficiency Fluticasone furoate systemic exposure (Cmax and AUC) increased by up to 3-fold in subjects with mild, moderate and severe hepatic impairment. Caution should be exercised when dosing patients with hepatic impairment as they may be more at risk of systemic adverse reactions associated with corticosteroids.
Patients should be monitored for corticosteroid-related side effects. No dosage adjustment is required for patients with mild hepatic impairment. For patients with moderate or severe hepatic impairment, the maximum dose is 100/25 mcg (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
Missed Dose If a dose is missed, the patient should be instructed to take the next dose when it is due. The patient should be instructed not to take an extra dose. OVERDOSAGE BREO ELLIPTA contains both fluticasone furoate and vilanterol.
There is no specific treatment for an overdose with fluticasone furoate/vilanterol combination therapy. The risks associated with overdosage for the individual components described below therefore apply to BREO ELLIPTA. Further management should be as clinically indicated or as recommended by regional Poison Control centres, where available.
Fluticasone Furoate Chronic overdosage (use at excessive doses for prolonged periods) may result in signs/symptoms of hypercorticism (see WARNINGS AND PRECAUTIONS). The potential for acute toxic corticosteroid effects following overdosage with BREO ELLIPTA is low.
2%) and an absence of acute drug related systemic findings in clinical trials, overdosage of fluticasone furoate is unlikely to require any treatment other than observation. Single- and repeat-dose trials of fluticasone furoate at doses of 50 to 4,000 mcg have shown fluticasone furoate to be well tolerated.
Decreases in mean serum cortisol were observed at dosages of 500 mcg or higher given once daily for 14 days. , angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, QTc […]
A meta-analysis of the 3 adult and adolescent trials did not show a significant increase in risk of a serious asthma- related event with ICS/LABA fixed-dose combination compared with ICS alone (Table 1). These trials were not designed to rule out all risk for serious asthma-related events with ICS/LABA compared with ICS.
Page 6 of 74 Table 1 Meta-analysis of Serious Asthma-Related Events in Subjects with Asthma Aged 12 Years and Older ICS/LABA (n=17,537)a ICS (n=17,552)a ICS/LABA vs. 44) ICS = Inhaled Corticosteroid; LABA = Long-acting Beta2-adrenergic Agonist.
a Randomized subjects who had taken at least 1 dose of study drug. Planned treatment used for analysis. b Estimated using a Cox proportional hazards model for time to first event with baseline hazards stratified by each of the 3 trials.
c Number of subjects with an event that occurred within 6 months after the first use of study drug or 7 days after the last date of study drug, whichever date was later. Subjects may have had one or more events, but only the first event was counted for analysis.
A single, blinded, independent, joint adjudication committee determined whether events were asthma related. The pediatric safety trial included 6,208 pediatric subjects aged 4 to 11 years who received ICS/LABA (fluticasone propionate/salmeterol inhalation powder) or ICS (fluticasone propionate inhalation powder).
7%) subjects randomized to ICS experienced a serious asthma-related event. There were no asthma-related deaths or intubations. 27). BREO ELLIPTA is not indicated in children or adolescents younger than 18 years of age. S. 34]). Use of background ICS was not required in SMART.
The increased risk of asthma-related death is considered a class effect of LABA monotherapy. , as rescue therapy for the treatment of acute episodes of bronchospasm). , salbutamol) to relieve acute symptoms such as shortness of breath, and advised to have this available for use at all times.
) should be Page 7 of 74 instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute symptoms while taking BREO ELLIPTA. Deterioration of Disease and Acute Episodes BREO ELLIPTA should not be initiated in patients with acutely deteriorating COPD or asthma, which may be a life-threatening condition.
The use of BREO ELLIPTA in this setting is inappropriate. COPD or asthma may deteriorate acutely over a period […]