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ATECTURA BREEZHALER is a brand name for Indacaterol, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ATECTURA BREEZHALER (indacaterol/mometasone furoate) is a combination of a long-acting beta2- adrenergic agonist (LABA) and an inhaled corticosteroid (ICS) indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. ATECTURA…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients should be made aware that ATECTURA BREEZHALER should be used regularly, even when asymptomatic. When treating patients with asthma, physicians should only prescribe ATECTURA BREEZHALER 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 a LABA and an inhaled corticosteroid.
Patients should be given the strength of ATECTURA BREEZHALER containing the appropriate mometasone furoate dosage for the severity of their disease and should be regularly reassessed by a healthcare professional. If a previously effective dose of ATECTURA BREEZHALER fails to provide ATECTURA® BREEZHALER® Product Monograph Page 5 of 39 adequate control of asthma symptoms, patients should seek medical advice as this indicates worsening of their underlying condition.
As with other inhaled drugs containing beta2-adrenergic agents, ATECTURA BREEZHALER 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 ATECTURA BREEZHALER. It is crucial to inform patients that ATECTURA BREEZHALER should not be used to treat acute symptoms of asthma.
, salbutamol) to relieve the acute symptoms such as shortness of breath and advised to have this available for use at all times. 2 Recommended Dose and Dosage Adjustment The recommended dose of ATECTURA BREEZHALER for patients 12 years of age and older is: Inhalation of the content of one capsule of ATECTURA BREEZHALER 150/80 micrograms once-daily is recommended in patients who require a combination of a long-acting beta2-agonist and a low dose of inhaled corticosteroid.
Inhalation of the content of one capsule of ATECTURA BREEZHALER 150/160 micrograms or 150/320 micrograms once-daily is recommended in patients who require a combination of a long-acting beta2-agonist and a medium or high dose of inhaled corticosteroid.
The maximum recommended dose is ATECTURA BREEZHALER 150/320 micrograms once-daily. Dosing in special populations Renal impairment No dose adjustment is required in patients with renal impairment (see Special Populations and Conditions, Renal Insufficiency).
1 Adverse Reaction Overview Use of LABA monotherapy (without ICS treatment) increases the risk of serious asthma-related events (death, hospitalizations, and intubations) (see General). Data from Study B2301 were used to determine the frequency of adverse reactions associated with ATECTURA BREEZHALER.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The safety of ATECTURA BREEZHALER was evaluated in phase 3 studies with a total of 2497 adult or adolescent patients with asthma treated with ATECTURA BREEZHALER 150/80, 150/160 or 150/320 micrograms once-daily for up to 52 weeks.
The most common adverse drug reactions related to ATECTURA BREEZHALER were headache, musculoskeletal pain, oropharyngeal pain, dysphonia, and hypersensitivity. Adverse drug reactions (Table 3) are listed by MedDRA system organ class.
Similar adverse event profile was observed in a 12-week clinical study (B2303). 62 * Indicates grouping of preferred terms (PTs) observed in the three Phase 3 studies. 1 oral candidiasis, oropharyngeal candidiasis. 2 drug eruption, drug hypersensitivity, hypersensitivity, rash, rash erythematous, rash pruritic, urticaria.
3 blood glucose increased, hyperglycaemia. 4 headache, tension headache. 5 oral pain, oropharyngeal discomfort, oropharyngeal pain, throat irritation, odynophagia. 6 back pain, musculoskeletal pain, myalgia, neck pain, musculoskeletal chest pain.
3 Less Common Clinical Trial Adverse Reactions Adverse drug reactions with <1% estimated cumulative incidence (%) in study B2301 at 52 weeks: angioedema, tachycardia, rash, pruritus, muscle spasms. 5 Post-Market Adverse Reactions No post marketing Adverse Drug Reactions have been identified to date for ATECTURA BREEZHALER.
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 ATECTURA BREEZHALER. 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.
ATECTURA BREEZHALER is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 Dosage Forms, Strengths, Composition and Packaging.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatic impairment No data are available for ATECTURA BREEZHALER in subjects with hepatic impairment. e. indacaterol and mometasone furoate), no dose adjustment is required in patients with mild or moderate hepatic impairment; however, ATECTURA BREEZHALER may be used in patients with severe hepatic impairment only if the expected benefit outweighs the potential risk (see Special Populations and Conditions, Hepatic Insufficiency).
Elderly patients (65 years or above) No dose adjustment is required in elderly patients 65 years of age or older (see 10 CLINICAL PHARMACOLOGY). Pediatrics (below 12 years) The safety and efficacy of ATECTURA BREEZHALER in pediatric patients below 12 years of age have not been established (see Special Populations and Conditions, Pediatrics).
4 Administration For inhalation use only. ATECTURA BREEZHALER capsules must not be swallowed. Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the capsule rather than inhaling it.
The capsules must be administered only using the ATECTURA BREEZHALER inhaler. The inhaler provided with each new prescription should be used. ATECTURA BREEZHALER should be administered at the same time of the day each day. It can be administered irrespective of the time of the day.
The capsules must always be stored in the blister to protect from moisture and light, and only removed immediately before use (see 12 SPECIAL HANDLING INSTRUCTIONS). After inhalation, patients should rinse their mouth with water without swallowing.
5 Missed Dose If a dose is missed, it should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.
ATECTURA® BREEZHALER® Product Monograph Page 16 of 39
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 2). These trials were not designed to rule out all risk for serious asthma-related events with ICS/LABA compared with ICS.
Table 2 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). ATECTURA BREEZHALER is not indicated in children younger than 12 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 instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute symptoms while taking ATECTURA BREEZHALER. Deterioration of Disease ATECTURA BREEZHALER should not be initiated in patients with acutely deteriorating asthma, which may be a life-threatening condition.
The use of ATECTURA BREEZHALER in this […]