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UK-RES-2101606 August 2021

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UK-RES-2101574 August 2021

Atimos® Formoterol pMDI logo with device

Asthma: Licensed in adults and adolescents 12 years and above
COPD: Licensed in adults 18 years and above

Asthma: Licensed in adults and
adolescents 12 years and above
COPD: Licensed in adults 18 years and above

Asthma: Licensed in adults and adolescents 12 years and above
COPD: Licensed in adults 18 years and above

Atimos® Data Summary1

Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. The onset of action is observed within one to three minutes. Significant bronchodilation is still present 12 hours after inhalation. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge.

As with other substances administered by inhalation, 90% of the inhaled formoterol dose is swallowed and absorbed from the gastrointestinal tract. The pharmacokinetic characteristics of the oral formulation can thus be extrapolated to the inhalation of metered aerosol.

Absorption is both rapid and extensive; after inhalation of a therapeutic dose (12 micrograms) of Atimos pressurised inhalation solution in asthmatic patients, the peak plasma concentration is observed approximately 15 minutes after inhalation, earlier than that observed with a formoterol powder inhalation. Generally, absorption rate should be taken into account when switching patients from one formoterol formulation to another.

Absorption of formoterol is linear following inhalation of 12 micrograms to 96 micrograms of formoterol fumarate dihydrate.

Oral doses of up to 300 micrograms of formoterol are rapidly absorbed from the gastrointestinal tract. The peak plasma concentration of the unchanged substance is reached after 30 minutes to 1 hour. More than 65% of an oral dose of 80 micrograms is absorbed.

Dose linearity is present within a dose range of 20 micrograms to 300 micrograms (oral administration).

Repeated daily administration of 40-160 micrograms per day does not result in accumulation because of the short half-life. The pharmacokinetics of formoterol do not differ significantly between men and women.

Plasma protein binding is 61% to 64% (34% to albumin); binding sites are not saturated at therapeutic dose levels.

Formoterol is metabolised primarily via direct glucuronisation and is eliminated completely. A further route of biotransformation is O-demethylation followed by glucuronisation with consecutive complete elimination.

Multiple CYP450 isozymes catalyze the transformation (2D6, 2C19, 2C9, and 2A6) and consequently the potential for metabolic drug-drug interaction is low. The kinetics of formoterol are similar after single and repeated administration, indicating no auto-induction or inhibition of metabolism.

The elimination of formoterol apparently follows a polyphasic pattern, and the half-life described is therefore dependent on the time intervals considered. Based on plasma or blood concentrations measured 6, 8 or 12 hours after oral administration, an elimination half-life of 2 to 3 hours was determined. A half-life of 5 hours was calculated from the renal excretion rate between 3 and 16 hours after inhalation.

The active substance and metabolites are eliminated completely, two thirds of an oral administered dose with the urine, one third with the faeces. Following inhalation of formoterol, a mean of 6% to 9% of the substance is eliminated unchanged with the urine. Renal clearance of formoterol is 150ml/min.

For additional information to share with your patients who have been prescribed Atimos, please visit our Atimos patient and carer site.

1. Atimos Summary of Product Characteristics. Chiesi Limited.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.