resence of fluticasone propionate or salmeterol in humanmilk, the effects on the breastfed child, or the effects on milk production. Other corticosteroidshave been detected in human milk. However, fluticasone propionate and salmeterolconcentrations in plasma after inhaled therapeutic doses are low and therefore concentrations inhuman breast milk are likely to be correspondingly low [see Clinical Pharmacology (12.3)]. Thedevelopmental and health benefits of breastfeeding should be considered along with the mother’sclinical need for AirDuo Digihaler and any potential adverse effects on the breastfed child from
AirDuo Digihaler or from the underlying maternal condition.
Data
Animal Data
Subcutaneous administration of tritiated fluticasone propionate at a dose in lactating ratsapproximately 0.2 times the MRHDID for adults (on a mcg/m2basis) resulted in measurablelevels in milk. Oral administration of salmeterol at a dose in lactating rats approximately 2900times the MRHDID for adults (on a mcg/m2basis) resulted in measurable levels in milk.
8.4 Pediatric Use
The safety and effectiveness of AirDuo Digihaler in the treatment of asthma in pediatric patientsaged 12 years and older whose asthma (1) is inadequately controlled on a long term asthmacontrol medication or (2) warrants initiation of treatment with both an ICS and a LABA has beenestablished. Use of AirDuo Digihaler for this indication was supported by evidence from twoadequate and well-controlled trials in pediatric patients 12 years old and older with persistentsymptomatic asthma despite ICS or ICS/LABA therapy (Trials 1 and 2) [see Clinical Studies(14)]. In these trials, 58 adolescents received fluticasone propionate/salmeterol MDPI one
inhalation twice daily.
The safety and effectiveness of AirDuo Digihaler in pediatric patients below the age of 12 yearshave not been established.
Inhaled corticosteroids, including fluticasone propionate, a component of AirDuo Digihaler, maycause a reduction in growth velocity in adolescents [see Warning and Precautions (5.13)]. Thegrowth of pediatric patients receiving ICS, including AirDuo Digihaler, should be monitored.
If an adolescent on any corticosteroid appears to have growth suppression, the possibility thathe/she is particularly sensitive to this effect of corticosteroids should be considered. In suchpatients, the potential growth effects of prolonged ICS treatment should be weighed against theclinical benefits obtained. To minimize the systemic effects of ICS, including AirDuo Digihaler,each patient should be titrated to the lowest strength that effectively controls his/her asthma [seeDosage and Administration (2)].
8.5 Geriatric Use
No overall differences in safety or effectiveness were observed in data collected in 54 subjectsaged 65 years and older versus younger subjects who were treated with fluticasonepropionate/salmeterol MDPI in placebo-controlled Phase 2 and 3 asthma studies.
8.6 Hepatic Impairment
Formal pharmacokinetic studies using AirDuo Digihaler have not been conducted in patientswith hepatic impairment. However, since both fluticasone propionate and salmeterol arepredominantly cleared by hepatic metabolism [see Clinical Pharmacology (12.3)], impairmentof liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma.
Therefore, patients with hepatic impairment should be closely monitored.
8.7 Renal Impairment
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