Presentation on theme: "Inhaled Human Insulin and its Place in Therapy"— Presentation transcript:
1Inhaled Human Insulin and its Place in Therapy Breanne Fleming, PharmDPGY2 Ambulatory Care ResidentRichard L. Roudebush VA Medical CenterThis speaker has no actual or potential conflicts of interest to disclose in relation to this presentation
2Exubera® Inhaled Human Insulin Introduced in mid 2006-1 or 3 mg blisters; 3 mg = 8 unitsSimilar onsetSimilar CI and precautionsMack GS. Nat Biotechnol Dec;25(12):
3Exubera® Inhaled Human Insulin ChallengesSize of deviceDifficult dose adjustmentDosage form inconsistenciesRisk of lung diseaseInsurance barriersWithdrawn from the market in 2007Issues with insurance companies covering because it was not BETTER than subQ but cost 30% moreRemoved from the market in 2007 d/t lack of consumer interest.Other drug companies stopped development of their own inhaled insulin products – with the exception of the makers of AfrezzaMack GS. Nat Biotechnol Dec;25(12):Business Week. Pfizer’s Exubera Flop. Available at: Accessed July 25, 2014.
4Afrezza® Inhaled Human Insulin FDA approved June 2014Patients with type 1 and type 2 diabetesUltra rapid-acting insulinNot yet availableSimilar onsetSimilar CI and precautionsSmaller and more convenient designSingle-use cartridges, powdered regular insulin – inhaler is used to aerosolize that powder for absorption.Afrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
10Storage Store in refrigerator Inhaler good for 15 days from date of first use – then discard and replace with new inhalerAfrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
11Initiating Inhaled Insulin Insulin naïveStart 4 units at each mealPatients on subcutaneous mealtime insulinAfrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
12Adverse Reactions Hypoglycemia Cough Throat pain/irritation Acute bronchospasm in patients with chronic lung diseaseDecline in pulmonary functionLung cancerDiabetic ketoacidosis (DKA)Hypersensitivity reactionsREMS for bronchospasmCheck pulmonary function even if no symptoms – consider d/c if pt experiences >20% decline in FEV1 from baselinePulmonary function Spirometry at baseline, 6 months, then annuallyresolved with discontinuation of inhaled insulin4 cases of lung cancer so far, same risk with ExuberaPatients at increased risk for DKAMore patients experienced DKA vs. subcutaneous insulin (0.43% vs. 0.14%) very small sample sizeAfrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
13Contraindications Patients with chronic lung disease AsthmaCOPDHistory of hypersensitivity to regular human insulin or any excipientsAfrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.
14Pharmacokinetics Clinical Effect Absorption A = onset of activity no difference vs. lisproB = max serum concentrationsRegular insulin hours duration 8 hoursAfrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014..
15*OAD= max dose metformin or >2 oral antidiabetic agents Clinical EvidencePopulation:Patients with T2DMIntervention:Inhaled insulin + OAD*vs.placebo + OAD**OAD= max dose metformin or >2 oral antidiabetic agentsPrimary Outcome:Reduction in HgbA1cAfrezza(R) [package insert]. Danbury, CT: MannKind Corporation; 2014.