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insulin inhalation (Exubera, Afrezza)

Exubera off the US market 2007 due to low usage [7] Afrezza FDA-approved June 2014 [9] Indications: - diabetes mellitus - must be used in combination with long-acting insulin [9] Contraindications: 1) smoking 2) chronic lung disease a) asthma b) COPD 3) baseline FEV1 < 70% predicted Dosage: - mealtime dosing* * patients win type 1 diabetes will still need to inject a long-acting insulin [9] 1 & 3 mg blister packs, equivalent to 3 & 8 units of insulin Inhaler size of eyeglass case - clean weekly - replace cutting disc that releases insulin every 2 weeks Pharmacokinectics: 1) inhaled by mouth 2) absorbed through the lungs 3) faster onset than regular insulin injected SQ - effective within 10 minutes Monitor: - pulmonary function testing a) prior to starting therapy, at 6 months, then annually b) stop if baseline FEV1 < 70% predicted or decline > 20% Adverse effects: 1) cough [3], bronchospasm [9] 2) long-term pulmonary effects? 3) effects in smokers or patients with lung disease not well understood 4) hypoglycemia [3] 5) increased risk of lung cancer [8,9] - case reports in smokers Mechanism of action: 1) powder form of regular insulin 2) absorbed through the lungs. 3) works as well as injectable regular insulin to lower blood glucose Notes: - FDA is requiring post-marketing studies for Afrezza: - a clinical trial to evaluate pharmacokinetics, safety & efficacy in pediatric patients - a clinical trial to evaluate risk of lung cancer (trial also to assess cardiovascular risk & long-term effect on pulmonary function) - 2 clinical trials on pharmacokinetic-pharmacodynamic euglycemic glucose-clamp - dose-response - within-subject variability

Interactions

drug adverse effects of hypoglycemic agents

General

pharmaceutical insulin short-acting insulin aerosolized agent

References

  1. Prescriber's Letter 12(9): 2005 Diabetes Drugs on the Horizon: Orally Inhaled Insulin (Exubera) Detail-Document#: 210905 (subscription needed) http://www.prescribersletter.com
  2. DeFronzo RA et al. Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: A 12-week, randomized, comparative trial. Diabetes Care 2005 Aug; 28:1922-8. PMID: 16043733
  3. Rosenstock J, Zinman B, Murphy LJ, Clement SC, Moore P, Bowering CK, Hendler R, Lan SP, Cefalu WT. Inhaled insulin improves glycemic control when substituted for or added to oral combination therapy in type 2 diabetes: a randomized, controlled trial. Ann Intern Med. 2005 Oct 18;143(8):549-58. Summary for patients in: Ann Intern Med. 2005 Oct 18;143(8):I28. PMID: 16230721
  4. Prescriber's Letter 13(3): 2006 Detail-Document#: 220308 (subscription needed) http://www.prescribersletter.com
  5. Prescriber's Letter 13(3): 2006 Insulin for oral inhalation (Exubera) Detail-Document#: 220701 (subscription needed) http://www.prescribersletter.com
  6. Pifzer Labs http://www.exubera.com
  7. Prescriber's Letter 14(11): 2007 Exubera Off the Market Detail-Document#: 231105 (subscription needed) http://www.prescribersletter.com
  8. FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#exubera
  9. Young K FDA Advisers Back New Inhaled Insulin Physician's First Watch, April 3, 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - FDA News Release. June 27, 2014. FDA approves Afrezza to treat diabetes http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403122.htm