Generic Name and Formulations:
Insulin (human, recombinant) 4 Units, 8 Units, 12 Units; per cartridge; pwd for oral inhalation.
Indications for AFREZZA:
Limitations Of use:
Not a substitute for long-acting insulin. Must be used in combination with long-acting insulin in patients with type 1 diabetes. Not for treatment of diabetic ketoacidosis. Smokers or recently stopped smoking: not recommended.
Administer at beginning of the meal. May need to adjust dose when switching from another insulin. Individualize. ≥18yrs: Insulin-naïve: initially 4 Units at each meal. Patients using SC mealtime prandial insulin: convert dose to Afrezza using conversion table (see full labeling). Patients using SC pre-mixed insulin: divide ½ of total daily injected pre-mixed insulin dose equally among 3 meals of the day; convert dose to Afrezza using table (see full labeling). Give ½ of total daily injected pre-mixed dose as injected basal insulin dose. Mealtime dose adjustments: see full labeling.
<18yrs: not established.
During episodes of hypoglycemia. Chronic lung disease (eg, asthma or COPD).
Risk of acute bronchospasm; evaluate for underlying lung disease prior to initiation. Assess pulmonary function at baseline, after first 6 months, and yearly thereafter; consider discontinuing if FEV1 decline ≥20% from baseline. Discontinue if pulmonary symptoms (eg, wheezing, cough) persist. Increased risk of hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen, or if acute illness occurs: monitor and may need to adjust dose. Monitor blood glucose (esp. high doses); consider SC mealtime insulin if inadequate control. History or risk of lung cancer. Increased risk of diabetic ketoacidosis in acute illness or infection; monitor glucose more frequently and consider alternate insulin delivery. Discontinue if hypersensitivity reactions occur. Hepatic or renal impairment: monitor frequently and adjust dose if needed. Pregnancy. Nursing mothers.
Caution with K+-depleting drugs or those sensitive to serum K+ concentrations; may cause hypokalemia. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Increased risk of hypoglycemia with concomitant antidiabetics, ACEIs, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (eg, octreotide), sulfonamides; monitor more frequently and adjust dose as needed. May be antagonized by concomitant atypical antipsychotics (eg, olanzapine, clozapine), steroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, protease inhibitors, somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), thyroid hormones; monitor more frequently and adjust dose if needed. May be affected by alcohol, β-blockers, clonidine, lithium salts, pentamidine; monitor more frequently and adjust dose if needed. Concomitant β-blockers, clonidine, guanethidine, or reserpine may mask hypoglycemia.
Hypoglycemia, cough, throat pain or irritation; hypokalemia (monitor).
Single-use cartridges—90 (4 Units + inhalers); Co-packages—90 (60 x 4 Units + 30 x 8 Units + inhalers); (30 x 4 Units + 60 x 8 Units + inhalers); (60 x 8 Units + 30 x 12 Units + inhalers); Titration pack—180 (90 x 4 Units + 90 x 8 Units + inhalers)