AFREZZA Dosage & Rx Info | Uses, Side Effects

Afrezza Generic Name & Formulations

Legal Class

General Description

Insulin (human, recombinant) 4 Units, 8 Units, 12 Units; per cartridge; pwd for oral inhalation.

How Supplied

Single-use cartridges—90 (4 Units + inhalers; 8 Units + inhalers; 12 Units + inhalers), 180 (90 x 8 Units + 90 x 12 Units + inhalers); Titration pack—180 (90 x 4 Units + 90 x 8 Units + inhalers; 60 x 4 Units + 60 x 8 Units + 60 x 12 Units + inhalers)

Manufacturer

Mannkind Corporation

Generic Availability

Mechanism of Action

Insulin lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.

Afrezza Indications

Indications

Diabetes.

Limitations of Use

Not for treatment of diabetic ketoacidosis. Not for use in smokers or those who have recently stopped smoking.

Afrezza Dosage and Administration

Adult

Administer at beginning of the meal. May need to adjust dose when switching from another insulin. Onset ~12mins, peak ~35–55mins, duration ~1.5–4.5hrs. 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.

Children

<18yrs: not established.

Afrezza Contraindications

Contraindications

During episodes of hypoglycemia. Chronic lung disease (eg, asthma or COPD).

Afrezza Boxed Warnings

Boxed Warning

Risk of acute bronchospasm in patients with chronic lung disease (eg, asthma, COPD).

Afrezza Warnings/Precautions

Warnings/Precautions

Risk for 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 of or risk for lung cancer. Increased risk for 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; lower doses may be needed. Pregnancy. Nursing mothers.

Afrezza Pharmacokinetics

Absorption

Onset ~12mins, peak effect ~35–55mins, duration ~1.5–4.5hrs. The time to maximum serum insulin concentraiton (t_max) ranged from 10–20mins.

Elimination

Half-life: 120–206 minutes.

Afrezza Interactions

Interactions

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.

Afrezza Adverse Reactions

Adverse Reactions

Hypoglycemia, cough, throat pain or irritation; hypokalemia (monitor).

Afrezza Clinical Trials

See Literature

Afrezza Note

Not Applicable

Afrezza Patient Counseling