Clinical Information
Gen. Code and Des.
73243 insulin regular, human INHALATION CART INHAL 8 UNIT
GCN and Des.
37621 insulin regular, human INHALATION CART INHAL 8 UNIT
Strength
8UN
Dose Form
CARTRIDGE WITH INHALER
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200804 RAPID-ACTING INSULINS
68200800 INSULINS
Active Ingredients
869 insulin regular, human 11061680
Inactive Ingredients
2551 polysorbates 9005645
Item info. These highlights do not include all the info. needed to use AFREZZA safely and effectively. See full prescribing info. for AFREZZA . AFREZZA (insulin human) Inhalation Powder Initial U.S. Approval: 2014 WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE See full prescribing info. for complete boxed warning. Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. Before initiating AFREZZA, perform detailed medical history, physical examination, and spirometry (FEV ) to identify potential lung disease in all patients. , INDICATIONS AND USAGE AFREZZA is rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Important limitations of use: In patients with type diabetes, must use with long-acting insulin. Not recommended for the treatment of diabetic ketoacidosis. Not recommended in patients who smoke DOSAGE AND ADMINISTRATION Administer using single inhalation per cartridge Administer at the beginning of meal Dosing must be individualized Before initiating, perform detailed medical history, physical examination, and spirometry (FEV ) in all patients to identify potential lung disease DOSAGE FORMS AND STRENGTHS AFREZZA is available as single-use cartridges of: 4 units 8 units 12 units CONTRAINDICATIONS During episodes of hypoglycemia Chronic lung disease, such as asthma, or chronic obstructive pulmonary disease Hypersensitivity to regular human insulin or any of the AFREZZA excipients ARNINGS AND PRECAUTIONS Acute Bronchospasm: Acute bronchospasm has been observed in patients with asthma and COPD. Before initiating, perform spirometry (FEV ) in all patients. Do not use in patients with chronic lung disease. (2.5, 4, 5.1) Change in Insulin Regimen: Carry out under close medical supervision and increase frequency of blood glucose monitoring. Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. (5.3, 6, 7, 8.6, 8.7) Decline in Pulmonary Function: Assess pulmonary function (e.g., spirometry) before initiating, after months of therapy, and annually, even in the absence of pulmonary symptoms. (2.5, 5.4) Lung Cancer: AFREZZA should not be used in patients with active lung cancer. In patients with history of lung cancer or at risk for lung cancer, the benefit of AFREZZA use should outweigh this potential risk. Diabetic Ketoacidosis: More patients using AFREZZA experienced diabetic ketoacidosis in clinical trials. In patients at risk for DKA, monitor and change to alternate route of insulin delivery, if indicated. Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including AFREZZA. Discontinue AFREZZA, monitor and treat if indicated. Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ADVERSE REACTIONS The most common adverse reactions associated with AFREZZA (2% or greater incidence) are hypoglycemia, cough, and throat pain or irritation. To report SUSPECTED ADVERSE REACTIONS, contact MannKind at (1-877-323-8505) or FDA at (1-800-FDA-1088) or www.fda.gov/medwatch. DRUG INTERACTIONS Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. (7.1, 7.2, 7.3) Anti-Adrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. (7.3, 7.4) See 17 for PATIENT COUNSELING info. and Medication Guide. Revised: 04/201