Insulin human

AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis (DKA) ( 1 ) Not recommended in patients who smoke or who have recently stopped smoking ( 1 ) Limitations of Use: AFREZZA is not recommended for the treatment of diabetic ketoacidosis (DKA) [see Warnings and Precautions ( 5.6 )] . …

• Only administer via oral inhalation using the AFREZZA inhaler Administer at the beginning of each meal See full prescribing information for the recommended starting mealtime dosage in insulin-naïve patients and patients who are using subcutaneous mealtime insulin, or pre-mixed insulin Modify the mealtime AFREZZA dosage based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal If blood glucose control is not achieved with increased AFREZZA dosages, consider discontinuing AFREZZA Lung Function Assessment Prior to Administration AFREZZA is contraindicated in patients with chronic lung disease because of the risk of acute bronchospasm in these patients
• Before initiating AFREZZA, perform a medical history, physical examination and spirometry (FEV 1 ) in all patients to identify potential lung disease [see Contraindications and Warnings and Precautions ]
• Important Administration Information Prior to initiation, train patients and/or their caregiver(s) on proper administration of AFREZZA
• After training, adult and pediatric patients aged 10 and older may self-administer AFREZZA if the healthcare provider determines that it is appropriate
• Refer patients to the Instructions for Use for detailed instructions and visuals on how to prepare, administer, and store AFREZZA; use the AFREZZA cartridges; and use the AFREZZA inhaler
• Only administer AFREZZA via oral inhalation using the AFREZZA Inhaler
• Administer AFREZZA at the beginning of each meal. …

Inhalation Powder: 3 single-use cartridges of insulin human as white powder labeled “afrezza”. Each AFREZZA inhalation cartridge delivers: 4 units (blue cartridge) 8 units (green cartridge) 12 units (yellow cartridge) Inhalation powder in single-use cartridges of: 4 units, 8 units, or 12 units ( 3 )

• The safety and effectiveness of AFREZZA to improve glycemic control have been established
• In pediatric patients 6 years of age and older with diabetes mellitus
• Use of AFREZZA for this indication is supported by evidence from an adequate and well controlled trial
• In pediatric patients aged 6 years and older with type 1 or type 2 diabetes mellitus and from trials
• In adults with type 1 or type 2 diabetes mellitus [see Adverse Reactions , Clinical Studies ]
• The overall safety profile
• In pediatric patients was similar to adults [see Adverse Reactions ] . …

In the AFREZZA clinical studies , 671 (12%) patients were 65 years of age or older, of which 42 (0.8%) were 75 years of age or older. In these studies, 381 (13%) of AFREZZA-treated patients were 65 years of age or older, of which 20 (0.7%) were 75 years of age or older. No overall differences in effectiveness of AFREZZA have been observed between patients 65 years of age and older and younger adult patients [see Clinical Studies ( 14 )] . …

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use )
• Instruct patients to use AFREZZA only with the AFREZZA inhaler
• Acute Bronchospasm in Patients with Chronic Lung Disease Advise patients that if they experience any respiratory difficulty after inhalation of AFREZZA, they should report it to their healthcare provider immediately for assessment [see Warnings and Precautions ]
• Hypoglycemia Instruct patients on self-management procedures including glucose monitoring, proper inhalation technique, and management of hypoglycemia and hyperglycemia, especially at initiation of AFREZZA therapy. …

• AFREZZA is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ]
• In patients with chronic lung disease, such as asthma or COPD, because of the risk of acute bronchospasm [see Warnings and Precautions ]
• In patients with a previous severe hypersensitivity reaction to any regular human insulin product or any of the inactive ingredients in AFREZZA. …

2.5 Dosage Modifications for Drug Interactions Dosage modification may be needed when: AFREZZA is used concomitantly with certain drugs that increase and/or decrease the glucose lowering effect [see Drug Interactions ( 7 )]. Switching from another insulin to AFREZZA [see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.2 )] 7 DRUG INTERACTIONS Table 6 presents clinically significant drug interactions with AFREZZA. Table 6. …

Hypoglycemia or Hyperglycemia with Changes in Insulin Regimen : Make necessary changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. For patients with type 2 diabetes mellitus, oral antidiabetic treatment dosage modifications may be needed. ( 5.2 ) Hypoglycemia (may be life-threatening): Increase frequency of glucose monitoring in patients at higher risk for hypoglycemia and those who have reduced symptomatic awareness of hypoglycemia. …

The following serious adverse reactions are described below and elsewhere in the labeling: Acute bronchospasm in patients with chronic lung disease [see Warnings and Precautions ( 5.1 )] Hypoglycemia [see Warnings and Precautions ( 5.3 )] Decline in pulmonary function [see Warnings and Precautions ( 5.4 )] Lung cancer [see Warnings and Precautions ( 5.5 )] Diabetic ketoacidosis [see Warnings and Precautions ( 5.6 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.7 )] The most common adverse reactions associated with AFREZZA (2% or greater incidence) are hypoglycemia, cough, and throat pain or irritation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact MannKind at 1-877-323- …

8.1 Pregnancy Risk Summary Limited available data with AFREZZA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. Available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental outcomes ( see Data ). …

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.8 )] . Mild episodes of hypoglycemia due to insulin overdose can usually be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed. Severe episodes of hypoglycemia (due to insulin overdose) with coma, seizure, or neurologic impairment may be treated with intramuscular or subcutaneous glucagon or concentrated intravenous glucose. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.