AFREZZA Inhalation Powder (2021)

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BOXED WARNING SECTION

WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA [see Warnings and Precautions (5.1)] ...

1. Indications and Usage

AFREZZA is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use AFREZZA is not a substitute for long-acting insulin. AFREZZA ...

2. Dosage and Administration

2.1 Route of Administration AFREZZA should only be administered via oral inhalation using the AFREZZA Inhaler. AFREZZA is administered using a single inhalation per cartridge. 2.2 Dosage Information Administer ...

3. Dosage Forms and Strengths

AFREZZA (insulin human) Inhalation Powder is available as 4 unit, 8 unit and 12 unit single use cartridges to be administered via oral inhalation with the AFREZZA Inhaler only [see How Supplied/Storage ...

4. Contraindications

AFREZZA is contraindicated in patients with the following: During episodes of hypoglycemia Chronic lung disease, such as asthma or chronic obstructive pulmonary disease (COPD), because of the risk of acute ...

5. Warnings and Precautions

5.1 Acute Bronchospasm in Patients with Chronic Lung Disease Because of the risk of acute bronchospasm, AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD [see ...

6. Adverse Reactions

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of AFREZZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs That May Increase the Risk of Hypoglycemia The risk of hypoglycemia associated with AFREZZA use may be increased with antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, ...

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 ...

8.2. Lactation

Risk Summary There are no data on the presence of AFREZZA in human milk, the effects on the breastfed infant, or the effects on milk production. One small published study reported that exogenous insulin ...

8.4. Pediatric Use

AFREZZA has not been studied in patients younger than 18 years of age.

8.5. Geriatric Use

In the AFREZZA clinical studies, 381 patients were 65 years of age or older, of which 20 were 75 years of age or older. No overall differences in safety or effectiveness were observed between patients ...

8.6. Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of AFREZZA has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for AFREZZA in patients with hepatic impairment ...

8.7. Renal Impairment

The effect of renal impairment on the pharmacokinetics of AFREZZA has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. ...

10. Overdosage

Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3, 5.8)]. Mild episodes of hypoglycemia can usually be treated with oral glucose. Adjustments ...

11. Description

11.1 AFREZZA Cartridges AFREZZA consists of single-use plastic cartridges filled with a white powder containing insulin (human), which is administered via oral inhalation using the AFREZZA Inhaler only. ...

12.1. 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 ...

12.2. Pharmacodynamics

The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. The average pharmacodynamic profile [i.e., glucose lowering effect ...

12.3. Pharmacokinetics

Absorption The pharmacokinetic profiles for orally inhaled AFREZZA 4, 12, and 48 units from a study in 30 patients with type 1 diabetes are shown in Figure 3(B). The time to maximum serum insulin concentration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104 week carcinogenicity study, rats were given doses up to 46 mg/kg/day of the carrier and up to 1.23 mg/kg/day of insulin, by nose-only inhalation. No increased incidence of tumors was observed ...

14. Clinical Studies

14.1 Overview of Clinical Studies of AFREZZA for Diabetes Mellitus AFREZZA has been studied in adults with type 1 diabetes in combination with basal insulin. The efficacy of AFREZZA in type 1 diabetes ...

16.1. How Supplied

AFREZZA (insulin human) Inhalation Powder is available as 4 unit, 8 unit and 12 unit single-use cartridges. Three cartridges are contained in a single cavity of a blister strip. Each card contains 5 blister ...

16.2. Storage and Handling

Storage Not in Use: Refrigerated Storage 2-8°C (36-46°F) Sealed (Unopened) Foil Package May be stored until the Expiration Date* Sealed (Unopened) Blister Cards + Strips Must be used within ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions Instruct patients to read the Medication Guide before starting AFREZZA therapy and ...