"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
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].
- AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. [see CONTRAINDICATIONS].
- Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
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.
AFREZZA cartridges contain human insulin produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Chemically, human insulin has the empirical formula C257H383N65O77S6 and a molecular weight of 5808. Human insulin has the following primary amino acid sequence:
Insulin is adsorbed onto carrier particles consisting of fumaryl diketopiperazine (FDKP) and polysorbate 80.
AFREZZA Inhalation Powder is a dry powder supplied as 4 unit, 8 unit or 12 unit cartridges. The 4 unit cartridge contains 0.35 mg of insulin. The 8 unit cartridge contains 0.7 mg of insulin. The 12 unit cartridge contains 1.0 mg of insulin.
The AFREZZA Inhaler is breath-powered by the patient. When the patient inhales through the device, the powder is aerosolized and delivered to the lung. The amount of AFREZZA delivered to the lung will depend on individual patient factors.
Last reviewed on RxList: 5/5/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Afrezza Information
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