"The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is adminis"...
Exubera (insulin human rdna origin)
(insulin human [rdna origin]) Aerosol, Powder
EXUBERA (insulin human rdna origin) ® consists of blisters containing human insulin inhalation powder, which are administered using the EXUBERA (insulin human rdna origin) ® Inhaler. EXUBERA (insulin human rdna origin) blisters 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:
EXUBERA (insulin human rdna origin) (insulin human [rDNA origin]) Inhalation Powder is a white to off-white powder in a unit dose blister (fill mass, see Table 1). Each unit dose blister of EXUBERA (insulin human rdna origin) contains a 1 mg or 3 mg dose of insulin (see Table 1) in a homogeneous powder formulation containing sodium citrate (dihydrate), mannitol, glycine, and sodium hydroxide. After an EXUBERA (insulin human rdna origin) blister is inserted into the inhaler, the patient pumps the handle of the inhaler and then presses a button, causing the blister to be pierced. The insulin inhalation powder is then dispersed into the chamber, allowing the patient to inhale the aerosolized powder.
Under standardized in vitro test conditions, EXUBERA (insulin human rdna origin) delivers a specific emitted dose of insulin from the mouthpiece of the inhaler (see Table 1). A fraction of the total particle mass is emitted as fine particles capable of reaching the deep lung. Up to 45% of the 1 mg blister contents, and up to 25% of the 3 mg blister contents, may be retained in the blister.
Table 1: Dose Nomenclature and Information
|Fine Particle Dose‡,†
|Flow rate of 30 L/min for 2.5 seconds
† Emitted dose and fine particle dose information are not intended to predict actual pharmacodynamic response.
‡Flow rate of 28.3 L/min for 3 seconds
The actual amount of insulin delivered to the lung will depend on individual patient factors, such as inspiratory flow profile. In vitro, emitted aerosol metrics are unaffected at flow rates above 10 L/min.
Last reviewed on RxList: 12/11/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Exubera Information
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