Exubera

Exubera

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Questions & Answers

Side Effects & Adverse Reactions

EXUBERA differs from regular human insulin by its rapid onset of action. When used as mealtime insulin, the dose of EXUBERA should be given within 10 minutes before a meal.

Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA. The timing of hypoglycemia may differ among various insulin formulations.

Patients with type 1 diabetes also require a longer-acting insulin to maintain adequate glucose control.

Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., regular, NPH, analogs), or species (animal, human) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted.

Glucose monitoring is recommended for all patients with diabetes.

Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (see PRECAUTIONS: Pulmonary Function).

The use of EXUBERA in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of EXUBERA in this population have not been established (see PRECAUTIONS: Underlying Lung Disease).

In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator-treated patients. There has also been 1 postmarketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

EXUBERA is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in combination with oral agents or longer-acting insulins.

History

There is currently no drug history available for this drug.

Other Information

EXUBERA® consists of blisters containing human insulin inhalation powder, which are administered using the EXUBERA® Inhaler. EXUBERA 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:

Chemical Structure

EXUBERA (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 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 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 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
Fill Mass
(mg powder)
Nominal Dose
(mg insulin)
Emitted Dose*,
(mg insulin)
Fine Particle Dose‡,
(mg insulin)
*
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
1.7 1.0 0.53 0.4
5.1 3.0 2.03 1.0

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.

Exubera Manufacturers


  • Pfizer Inc.
    Exubera (Insulin Human) Exubera (Insulin Human) Aerosol, Powder [Pfizer Inc.]

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