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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
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Manufacturer Warnings
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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:
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.
Fill Mass (mg powder) |
Nominal Dose (mg insulin) |
Emitted Dose*,† (mg insulin) |
Fine Particle Dose‡,† (mg insulin) |
---|---|---|---|
|
|||
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.
Sources
Exubera Manufacturers
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Pfizer Inc.
Exubera | Pfizer Inc.
EXUBERA, like rapid-acting insulin analogs, has a more rapid onset of glucose-lowering activity compared to subcutaneously injected regular human insulin. EXUBERA has a duration of glucose-lowering activity comparable to subcutaneously injected regular human insulin and longer than rapid-acting insulin. EXUBERA doses should be administered immediately prior to meals (no more than 10 minutes prior to each meal).
In patients with type 1 diabetes, EXUBERA should be used in regimens that include a longer-acting insulin. For patients with type 2 diabetes, EXUBERA may be used as monotherapy or in combination with oral agents or longer-acting insulin.
Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA. Periodic monitoring of pulmonary function is recommended for patients being treated with EXUBERA (see PRECAUTIONS, Pulmonary Function).
EXUBERA is intended for administration by inhalation and must only be administered using the EXUBERA® Inhaler. Refer to the EXUBERA Medication Guide for a description of the EXUBERA® Inhaler and for instructions on how to use the inhaler.
Calculation of Initial Pre-Meal EXUBERA DoseThe initial dosage of EXUBERA should be individualized and determined based on the physician's advice in accordance with the needs of the patient. Recommended initial pre-meal doses are based on clinical trials in which patients were requested to eat three meals per day. Initial pre-meal doses may be calculated using the following formula: [Body weight (kg) X 0.05 mg/kg = pre-meal dose (mg)] rounded down to the nearest whole milligram number (e.g., 3.7 mg rounded down to 3 mg).
Approximate guidelines for initial, pre-meal EXUBERA doses, based on patient body weight, are indicated in Table 7:
Table 7: Approximate Guidelines for Initial, Pre-Meal EXUBERA Dose (based on patient body weight) Patient Weight
(in kg) Patient Weight
(in lb) Initial Dose per Meal Number of 1 mg Blisters per Dose Number of 3 mg Blisters per Dose 30 to 39.9 kg 66 – 87 lb 1 mg per meal 1 - 40 to 59.9 kg 88 – 132 lb 2 mg per meal 2 - 60 to 79.9 kg 133 – 176 lb 3 mg per meal - 1 80 to 99.9 kg 177 – 220 lb 4 mg per meal 1 1 100 to 119.9 kg 221– 264 lb 5 mg per meal 2 1 120 to 139.9 kg 265 – 308 lb 6 mg per meal - 2A 1 mg blister of EXUBERA inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected regular human insulin. A 3 mg blister of EXUBERA inhaled insulin is approximately equivalent to 8 IU of subcutaneously injected regular human insulin. Table 8 provides the approximate IU dose of regular subcutaneous human insulin for EXUBERA inhaled insulin doses from 1 mg to 6 mg.
Table 8: Approximate Equivalent IU Dose of Regular Human Subcutaneous Insulin for EXUBERA Inhaled Insulin Doses Ranging from 1 mg to 6 mg Dose (mg) Approximate Regular Insulin SC Dose in IU Number of 1 mg EXUBERA Blisters per Dose Number of 3 mg EXUBERA Blisters per Dose 1 mg 3 1 - 2 mg 6 2 - 3 mg 8 - 1 4 mg 11 1 1 5 mg 14 2 1 6 mg 16 - 2Patients should combine 1 mg and 3 mg blisters so that the least number of blisters per dose are taken (e.g., a 4 mg dose should be administered as one 1 mg blister and one 3 mg blister). Consecutive inhalation of three 1 mg unit dose blisters results in significantly greater insulin exposure than inhalation of one 3 mg unit dose blister. Therefore, three 1 mg doses should not be substituted for one 3 mg dose (see CLINICAL PHARMACOLOGY, Pharmacokinetics). When a patient is stabilized on a dosing regimen that includes 3 mg blisters, and the 3 mg blisters become temporarily unavailable, the patient can temporarily substitute two 1 mg blisters for one 3 mg blister. Blood glucose should be monitored closely.
As with all insulins, additional factors that should be taken into consideration when determining the EXUBERA starting dose include, but are not limited to, patient's current glycemic control, previous response to insulin, duration of diabetes, and dietary and exercise habits.
Considerations for Dose TitrationAfter initiating EXUBERA therapy, as with other glucose-lowering agents, dose adjustment may be required based on the patient's need (e.g., blood glucose concentrations, meal size and nutrient composition, time of day and recent or anticipated exercise). Each patient should be titrated to their optimal dosage based on blood glucose monitoring results.
As for all insulins, the time course of EXUBERA action may vary in different individuals or at different times in the same individual.
EXUBERA may be used during intercurrent respiratory illness (e.g., bronchitis, upper respiratory tract infection, rhinitis). Close monitoring of blood glucose concentrations and dose adjustment may be required on an individual basis. Inhaled medicinal products (e.g. bronchodilators) should be administered prior to administration of EXUBERA.
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