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.
EXUBERA is contraindicated in patients hypersensitive to EXUBERA or one of its excipients.EXUBERA is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting EXUBERA therapy.
If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see CLINICAL PHARMACOLOGY, Special Populations, Smoking).The safety and efficacy of EXUBERA in patients who smoke have not been established.EXUBERA is contraindicated in patients with unstable or poorly controlled lung disease, because of wide variations in lung function that could affect the absorption of EXUBERA and increase the risk of hypoglycemia or hyperglycemia.
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.