Exubera is a rapid-acting insulin indicated for the treatment of adults with diabetes mellitus for the control ofhyperglycemia. 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 who smoke or who have discontinued smoking less than 6 months prior tostarting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due tothe increased risk of hypoglycemia and an alternative treatment must be utilized.
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. 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.
Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA
In clinical trials, treatment with EXUBERA was associated with small, non-progressive mean declines in pulmonary function relative to comparator treatments. Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function tests (e.g., spirometry) assessed prior to initiative therapy with EXUBERA, after 6 months oftherapy, and annually thereafter, even in the absence of pulmonary symptoms.
The long-term safety and effectiveness of EXUBERA in pediatric patients have not been established
In clinical studies, respiratory adverse events included cough, which tended to occur within seconds to minutes after EXUBERA inhalation. The incidence of cough decreased with continued EXUBERA use. Other respiratory adverse eventsincluded dyspnea, pharyngitis, sputum increase, and epistaxis. Non-respiratory adverse events reported in EXUBERA-treated patients include: hypoglycemia, chest pain, and dry mouth.
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 post-marketing 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.
EXUBERA is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior tostarting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due tothe increased risk of hypoglycemia and an alternative treatment must be utilized.
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. 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.
Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA
In clinical trials, treatment with EXUBERA was associated with small, non-progressive mean declines in pulmonary function relative to comparator treatments. Because of the effect of EXUBERA on pulmonary function, all patients should have pulmonary function tests (e.g., spirometry) assessed prior to initiative therapy with EXUBERA, after 6 months oftherapy, and annually thereafter, even in the absence of pulmonary symptoms.
The long-term safety and effectiveness of EXUBERA in pediatric patients have not been established
In clinical studies, respiratory adverse events included cough, which tended to occur within seconds to minutes after EXUBERA inhalation. The incidence of cough decreased with continued EXUBERA use. Other respiratory adverse eventsincluded dyspnea, pharyngitis, sputum increase, and epistaxis. Non-respiratory adverse events reported in EXUBERA-treated patients include: hypoglycemia, chest pain, and dry mouth.
No comments:
Post a Comment