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Spirometry Recommendations for Exubera® Patients
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You may have read or heard about a new form of insulin that is inhaled through the mouth into the lungs instead of injected. The availability of inhalable insulin is long-awaited news for people with diabetes. In January 2006 the FDA approved Pfizer’s Exubera®, the first inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. Because of the effect of Exubera® on pulmonary function, all patients should have spirometry assessed prior to initiating therapy.

The following is general information in regard to the recommended use of spirometry for Exubera® patient selection and follow up monitoring. Complete prescribing information can and should be obtained by contacting Pfizer, Inc.

Prior to initiating Exubera® therapy:

All patients should have spirometry assessed prior to initiating therapy. The efficacy and safety of patients with baseline FEV1 < 70% predicted have not been established and the use of Exubera® in this population is not recommended.

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® on this population 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 and hyperglycemia. Bronchodilators and other inhaled products may alter the absorption of Exubera®.

Exubera® is contraindicated in patients who smoke or who have smoked within 6 months.

Children and teenagers should not take Exubera® because it has not been tested in enough patients under 18 years of age.

After initiating Exubera® therapy:

Spirometry testing is also recommended after the first 6 months of therapy and annually thereafter for patients on Exubera®, even in the absence of pulmonary symptoms. In patients who have a decline of >= 20% in FEV1 from baseline, spirometry should be repeated. If the >= 20% decline from FEV1 baseline is confirmed, Exubera® should be discontinued. The presence of pulmonary symptoms and lesser declines in pulmonary function may require more frequent monitoring of pulmonary function and consideration of discontinuation of Exubera®.

For reimbursement information related to the spirometry screening of Exubera® patients, please refer to our Free Reimbursement Guide.

This information is not a substitute for medical advice and does not provide a complete summary of Exubera® or any inhaled insulin product or address all considerations in making treatment decisions regarding their use. Always refer to the complete product information provided by the manufacturer.

Exubera® is a registered trademark of Pfizer, Inc.

Jones Medical Instrument Company is not sponsored by nor has any affiliation with Pfizer, Inc. or the Exubera® trademark.

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