Generic name: insulin human (rDNA origin)
Dosage form: inhalation powder
Medically reviewed on April 9, 2018.
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 Dose
The 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:
|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||-||2|
A 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.
|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|
Patients 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 Titration
After 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.