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-actin g 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- actin g insulin. In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in combination with oral agents or longer-acting insulins.

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 agent s 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 p re-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)

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 m g.

Table 8: Approximate Equivalent IU Dose of Regular Human Subcutaneous Insulin for EXUBERA Inhaled Insulin Doses Ranging from 1 mg to 6 mg

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-lower in g 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.

EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available in 1 mg and 3 mg unit dose blisters. The blisters are dispensed on perforated cards of six unit dose blisters (PVC/Aluminum). The two strengths are differentiated by color print and tactile marks that can be differentiated by touch. The 1 mg blisters and respective perforated cards are printed with green ink and the cards are marked with one raised bar. The 3 mg blisters and respective perforated cards are printed with blue ink and the cards are marked with three raised bars.

Five blister cards are packaged in a clear plastic (PET) thermoformed tray. Each PET tray also contains a desiccant and is covered with a clear plastic (PET) lid. The tray of five blister cards (30 unit dose blisters) is sealed in a foil laminate pouch with a desiccant .

The EXUBERA® Inhaler consists of the inhaler base, a chamber, and an EXUBERA® Release Unit. A replacement chamber is available separately . EXUBERA® Release Units are individually packaged in a sealed thermoformed tray. EXUBERA® Release Units are available as part of a Patient Pack, the EXUBERA® CareKit, and as separate replacements.

See Tables 9 and 10 for a description of these configurations.

EXUBERA® (insulin human [rDNA origin] inhalation powder) Blisters, an EXUBERA® Inhaler, and replacement EXUBERA® Release Units are required to initiate therapy with EXUBERA.

Table 9: EXUB ERA® (insulin human [rDNA origin]) Inhalation Powder is available as follows

Table 10: EXUB ERA® Inhaler and Components are available as follows

Blister Storage:

Not in-use (Unopened): Store at controlled room temperature, 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate.

In-use: Once the foil overwrap is opened, unit dose blisters should be protected from moisture, stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate. Unit dose blisters should be used within 3 months after opening the foil overwrap. Return the blisters to the overwrap to protect from moisture. Additional care should be taken to avoid humid environments, e.g. steamy bathroom following a shower.

Discard blister if frozen.

Inhaler Storage

Store at controlled room temperature, 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Do not freeze. Do not refrigerate.

The EXUBERA® Inhaler can be used for up to 1 year from the date of first use.

Replacing The EXUBERA® Release Unit

The EXUBERA® Release Unit in the EXUBERA® Inhaler should be changed every 2 weeks.

Keep out of reach of children

January 2006. Distributed by : Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. FDA Rev date: 1/27/2006

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