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Exubera

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Exubera

Indications
Dosage
How Supplied

INDICATIONS

EXUBERA (insulin human [rdna origin]) is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. EXUBERA (insulin human [rdna origin]) 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 (insulin human [rdna origin]) should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, EXUBERA (insulin human [rdna origin]) can be used as monotherapy or in combination with oral agents or longer-acting insulins.

DOSAGE AND ADMINISTRATION

EXUBERA (insulin human [rdna origin]) , like rapid-acting insulin analogs, has a more rapid onset of glucose-lowering activity compared to subcutaneously injected regular human insulin. EXUBERA (insulin human [rdna origin]) has a duration of glucose-lowering activity comparable to subcutaneously injected regular human insulin and longer than rapid-acting insulin. EXUBERA (insulin human [rdna origin]) doses should be administered immediately prior to meals (no more than 10 minutes prior to each meal).

In patients with type 1 diabetes, EXUBERA (insulin human [rdna origin]) should be used in regimens that include a longer-acting insulin. For patients with type 2 diabetes, EXUBERA (insulin human [rdna origin]) may be used as monotherapy or in combination with oral agents or longer-acting insulin.

Because of the effect of EXUBERA (insulin human [rdna origin]) on pulmonary function, all patients should have pulmonary function assessed prior to initiating therapy with EXUBERA (insulin human [rdna origin]) . Periodic monitoring of pulmonary function is recommended for patients being treated with EXUBERA (see PRECAUTIONS, Pulmonary Function).

EXUBERA (insulin human [rdna origin]) is intended for administration by inhalation and must only be administered using the EXUBERA (insulin human [rdna origin]) ® Inhaler. Refer to the EXUBERA (insulin human [rdna origin]) Medication Guide for a description of the EXUBERA (insulin human [rdna origin]) ® Inhaler and for instructions on how to use the inhaler.

Calculation of Initial Pre-Meal EXUBERA (insulin human [rdna origin]) Dose

The initial dosage of EXUBERA (insulin human [rdna origin]) 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 (insulin human [rdna origin]) doses, based on patient body weight, are indicated in Table 7:

Table 7: Approximate Guidelines for Initial, Pre-Meal EXUBERA (insulin human [rdna origin]) Dose (based on patient body weight) Human EXUBERA (insulin human [rdna origin]) Inhaled Insulin Doses Ranging

Patient Weight (in kg) Patient Weight (in lb) Initial Dose (in lb) per meal Number of 1 mg per Dose Number of 3 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 (insulin human [rdna origin]) inhaled insulin is approximately equivalent to 3 IU of subcutaneously injected regular human insulin. A 3 mg blister of EXUBERA (insulin human [rdna origin]) inhaled insulin is approximately equivalent to 8 IU of subcutaneously injected regular human insulin. Table 8provides the approximate IU dose of regular subcutaneous human insulin for EXUBERA (insulin human [rdna origin]) inhaled insulin doses from 1 mg to 6 mg.

Table 8: Approximate Equivalent IU Dose of Regular Human Subcutaneous Insulin for EXUBERA (insulin human [rdna origin]) Inhaled Insulin Doses Ranging 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
1 mg 3 1 -
2 mg 6 2 -
3 mg 8 - 1
4 mg 11 1 1
5 mg 14 2 1
6 mg 16 - 2

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 insulinexposure than inhalation of one 3 mg unit dose blister. Therefore, three 1 mg doses should notbe 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 (insulin human [rdna origin]) 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 (insulin human [rdna origin]) 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 (insulin human [rdna origin]) action may vary in different individuals or at different times in the same individual.

EXUBERA (insulin human [rdna origin]) 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 (insulin human [rdna origin]) .

HOW SUPPLIED

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.

EXUBERA (insulin human [rDNA origin]) Inhalation Powder blisters, an EXUBERA (insulin human [rdna origin]) ® Inhaler, and replacement EXUBERA (insulin human [rdna origin]) ® Release Units are required to initiate therapy with EXUBERA (insulin human [rdna origin]) and are provided in the EXUBERA (insulin human [rdna origin]) Kit. A fully assembled EXUBERA (insulin human [rdna origin]) ® Inhaler consists of the inhaler base, a chamber, and an EXUBERA (insulin human [rdna origin]) ® Release Unit. A fully assembled Inhaler is packaged with a replacement Chamber and is available in the EXUBERA (insulin human [rdna origin]) Kit and as a separate unit. The Chamber is also available as an individual component.

EXUBERA (insulin human [rdna origin]) ® Release Units are individually packaged in a sealed thermoformed tray. One EXUBERA (insulin human [rdna origin]) ® Release Unit is included in each fully assembled Inhaler. Two additional Release Units are provided in the EXUBERA (insulin human [rdna origin]) Kit and in each Combination Pack. EXUBERA (insulin human [rdna origin]) Release Units are also available individually.

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

Table 9

EXUBERA (insulin human [rDNA origin]) Inhalation Powder is available as follows:
Description Contents NDC
EXUBERA KIT 1 EXUBERA (insulin human [rdna origin]) Inhaler
1 Replacement Chamber
1 mg × 180 blisters
3 mg × 90 blisters
2 EXUBERA (insulin human [rdna origin]) ® Release Units
0069-0050-85
EXUBERA Combination Pack 12 1 mg × 90 blisters
3 mg × 90 blisters
2 EXUBERA (insulin human [rdna origin]) ® Release Units
0069-0050-19
EXUBERA Combination Pack 15 1 mg × 180 blisters
3 mg × 90 blisters
2 EXUBERA (insulin human [rdna origin]) ® Release Units
0069-0050-53
EXUBERA 1 mg Patient Pack 90 × 1 mg
2 EXUBERA® Release Units
0069-0707-37
EXUBERA 3 mg Patient Pack 90 × 3 mg
2 EXUBERA® Release Units
0069-0724-37

Table 10

EXUBERA® Inhaler and Components are available as follows:
Description Contents NDC
EXUBERA® Inhaler & Chamber 1 EXUBERA® Inhaler
1 Replacement Chamber
0069-0054-19
EXUBERA® Release Units 2 EXUBERA® Release Units 0069-0097-41
EXUBERA® Chamber 1 Replacement Chamber 0069-0061-19

Blister Storage

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

The EXUBERA (insulin human [rdna origin]) ® Inhaler can be used for up to 1 year from the date of first use.

Replacing The EXUBERA (insulin human [rdna origin]) ® Release Unit

The EXUBERA (insulin human [rdna origin]) ® Release Unit in the EXUBERA (insulin human [rdna origin]) ® Inhaler should be changed every 2 weeks.

Keep out of reach of children

Distributed by: Pfizer Labs, Divisions of Pfizer Inc, NY, NY 10017. FDA Rev date: 9/29/2008

Last reviewed on RxList: 12/11/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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