Learning LAB

Health Care Provider

Guide to EXUBERA

Table of contents
Welcome to EXUBERA ............................................................................. 1 EXUBERA: a profile ................................................................................ 3 Indications and usage...................................................................4 Contraindications......................................................................... 4 Some considerations .................................................................... 5 Prescribing EXUBERA ..............................................................................6 Baseline and follow-up lung function testing ....................................6 Initiating EXUBERA........................................................................8 Titrating EXUBERA ........................................................................10 Using EXUBERA.....................................................................................11 Teaching patients how to use EXUBERA .............................................11 Parts of the EXUBERA Inhaler ........................................................12 Using the EXUBERA Inhaler ...........................................................14 Cleaning and maintaining the EXUBERA Inhaler.........................................20 Overview of cleaning the base, chamber, and mouthpiece ..................20 Storage .....................................................................................21 Replacing the EXUBERA Release Unit...............................................22 Replacing the inhaler ..................................................................23 What your patients need to take EXUBERA.................................................24 Summary of key points to communicate to patients ....................................25 EXUBERA FAQs .....................................................................................26 Introduction ..............................................................................26 Pulmonary-related questions ........................................................27 The EXUBERA Inhaler and blisters ..................................................28 The EXUBERA Center ............................................................................29 Important safety information .................................................................33

2006 Pfizer Inc.

All rights reserved.

Welcome to

EXUBERA is the first inhaled insulin.

This guide presents essential information for health care providers.

It contains important information that will help ensure patients gain the maximum benefits from EXUBERA.

The full prescribing information for EXUBERA can be found in the back of this guide.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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EXUBERA: a profile

EXUBERA: a profile
What is EXUBERA? EXUBERA is human insulin powder for oral inhalation. It is a revolutionary treatment option that can help patients achieve their glycemic goals. When is EXUBERA taken? EXUBERA is a rapid-acting insulin for mealtime control. Your patients should take EXUBERA within 10 minutes before a meal. How is EXUBERA taken? Unlike other insulins, EXUBERA is administered via the lungs by oral inhalation, using a specially designed inhaler. How is EXUBERA supplied? EXUBERA is available in convenient 1-mg and 3-mg insulin blisters. The blisters are dispensed on a perforated card of 6 insulin blisters that patients can easily carry.

A 1-mg blister is approximately equivalent to 3 IU of subcutaneously injected

regular insulin

A 3-mg blister is approximately equivalent to 8 IU of subcutaneously injected

regular insulin

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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EXUBERA: a profile

Indications and usage

EXUBERA is a rapid-acting insulin indicated for the treatment of adult patients

with diabetes mellitus for the control of hyperglycemia

EXUBERA has an onset of action similar to rapid-acting insulin analogs and In patients with type 1 diabetes, EXUBERA should be used in regimens that
include a longer-acting insulin

has a duration of glucose-lowering activity comparable with subcutaneously administered regular insulin

In patients with type 2 diabetes, EXUBERA can be used as monotherapy or in

combination with oral agents or longer-acting insulins

Contraindications

EXUBERA is contraindicated in patients who smoke or who have discontinued

smoking less than 6 months prior to starting EXUBERA therapy
- If a patient starts or resumes smoking, EXUBERA must be discontinued

immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized. The safety and efficacy of EXUBERA in patients who smoke 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 or hyperglycemia its excipients

EXUBERA is contraindicated in patients hypersensitive to EXUBERA or one of

Some considerations

The use of EXUBERA is not recommended in patients with underlying lung

disease such as asthma or COPD because the safety and efficacy of EXUBERA in this population have not been established not been established

The long-term safety and effectiveness of EXUBERA in pediatric patients have EXUBERA should be given to a pregnant woman only if clearly needed Patients must have a lung function test before starting EXUBERA Key points to communicate to patients:
Patients must not smoke, even occasionally, while taking EXUBERA. If a patient starts or resumes smoking, they should discontinue EXUBERA immediately. EXUBERA is not recommended in patients with underlying lung disease. Ask patients to inform you if they have a history of lung disease.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

Prescribing EXUBERA
Baseline and follow-up lung function testing
Lung function tests are necessary to confirm patient suitability

All patients should have a baseline lung function examination

- Spirometry to measure FEV1 prior to initiating EXUBERA - Assessment of DLCO should be considered

EXUBERA is not recommended in

Patients with baseline FEV1 or DLCO <70% predicted Patients with underlying lung disease such as asthma or COPD because the
Assessment of pulmonary function (eg, spirometry) is recommended after 6 months of therapy and annually thereafter

efficacy and safety of EXUBERA in this population have not been established

In patients who have a decline of 20% in FEV1 from baseline, pulmonary If the 20% decline 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 EXUBERA can be used during intercurrent respiratory illness

function tests should be repeated even in the absence of pulmonary symptoms

Close monitoring of blood glucose, and dose adjustment, may be required

As with other insulins, EXUBERA dose may need adjustment when used with certain other medications

Key points to communicate to patients:

Patients should be informed that in clinical studies, treatment with EXUBERA was associated with small, nonprogressive mean declines in pulmonary function relative to comparator treatments. Before starting on EXUBERA, all patients should undergo a lung function examination. Follow-up measurement after 6 months is recommended, and annually thereafter even in the absence of pulmonary symptoms.

Initial prescription

Prescribing EXUBERA

The EXUBERA Kit

One EXUBERA Inhaler One replacement chamber Two replacement EXUBERA Release Units 1-mg x 180 and 3-mg x 90 EXUBERA blisters

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

Initiating EXUBERA
The initial premeal dose is based on patient weight Recommended initial premeal doses are based on clinical trials in which patients were requested to eat three meals per day. Initial premeal doses may be calculated using the following formula: [Body weight (kg) x 0.05 mg/kg = premeal dose (mg)] rounded down to the nearest whole milligram number (eg, 3.7 mg rounded down to 3 mg). As with all insulins, the initial dosage of EXUBERA should be individualized and determined based on the health care providers advice in accordance with the needs of the patient.

Prescribing EXUBERA

Body weight

Initial EXUBERA premeal dose

66-87 lb 88-132 lb 133-176 lb 177-220 lb 221-264 lb 265-308 lb

1 mg per meal 1 mg 1 mg
per meal

3 mg per meal 3 mg 1 mg per meal 3 mg 1 mg 1 mg per meal

EXUBERA should be taken within 10 minutes before the start of a meal

Only one blister can be loaded into the inhaler at a time. Once released, the insulin from one blister should be inhaled before loading the next blister.

3 mg 3 mg per meal

Combine blisters so the least number are used per dose

- Example: A 4-mg dose should be administered as one 3-mg blister and one 1-mg blister

EXUBERA blisters should only be used with the EXUBERA

Inhaler

Three 1-mg blisters should not be substituted for one 3-mg blister
1 mg = approximately 3 IU of subcutaneous (SC) insulin. 3 mg = approximately 8 IU of SC insulin.

1 mg

1 mg

1 mg

3 mg

Consecutive inhalation of three 1-mg insulin blisters results in significantly greater

insulin exposure than inhalation of one 3-mg insulin blister. Three 1-mg doses should not be substituted for one 3-mg dose
- If 3-mg blisters are unavailable, patients should temporarily substitute two 1-mg blisters for one 3-mg blister. Blood glucose should be monitored closely

Converting units to milligrams

Approximate SC regular insulin dose 3 IU 6 IU 8 IU 11 IU 14 IU 16 IU EXUBERA dose (mg) 1 mg 2 mg 3 mg 4 mg 5 mg 6 mg

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Titrating EXUBERA

Each patient should be titrated to their optimal dosage based on blood

glucose monitoring results
Recommended ADA goal*1 Prelunch test Predinner test Prebedtime test 90-130 mg/dL 90-130 mg/dL <180 mg/dL

Monitor/adjust to maximal effective dose to meet recommended goal

* Based on American Diabetes Association (ADA) Standards of Medical Care in Diabetes1; goals should be individualized. Based on ADA-recommended postprandial target level.1

Self-monitoring of preprandial glucose levels is an integral part of managing diabetes and should be performed 3 or more times daily.1

EXUBERA should be titrated based on the following individual patient factors:

blood glucose concentrations, meal size and nutrient composition, time of day, and recent or anticipated exercise

Key points to communicate to patients:

A dose may be made up of more than one blister, and may include blisters on both green-labeled (1-mg) and blue-labeled (3-mg) cards. The exact blister or combination of blisters should be used as instructed. Do NOT substitute three 1-mg blisters for one 3-mg blister. If 3-mg blisters are temporarily unavailable, use only two 1-mg blisters as a replacement. New 3-mg blisters should be obtained as soon as possible. Only one blister can be loaded into the inhaler at a time. Once released, the insulin from one blister should be inhaled before loading the next one.

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Using EXUBERA
Teaching patients how to use EXUBERA
To maximize the benefits of EXUBERA, patients will need to understand how to use and care for the EXUBERA Inhaler. Patients should also be instructed on other important aspects of diabetes self-management such as hypoglycemia prevention and treatment, self-monitoring of blood glucose, and meal planning. For your reference, the following sections provide a summary of the use, care, and storage of the inhaler and blisters. However, prior to discussions with your patients, you may find it helpful to first review the following patient training materials: Guide to Using Your EXUBERA Inhaler, Quick Reference Guide, and Demonstration Video for Patients. These are available from your health care representative.

If you require further materials or more information, please contact The EXUBERA Center toll-free at 1-800-EXUBERA (1-800-398-2372) or visit www.exubera.com
Please see page 29 for additional information on The EXUBERA Center.

Patient training materials

Using EXUBERA

Demonstration video/DVD

Instruction guide

Quick reference guide

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Parts of the EXUBERA Inhaler

Side view (open)
Mouthpiece (open position) Front view (closed)

Chamber

Inhaler (closed)

Using EXUBERA

EXUBERA Release Unit

Chamber Release Button (one on each side) Base Blue Handle

Bottom view

Black Pull Ring

Date of First Use Label

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Front view (open)

Back view (open)

Gray Button

EXUBERA Blister Slot

Blue Dot Blue Button

Blue Handle

Black Pull Ring

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Using the EXUBERA Inhaler

Please refer to the EXUBERA Medication Guide for complete details before teaching patients.

There are 4 key steps.

Step 1: Load blister

Hold the black pull ring at the bottom of the base. Use it to pull the base out of the chamber. Listen for a click. Make sure the bottom of the chamber is above the gray button

Hold the blister with the notch pointed toward the inhaler as shown. The printed side should be up. Make sure the pocket containing the insulin faces down Do not open the blister

Slide the blister into the slot above the blue handle. Push the blister into the slot as far as it will go Load only one blister into the slot at a time

Key points to communicate to patients:

To open completely, make sure the bottom of the chamber is above the gray button and listen for a click. Be sure the pocket on the blister containing the insulin faces down. Never load more than one blister at a time.

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Step 2: Apply pressure

Make sure the mouthpiece is closed.

Pull out the blue handle from the bottom as far as it will go.

Squeeze the handle firmly until it snaps shut. This will put pressure in the system

Key points to communicate to patients:

Make sure the mouthpiece is closed before applying pressure. Squeeze the handle firmly until it snaps shut.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Step 3: Release cloud

Hold the EXUBERA Inhaler upright with the blue button facing you. Make sure the mouthpiece is closed

Press the blue button until it clicks.

A cloud of EXUBERA should fill the chamber. Remember, once the cloud is in the chamber, do not delay inhaling your dose

Key points to communicate to patients:

When EXUBERA is released, it will form a cloud in the chamber. Once the cloud is in the chamber, patients should not delay inhaling their dose.

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Step 4: Inhale
Stand or sit up straight. Then breathe out normally. Turn the mouthpiece around. Make sure the mouthpiece is facing you A small amount of EXUBERA may escape through the mouthpiece

Promptly place the mouthpiece fully in your mouth and form a seal around the mouthpiece with your lips. Do not blow into it

In one breath, slowly and deeply breathe the insulin cloud in through your mouth. Take the mouthpiece out of your mouth. Close your mouth and hold your breath for 5 seconds. Then breathe out normally. Some residue may remain in the chamber.

Key points to communicate to patients:

Patients should breathe in slowly and stay upright. The contents of only one blister should be inhaled at a time. Once released, the insulin from one blister should be inhaled before loading the next one. Remind patientsif their dose consists of more than one blister, they need to repeat Steps 1 through 4 immediately.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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After taking your blister

Turn the mouthpiece back to its closed position.

Press the gray button above the handle.

Pull out the used blister. Some residue may remain in the blister. Place it in the household trash, secured from children and pets.

If you need to use more than one blister for your dose, repeat Steps 1 through 4.
Remember: load and inhale only one blister at a time

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After taking your full dose

When you finish, close your inhaler. Squeeze the chamber release buttons located on both sides of the base at the same time

Push the base back into the chamber.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Cleaning and maintaining the EXUBERA Inhaler

Detailed instructions for cleaning and maintaining the inhaler can be found in the patient Guide to Using Your EXUBERA Inhaler and EXUBERA Medication Guide.

Overview of cleaning the base, chamber, and mouthpiece

Keeping the inhaler clean is very important to prevent medicine buildup and to help ensure the correct dose is obtained. The base, chamber, and mouthpiece will need to be cleaned at least once a week. The base should be cleaned with a clean, soft cloth dampened with water, and no soap. The chamber and mouthpiece should be cleaned using mild liquid soap and a soft cloth.

Cleaning the base

Cleaning the chamber and mouthpiece

Key points to communicate to patients:

No parts of the device should ever be placed in a dishwasher. The base should be kept away from water at all times. It is recommended that patients choose one day of the week (such as Monday) and clean the base, chamber, and mouthpiece after their last dose for that day every week. Remind patients to refer to the patient guide for detailed instructions.

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Storage
The EXUBERA Inhaler, EXUBERA Release Units, and EXUBERA blisters should be stored at room temperature (59F to 86F). Unopened blisters should be stored in their foil overwrap. Keep the blisters in their foil overwrap to help protect them from moisture. Blisters should be used within 3 months after opening the foil overwrap. The inhaler and blisters should be stored in a dry place, free from excess humidity. A bathroom cabinet, for example, is not a suitable place.

86 59

Key points to communicate to patients:

EXUBERA blisters and the inhaler should not be put in a refrigerator or freezer, nor stored in cold environments. They should also not be stored in humid environments, such as in the bathroom. Storing the inhaler in humid environments may decrease the dose delivered. If the inhaler is exposed to humidity, the release unit should be replaced prior to the next inhalation.

Cleaning and maintaining

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Replacing the EXUBERA Release Unit

The release unit is the part of the EXUBERA Inhaler that punctures the EXUBERA blister. It is situated at the top of the base. The release unit must be changed every 2 weeks. To replace it, first separate the chamber from the base.

1
Remove the old release unit. Turn the top of the release unit left, toward the unlock symbol on the base Pull the used unit out of the base. Place it in the household trash, secured from children and pets.

2
Hold the new release unit so the top is facing you. Turn the top of the new release unit all the way to the left. The small gray marks on the side should line up.

3
Line up the blue line on top of the unit with the unlock symbol. Gently insert the new unit into the top of the base.

4
Turn the top of the unit to the right as far as it will go, toward the lock symbol. The new unit should now fit tightly into the base When finished, the blue line should line up with the lock symbol

Cleaning and maintaining

Key points to communicate to patients:

The release unit must be changed every 2 weeks to help ensure the right dose is obtained. Patients can mark the release unit carton in the spaces provided to remind them when to replace the release unit.

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Replacing the inhaler

The inhaler needs to be replaced annually from the date of first use. Remind patients to write the date of first use on the label provided at the bottom of their inhaler as soon as they receive it.

Date of First Use Label

Key points to communicate to patients:

When patients first use the inhaler, they should write the date on the label on the bottom of the inhaler in permanent marker. The inhaler needs to be replaced annually from the date of first use.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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What your patients need to take EXUBERA

EXUBERA packaging is designed for ease of initiation

Be sure patients have their EXUBERA Kit when starting EXUBERA

The EXUBERA Kit contains:

One EXUBERA Inhaler (contains one EXUBERA One replacement chamber Two replacement release units 1-mg x 180 and 3-mg x 90 EXUBERA blisters

Release Unit)

EXUBERA components are available as follows:

Description EXUBERA Kit Contents 1 EXUBERA Inhaler 1 replacement EXUBERA Chamber 2 replacement EXUBERA Release Units 1-mg and 3-mg EXUBERA blisters 1 EXUBERA Inhaler + 1 replacement EXUBERA Chamber 2 EXUBERA Release Units 1 replacement EXUBERA Chamber Boxes of 1-mg and 3-mg EXUBERA blisters packaged with 2 EXUBERA Release Units

EXUBERA Inhaler EXUBERA Release Unit EXUBERA Chamber EXUBERA blisters

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Summary of key points

Summary of key points to communicate to patients

Starting EXUBERA

You must not smoke, even occasionally, while taking EXUBERA. If you start
smoking, I must take you off EXUBERA immediately

You need to have a lung function evaluation prior to initiating EXUBERA, and
have follow-up evaluations thereafter

Dosing

Never substitute three 1-mg blisters for one 3-mg blister. If 3-mg blisters are Load only one blister into the inhaler at a time. Once EXUBERA is released
into the chamber, you should inhale the insulin from one blister before you load the next one

unavailable, you should temporarily use two 1-mg blisters as a replacement

Maintenance and storage

Be sure to replace your release unit once every 2 weeks Do not refrigerate your inhaler or blisters. Also remember not to store them
in cold or humid areas

Your inhaler should be replaced each year. Make sure you label the date of
first use on the bottom of your device

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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EXUBERA FAQs

EXUBERA FAQs
Introduction
For whom is EXUBERA indicated?
EXUBERA is indicated for the treatment of adult patients (aged 18 years or older) with diabetes mellitus for the control of hyperglycemia.

Who must not take EXUBERA?

Patients who smoke or who have quit smoking within the past 6 months, and patients who have unstable or poorly controlled lung disease. Also, patients hypersensitive to EXUBERA or one of its excipients should not take EXUBERA.

How does the EXUBERA onset and duration of action compare with other insulins?
EXUBERA 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.

What diabetes regimens can include EXUBERA?

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.

Why is EXUBERA contraindicated in smokers?

In smokers, the systemic insulin exposure for EXUBERA is expected to be 2- to 5-fold higher than in nonsmokers, which may increase the risk of hypoglycemia.

What if a patient resumes smoking while on EXUBERA?

If a patient resumes smoking, EXUBERA must be discontinued immediately and an alternative treatment utilized.

Can secondhand smoke affect absorption of EXUBERA?

In contrast to the increase in insulin exposure following active smoking, when EXUBERA was administered to 30 healthy nonsmoking volunteers following 2 hours of exposure to passive cigarette smoke in a controlled experimental setting, insulin AUC and Cmax were reduced by approximately 20% and 30%, respectively. The pharmacokinetics of EXUBERA have not been studied in nonsmokers who are chronically exposed to passive cigarette smoke.

Can EXUBERA be used during pregnancy?

EXUBERA is classed in Pregnancy Category C. EXUBERA should be given to pregnant women only if clearly needed.

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Can nursing mothers take EXUBERA?

Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when EXUBERA is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in EXUBERA dose, meal plan, or both.

What are the most common adverse events of EXUBERA?

Hypoglycemia is the most commonly reported adverse event of insulin therapy, including EXUBERA. In clinical trials, cough was the most commonly reported respiratory adverse event. Patients who completed a cough questionnaire reported that cough tended to occur within seconds to minutes after inhalation, was predominantly mild in severity, and was rarely productive in nature.

EXUBERA FAQs

Pulmonary-related questions
What testing is required to confirm patient suitability prior to initiation?
All patients should have spirometry (FEV1) assessed prior to initiating therapy with EXUBERA. Assessment of DLco should be considered. The use of EXUBERA is not recommended in patients with baseline FEV1 or DLco <70% predicted. Periodic monitoring of pulmonary function is recommended for patients being treated with EXUBERA.

When should patients have a follow-up spirometry test?

Assessment of pulmonary function (eg, spirometry) is recommended after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms. In patients who have a decline of 20% in FEV1 from baseline, pulmonary function tests should be repeated. If the 20% decline from baseline FEV1 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.

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Will my patients develop a cough?

In clinical studies, cough was one of the most common respiratory adverse events. Patients who completed a cough questionnaire reported that the cough tended to occur within seconds to minutes after EXUBERA inhalation, was predominantly mild in severity, and was rarely productive in nature. The incidence of this cough decreased with continued EXUBERA use. In controlled clinical studies, 1.2% of patients discontinued EXUBERA treatment due to cough.

Can EXUBERA be used during intercurrent respiratory disease?

EXUBERA has been administered to patients with intercurrent respiratory illness (eg, bronchitis, upper respiratory tract infections, rhinitis) during clinical studies. During intercurrent respiratory illness, close monitoring of blood glucose concentrations and dose adjustment may be required. In patients with intercurrent respiratory disease, there was no increased risk of hypoglycemia or worsened glycemic control observed in EXUBERA-treated patients compared to patients treated with subcutaneous insulin.

EXUBERA FAQs

The EXUBERA Inhaler and blisters

Is it normal for residue to remain in the chamber after inhalation?
Yes, it is normal for some residue to remain in the chamber. The device is designed to ensure patients get the dose prescribed, so the residue does not interfere with proper dosing. It is important to clean the chamber every week.

Is it normal for residue to remain in the blister?

Yes, it is normal for some residue to remain in the blister.

What will happen if patients do not change the EXUBERA Release Unit?
Over time, medicine may build up on the release unit, which could affect its ability to puncture the blister. If the blister is not punctured properly, patients may not receive their full dose.

What will happen if patients do not clean their inhalers?

Patients need to clean the chamber and mouthpiece to prevent medicine buildup that may affect their dose.

Is it normal for some insulin to escape from the mouthpiece?

Yes, it is normal for some insulin to escape from the mouthpiece. When this happens, patients will still get the dose they need.

How do patients dispose of their used EXUBERA blisters, release units, and inhalers?
Patients should place their used EXUBERA blisters, release units, and inhalers in the household trash, secured from children and pets.

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The EXUBERA Center

If you think EXUBERA is right for your patients, were here with the information and support you and your patients might need. The customer care team at The EXUBERA Center can help answer questions about EXUBERA. Theyll even be able to assist your patients if something should happen to their EXUBERA Inhaler. Patients can also sign up to receive more information and updates to help keep them on the right track. To contact The EXUBERA Center, call 1-800-EXUBERA (1-800-398-2372) or visit www.exubera.com

The EXUBERA Center

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Notes

Notes

31

Please see important safety information on page 33, accompanying full prescribing information, and the EXUBERA Medication Guide.

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Important safety information

EXUBERA (insulin human [rDNA origin]) Inhalation Powder is a rapid-acting insulin indicated for the treatment of adults with diabetes mellitus for the control of hyperglycemia. 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 to starting EXUBERA therapy. If a patient starts or resumes smoking, EXUBERA must be discontinued immediately due to the 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, nonprogressive 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 (eg, spirometry) assessed prior to initiating therapy with EXUBERA, after 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms. 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 events included dyspnea, pharyngitis, and epistaxis. Nonrespiratory adverse events reported in EXUBERA-treated patients include, but are not limited to the following: hypoglycemia, chest pain, and dry mouth.

Important safety information

Reference: 1. American Diabetes Association. Standards of medical care in diabetes2006. Diabetes Care. 2006;29(suppl 1):S4-S42.

Please see accompanying full prescribing information and the EXUBERA Medication Guide.

Four key steps to using the EXUBERA Inhaler

Overview of patient instructions*

Load blister into the slot

Apply pressure by squeezing the handle shut

Release cloud into the chamber

Inhale EXUBERA

*Please see Using the EXUBERA Inhaler starting on page 14 of this guide.

Learning LAB
NN269227A 2006 Pfizer Inc. All rights reserved. Printed in USA/May 2006 U.S. Pharmaceuticals