Patient Device Request Form

MannKind is offering a program to support you and your patients by supplying FEV₁ devices directly to patients. As you are aware, the FEV₁ handheld device is one of the tools that can be used to help establish a baseline assessment and monitor lung function before initiating Afrezza® (insulin human) Inhalation Powder. Once Afrezza therapy has been initiated, a follow-up assessment should be conducted at 6 months and annually thereafter.

For any of your patients that need a FEV₁ test and are unable to come to your office, MannKind will directly mail a FEV₁ device to them. In addition to the device, we will provide a link to the manufacturer’s instructions on how to properly conduct the test. Once the test is completed, your patients can share their results with you.

Why is it necessary to provide this authorization?
In order for MannKind to provide your patients a FEV₁, we will need to receive, look at, use, and disclose patients’ personally identifiable information (“PII”), including certain health information of theirs. By signing this form, you are confirming that you have your patient’s authorization to transmit their PII to us and you are authorizing us to receive, use and further disclose it as necessary to assist your patient and communicate with them. Please understand that we cannot assist your patient and provide services without this authorization.

What information will be shared with MannKind?

• Name and contact information provided
• Any other information that you may voluntarily choose to provide

How will your patient’s information be used by MannKind?

• To provide your patient with a handheld FEV₁ device, which measures the movement of air in and out of the lungs, and a product demonstration kit, which includes an inhaler and empty cartridges

MannKind’s Commitment to You

• We do not, and will not sell, or rent you or your patient’s information to marketing companies or mailing list brokers
• We will only collect and use PII for the purposes stated in this Authorization
• We take seriously our obligation to comply with state and federal laws that protect personally identifiable information, and protected health information

Authorization to Contact

I understand and have obtained consent from my patient for MannKind to use the contact information provided in this form to directly mail a FEV₁ device to them. I understand that the operation and administration of these services may require that MannKind contact me or my patient by telephone or SMS/text and that the cell phone carrier’s standard rates may apply for calls or text messages to a cell phone.

MannKind-Provided FEV₁ Device
By requesting a handheld FEV₁ device for your patient, you agree that the purpose of providing your patient with these items is to allow you and your patient to assess the health of their lungs. You understand that MannKind is not a healthcare provider and that any interpretation of test results (FEV₁ or otherwise) or any decision to prescribe any treatment for a medical condition(s) must be made by you. Any provided medical equipment that was manufactured by a third party is provided as-is and MannKind makes no warranty with respect to such provided items, including its fitness for a particular purpose. The items provided to your patient by MannKind are for their personal use only and not for resale. You acknowledge that any medical equipment provided to your patient by MannKind is not being provided pursuant to schemes eligible for reimbursement and you hereby agree not to seek reimbursement for any items provided to your patient by MannKind from any third-party payer, including Medicaid, Medicare, commercial payers or any state or federal healthcare programs.

Healthcare Practitioner/Physician Information(*required information)

First Last

Primary Phone*

Primary Phone Type

Email*

Patient Name*

First Last

Primary Phone*

Primary Phone Type

Email*

Shipping Address:*

Street City State Zip

This Authorization may be signed electronically. If signing electronically, by typing your name in the signature section of this page, you agree that you are signing this document. You understand that your electronic signature is legally binding, just as if you signed a paper document, and you acknowledge that you have read and understand this FEV₁ Device Request Form.

By signing below, I am providing my consent and indicating my legal authorization for MannKind and its contractors and business partners to use and share the personal information I give only for the purposes described within this Authorization.

Signature of Healthcare Practitioner/Physician or authorized representative (type here)*

US-AFR-1332

What is AFREZZA?

AFREZZA is a man-made insulin that is breathed-in through your lungs (inhaled) and is used to control high blood sugar in adults with diabetes mellitus.

Important Safety Information

What is the most important information I should know about AFREZZA? AFREZZA can cause serious side effects, including:

Sudden lung problems (bronchospasms). In a study, some AFREZZA-treated patients with asthma, whose asthma medication was temporarily withheld, experienced sudden lung problems. Do not use AFREZZA if you have long-term (chronic) lung problems such as asthma or chronic obstructive pulmonary disease (COPD). Before starting AFREZZA, your healthcare provider will give you a breathing test to check how your lungs are working.

Important Safety Information(cont’d)

Who should not use Afrezza®?

Do not use Afrezza® if you:

Have chronic lung problems such as asthma or COPD.
Are allergic to regular human insulin or any of the ingredients in Afrezza®.
Are having an episode of low blood sugar (hypoglycemia).

What should I tell my healthcare provider before using Afrezza®?

Before using Afrezza®, tell your healthcare provider about all your medical conditions, including if you:

Have lung problems such as asthma or COPD
Have or have had lung cancer
Are using any inhaled medications
Smoke or have recently stopped smoking
Have kidney or liver problems
Are pregnant, planning to become pregnant, or are breastfeeding. Afrezza® may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements.

Before you start using Afrezza®, talk to your healthcare provider about low blood sugar and how to manage it.

What should I avoid while using Afrezza®?

While using Afrezza® do not:

Drive or operate heavy machinery, until you know how Afrezza® affects you.
Drink alcohol or use over-the-counter medicines that contain alcohol.
Smoke.

What are the possible side effects of Afrezza®?

Afrezza® may cause serious side effects that can lead to death, including:

See “What is the most important information I should know about Afrezza®?”

Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- Dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger.
Decreased lung function. Your healthcare provider should check how your lungs are working before you start using AFREZZA, 6 months after you start using it, and yearly after that.
Lung cancer. In studies of Afrezza® in people with diabetes, lung cancer occurred in a few more people who were taking Afrezza® than in people who were taking other diabetes medications. There were too few cases to know if lung cancer was related to Afrezza®. If you have lung cancer, you and your healthcare provider should decide if you should use Afrezza®.
Diabetic ketoacidosis. Talk to your healthcare provider if you have an illness. Your Afrezza® dose or how often you check your blood sugar may need to be changed.
Severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
- A rash over your whole body, trouble breathing, a fast heartbeat, or sweating.

Low potassium in your blood (hypokalemia).
Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Afrezza® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Afrezza®. Your healthcare provider should monitor you closely while you are taking TZDs with Afrezza®. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
- Shortness of breath, swelling of your ankles or feet, sudden weight gain.

Treatment with TZDs and Afrezza® may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

• Trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Afrezza® include:

Low blood sugar (hypoglycemia), cough, sore throat

These are not all the possible side effects of Afrezza®. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

Please See Full Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use for AFREZZA.

Medication Guide

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