Training Example: Kanuma (Alexion Pharmaceuticals) – Review the Data, Give Your Score & Compare to the Real AI Evaluation

[H1] The only FDA-Approved treatment for Lysosomal Acid Lipase Deficiency (LAL-D)

KANUMA® (sebelipase alfa) is a prescription medication used to treat people with a diagnosis of LAL-D.

[H1]
Kanuma®
(sebelipase alfa) is administered via infusion

KANUMA is indicated for the treatment of people with a diagnosis of LAL-D and is administered
as an infusion by a healthcare professional.

For more information on KANUMA infusions:

[H3]
Download Infusion Brochure

[H1] Getting Started on Kanuma

KANUMA is indicated for the treatment of patients with a diagnosis of LAL-D. Once your doctor has determined that KANUMA is right for you, sign up for OneSource™, a personalized patient support program from Alexion Pharmaceuticals.

There are 2 ways to get access to OneSource:

Call 1-888-765-4747

Get in touch with a OneSource Case Manager.

Download the OneSource enrollment form below

Print this form, sign it, and submit it to OneSource. Someone will be in touch within the next business day.

Submit via email:
OneSource@alexion.com

Submit via fax: 1-800-420-5150

[H3]
Download OneSource enrollment form

[H1]
KANUMA support by OneSource™

With our experience and resources, we’re here to help you feel
supported every step of the way. Here’s an overview of the services we
offer.

Education

When you have questions about LAL-D or KANUMA, we’ll work to find the answers.
At OneSource, your dedicated Case Manager can provide you with:

Educational materials to help you learn more about LAL-D
Details about KANUMA
Information about the treatment process

Health Insurance Navigation

Health insurance can be complicated. We’re here to help make sense of it all.
Your Case Manager can help by:

Providing information that explains your insurance coverage for KANUMA
Addressing financial concerns or gaps in coverage
Informing you of infusion centers or other treatment location options nearby

Community Connections

With OneSource by your side, you’ll never have to go it alone.
Connect with others in the rare disease community who understand your
experience. Your Case Manager can share information about:

In-person and online meetings and events specific to your condition
Support and resources
Advocacy groups
A peer-to-peer program called Peer Connects

Ongoing Support

When life takes a turn, OneSource is ready to keep you on track.
Your Case Manager is ready to help:

Guide you through insurance changes or finding new treatment locations
Navigate your treatment through life events, such as getting married,
starting a new job, moving, or traveling
Work with your healthcare provider and specialty pharmacy to ensure you
keep receiving your medicine as prescribed

[H3] CoPay Program

Here are some additional services we provide to help support you with KANUMA

Financial Assistance

We can provide information about resources available that may be able to help cover the costs for KANUMA.

If you have Medicare, Medicaid, or another federal- or state-funded
insurance plan, we can connect you to third-party resources that may be able
to help with financial assistance.

If you have commercial insurance, you may be eligible for the
Alexion OneSource CoPay Program,
which may be able to help cover some out-of-pocket treatment costs.

To be eligible for the CoPay Program, you must:

Be signed up for patient services through OneSource

Have commercial insurance (not part of a federal- or state-funded
healthcare program)

Be prescribed KANUMA for an FDA-approved indication

Reside in the United States or its territories

Talk to your healthcare provider or OneSource Case Manager for more information about financial assistance.

[H3] Get connected with your

[H3] OneSource

[H3] Case Manager

[H3] 1-888-765-4747

[H3] Monday through Friday,

[H3]
8:30 AM to
8:00 PM (ET) or visit the website at
www.alexiononesource.com

[H3]
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Show less

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[H3]

What is the most important information I should know about KANUMA® (sebelipase alfa)?
Life-threatening allergic (hypersensitivity) reactions, including anaphylaxis may occur in people who
receive enzyme replacement therapies (ERT), including KANUMA. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Seek immediate
medical care if you have any of these signs or symptoms that may be related to a severe allergic
reaction:

•   Rash such as hives; may also
include itching

•   Difficulty breathing,
shortness of breath,

tightness in the chest, and wheezing (noises

while breathing)

•   Dizziness or feeling faint

•   Tingling and swelling around
the mouth, in

your throat, or eyes

•   Fast heartbeat

•   Very low blood pressure

•   Sweating

•   Loss of consciousness

•   Flushing or temporary
reddening of the skin (usually on the face)

•   Agitation or
irritability

Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

[H3]

[H3] Allergy to Eggs or Egg Products

Tell your doctor if you have had a severe allergic reaction to eggs or egg products, as people with a known
history of egg allergies were excluded from clinical trials.
[H3] Common Side Effects

The most common side effects in people treated with KANUMA are:
Infants with rapidly progressive LAL Deficiency presenting
within the first 6 months of life (≥30%):
diarrhea, vomiting, fever, stuffy or runny nose, anemia, cough, swelling of the nose and throat, and hives.

Pediatric and adult patients with LAL Deficiency (≥8%):
headache, fever, sore throat, swelling of the nose and throat, weakness, constipation, and nausea.
These are not all the possible side effects of KANUMA. Call your healthcare provider for medical advice
about side effects.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or plan to
breastfeed.
Tell your doctor about all the medications you take, including prescription and over-the-counter drugs,
vitamins, and herbal supplements.
To report SUSPECTED SIDE EFFECTS, contact Alexion at 1-844-259-6783 or the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
[H3] INDICATION
What is KANUMA® (sebelipase alfa)?
KANUMA is a prescription medicine that is used to treat people with a diagnosis of lysosomal acid
lipase (LAL) deficiency. It is administered as an infusion under the supervision of a healthcare provider.

Please see full
Prescribing Information
for KANUMA (sebelipase alfa), including Boxed WARNING regarding
hypersensitivity reactions including anaphylaxis.

[H3]
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Show more

[IMG: Arrow]

[H3]

What is the most important information I should know about KANUMA® (sebelipase alfa)?
Life-threatening allergic (hypersensitivity) reactions, including anaphylaxis may occur in people who
receive enzyme replacement therapies (ERT), including KANUMA. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Seek immediate
medical care if you have any of these signs or symptoms that may be related to a severe allergic
reaction:

•   Rash such as hives; may also
include itching

•   Difficulty breathing,
shortness of breath,

tightness in the chest, and wheezing (noises

while breathing)

•   Dizziness or feeling faint

•   Tingling and swelling around
the mouth, in

your throat, or eyes

•   Fast heartbeat

•   Very low blood pressure

•   Sweating

•   Loss of consciousness

•   Flushing or temporary
reddening of the skin (usually on the face)

•   Agitation or
irritability

Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

[H3]

[H1] The only FDA-approved treatment for patients with Lysosomal Acid Lipase Deficiency (LAL-D)1,2

KANUMA® (sebelipase alfa) is a hydrolytic lysosomal cholesteryl ester and triacylglycerol–specific enzyme indicated for the treatment of patients with a diagnosis of LAL-D.1

[H1] Dosing

KANUMA is administered as an intravenous infusion under the supervision of a healthcare professional.1 For more information, download the full Prescribing Information and Dosing and Administration brochure below:

[H3] Download Full Prescribing Information

[H1] Getting Started on Kanuma® (sebelipase alfa)

KANUMA is approved by the U.S. Food and Drug Administration as a treatment for patients with a diagnosis of LAL-D.1
Once you have decided that KANUMA is right for your patient, here’s how OneSource™ can help you get your patients with LAL-D started on KANUMA:

Call the OneSource team at 1-888-765-4747 (Monday through Friday, 8:30 am to 8:00 pm [ET]). OneSource Customer Operations will work to facilitate order processing and delivery.

Ask your patient to sign the OneSource enrollment form to start working with a Case Manager.

[H3] Download ONESOURCE ENROLLMENT FORM

[H1]
We’re Here to Help

After your patient signs up, they will be matched with a dedicated OneSource
Case Manager who can help answer questions about KANUMA or
LAL-D. OneSource is staffed by Case Managers who provide
one-to-one education, assistance with funding options and access to KANUMA,
as well as ongoing treatment support for your patients living with LAL-D,
and their caregivers.

With our experience and resources, we’re here to help your patient and
their caregiver feel supported every step of the way. Here’s an
overview of the services we offer.

Education

When your patients or their caregivers have questions about LAL-D or KANUMA, we’ll work to find the answers.
Your patient's dedicated Case Manager can provide them with:

Educational materials to help your patient learn more about LAL-D
Details about KANUMA
Information about the treatment process

Health Insurance Navigation

Health insurance can be complicated. We’re here to help make sense of it all.
Your patient's Case Manager can help by:

Providing information that explains
your patient’s insurance coverage for KANUMA
Addressing financial concerns or gaps in coverage
Informing your patient of infusion centers or other treatment location
options nearby

Community Connections

With OneSource by your patient’s side, they’ll never have to go through it alone.
Connect with others in the rare disease community who understand your
patient’s experience. We can share information about:

In-person and online meetings and events specific to
your patient’s condition
Support and resources
Advocacy groups
A peer-to-peer program called Peer Connects

Ongoing Support

When life takes a turn, OneSource is ready to keep your patient on track.
Your patient's Case Manager is ready to help:

Guide your patient through insurance changes or finding new treatment
locations
Navigate your patient's treatment through life events, such as getting
married, starting a new job, moving, or traveling
Work with you and the patient's specialty pharmacy to ensure your
patient keeps receiving their medicine as prescribed

[H3] CoPay Program

Here are some additional services we provide to help support your patient
with KANUMA

Financial Assistance

We can provide information about resources available that may be able to help cover the costs for KANUMA.

If your patient has Medicare, Medicaid, or another federal- or
state-funded insurance plan, we can connect them to third-party resources
that may be able to help with financial assistance.

If your patient has commercial insurance, they may be eligible for the
Alexion OneSource CoPay Program,
which may be able to help cover some out-of-pocket treatment costs.

To be eligible for the CoPay Program, your patient must:

Be signed up for patient services through OneSource

Have commercial insurance (not part of a federal- or state-funded
healthcare program)

Be prescribed KANUMA for an FDA-approved indication

Reside in the United States or its territories

[H3] Help get your patient connected

[H3] with their OneSource

[H3] Case Manager

[H3] 1-888-765-4747

[H3] Monday through Friday,

[H3]
8:30 AM to 8:00 PM (ET) or visit
the website at
www.alexiononesource.com

Connect with Alexion:     Medical Information

[H3]
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Show less

[IMG: Arrow]

[H3]

[H3]

[H3]
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Initiate KANUMA in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue KANUMA and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1)].

[H3] WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis
Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with enzyme replacement therapies, including KANUMA. These reactions in KANUMA-treated patients were based on application of Sampson criteria to identify signs/symptoms consistent with anaphylaxis. In clinical trials, 3 (infants) of 106 (3%) patients treated with KANUMA experienced signs and symptoms consistent with anaphylaxis. These patients experienced reactions during infusion with signs and symptoms including chest discomfort, conjunctival injection, dyspnea, generalized and itchy rash, hyperemia, swelling of eyelids, rhinorrhea, severe respiratory distress, tachycardia, tachypnea, and urticaria.
In clinical trials, 21 of 106 (20%) KANUMA-treated patients, including 9 of 14 (64%) infants and 12 of 92 (13%) pediatric patients who were 4 years and older and adults, experienced signs and symptoms either consistent with or that may be related to a hypersensitivity reaction. Signs and symptoms of hypersensitivity reactions, occurring in two or more patients, included abdominal pain, agitation, fever, chills, diarrhea, eczema, edema, hypertension, irritability, laryngeal edema, nausea, pallor, pruritus, rash, and vomiting. Most reactions occurred during or within 4 hours of the completion of the infusion. Patients were not routinely pre-medicated prior to infusion of KANUMA in these clinical trials.
Administration of KANUMA should be supervised by a healthcare provider knowledgeable in the management of severe hypersensitivity reactions including anaphylaxis. Observe patients closely during and after the infusion.
The management of hypersensitivity reactions should be based on the severity of the reaction and may include temporarily interrupting the infusion, lowering the infusion rate, and/or treatment with antihistamines, antipyretics, and/or corticosteroids. If interrupted, the infusion may be resumed at a slower rate with increases as tolerated. Pre-treatment with antipyretics and/or antihistamines may prevent subsequent reactions in those cases where symptomatic treatment was required.
Consider the risks and benefits of re-administering KANUMA following a severe reaction. Monitor patients, with appropriate resuscitation measures available, if the decision is made to re-administer the product.
Hypersensitivity to Eggs or Egg Products
Patients with a known history of egg allergies were excluded from the clinical trials. Consider the risks and benefits of treatment with KANUMA in patients with known systemic hypersensitivity reactions to eggs or egg products.
[H3] ADVERSE REACTIONS

In clinical trials, the most common adverse reactions were:

Infants with Rapidly Progressive LAL Deficiency Presenting within the First 6 Months of Life (≥30%):
diarrhea, vomiting, fever, rhinitis, anemia, cough, nasopharyngitis, and urticaria.

Pediatric and Adult Patients with LAL Deficiency (≥8%): headache, fever, oropharyngeal pain, nasopharyngitis, asthenia, constipation, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Alexion
Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1- 800-FDA-1088
or
www.fda.gov/medwatch
[H3] INDICATION
KANUMA® (sebelipase alfa) is
indicated for the treatment of patients with a diagnosis of
Lysosomal Acid Lipase (LAL) deficiency.

Please see full
Prescribing Information
for KANUMA (sebelipase alfa), including Boxed WARNING regarding
hypersensitivity reactions including anaphylaxis.

Reference:  1. KANUMA Package Insert. Boston, MA: Alexion Pharmaceuticals, Inc. 2. US National Library of Medicine. DailyMed. Accessed January 11, 2022. https://dailymed.nlm.nih.gov/dailymed/advanced-search.cfm

[H3]
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Show more

[IMG: Arrow]

[H3]

[H3]

[H3]
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Initiate KANUMA in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue KANUMA and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1)].