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

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:

Download Full Prescribing Information

Download Dosing And Administration Brochure

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.

Download ONESOURCE ENROLLMENT FORM

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

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

Help get your patient connected

with their OneSource

Case Manager

1-888-765-4747

Monday through Friday,

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

Connect with Alexion: Medical Information

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.

Initiate the first dose of 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, as needed. [see Warnings and Precautions (5.1)]

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis

Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in KANUMA-treated patients, 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. Anaphylaxis has occurred as early as the sixth infusion and as late as 1 year after treatment initiation.

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. The majority of 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.

Due to the potential for anaphylaxis, administer the first dose of KANUMA in a healthcare setting with appropriate medical support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction occurs, immediately discontinue the infusion, and initiate appropriate medical treatment, including us of epinephrine, as needed. Observe patients closely during and after the infusion. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

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.

ADVERSE REACTIONS

The most common adverse reactions are:

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

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.

References: 1. KANUMA Package Insert. Boston, MA: Alexion Pharmaceuticals, Inc. 2021. 2. US National Library of Medicine. DailyMed. Accessed January 11, 2022.
https://dailymed.nlm.nih.gov/dailymed/advanced-search.cfm

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Hypersensitivity reactions, including anaphylaxis, have been reported in KANUMA-treated patients, based on application of Sampson criteria to identify signs/symptoms consistent with anaphylaxis...

Please see full Prescribing Information for KANUMA.

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

Dosing

Download Full Prescribing Information

Download Dosing And Administration Brochure

Getting Started on Kanuma® (sebelipase alfa)

Download ONESOURCE ENROLLMENT FORM

We’re Here to Help

CoPay Program

Help get your patient connected

with their OneSource

Case Manager

1-888-765-4747

Monday through Friday,

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

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

INDICATION

Welcome to KANUMA® (sebelipase alfa)

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Kanuma® (sebelipase alfa)

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Alexion Medical Information

THANK YOU

for your interest in learning more about a treatment for Lysosomal Acid Lipase Deficiency (LAL-D).

THANK YOU

for your inquiry about KANUMA™ (sebelipase alfa):

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

Getting Started on Kanuma^® (sebelipase alfa)

Welcome to KANUMA^® (sebelipase alfa)

Kanuma^® (sebelipase alfa)