Enrollment in the Myalept ByMySide Support Programmyaleptpro.com/sites/default/files/mya_starter_kit_documents_2018… · Fax the completed and signed forms to 1-877-328-9682 PRESCRIBING

©2018 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. MYA/US/155 03-18

To help doctors/healthcare providers and patients add Myalept to their current treatment plan, we offer a personalized support program called ByMySide. ByMySide helps provide the support services and resources patients need. When your patients sign up for the ByMySide program, they can access these support services at no cost:

• Help facilitate insurance and financial assistance process (if eligible)• Nutrition and dietitian services

• Specialty pharmacy services• Nurse education sessions

Steps for Healthcare Providers All prescribers of Myalept must be certified in the Myalept REMS Program prior to prescribing Myalept.

Steps for Your Patients

SupportAccessResources

Enrollment in the Myalept ByMySide Support Program

Please see the accompanying full Prescribing Information including Boxed Warning.

Additional copies of all forms can be downloaded from www.myaleptrems.com

QUESTIONS?

To speak with a ByMySide Coordinator, call 1-855-6MYALEPT (1-855-669-2537),

Monday-Friday, 8am-8pm ET

Review the enclosed Myalept Prescribing Information and Important Safety Information

Complete the Myalept REMS Program Prescriber Training Module at myaleptrems.com.

Complete, sign, and fax the enclosed Myalept REMS Program Prescriber Enrollment Form to 1-877-328-9682. Your REMS ID number will be e-mailed to you.

These highlights do not include all the information needed to use MYALEPT safely and effectively. See full prescribing information for MYALEPT.

MYALEPT® (metreleptin) for injection for subcutaneous use

Initial U.S. Approval: 2014

WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA

See full prescribing information for complete boxed warning.

Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences are not well characterized but could include inhibition of endo-genous leptin action and loss of MYALEPT efficacy. Worsening metabolic control and/or severe infection have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients with severe infections or loss of efficacy during MYALEPT treatment. Contact Aegerion Pharmaceuticals, Inc. at 1-866-216-1526 for neutralizing antibody testing. (4.1, 5.1)

T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT in patients with significant hematologic abnor-malities and/or acquired generalized lipodystrophy. (5.2)

MYALEPT is available only through a restricted program called the MYALEPT REMS PROGRAM. (5.3)

- - - - - - - - - - - - - - - INDICATIONS AND USAGE - - - - - - - - - - - - - -MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. (1)

Limitations of Use

• The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. (1)

• The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established. (1)

• MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. (1)

• MYALEPT is not indicated for use in patients with metabolic disease,without concurrent evidence of generalized lipodystrophy. (1)

- - - - - - - - - - - - - DOSAGE AND ADMINISTRATION - - - - - - - - - - - - Administer as a subcutaneous injection once daily after the lyophilizedcake is reconstituted with Bacteriostatic Water for Injection (BWFI) or preservative-free sterile Water for Injection (WFI). (2.1)

The recommended daily dosages are:

• Body weight 40 kg or less: starting dose 0.06 mg/kg/day, increase or decrease by 0.02 mg/kg to a maximum daily dose of 0.13 mg/kg. (2.1)

• Males greater than 40 kg body weight: starting dose 2.5 mg/day, increase or decrease by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day. (2.1)

• Females greater than 40 kg body weight: starting dose 5 mg/day, increase or decrease by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day. (2.1)

- - - - - - - - - - - - DOSAGE FORMS AND STRENGTHS - - - - - - - - - - -MYALEPT is supplied as a sterile, white, solid, lyophilized cake of 11.3 mg metreleptin per vial to deliver 5 mg per mL when reconstituted in 2.2 mL of BWFI or WFI. (3)

- - - - - - - - - - - - - - - - -CONTRAINDICATIONS - - - - - - - - - - - - - - - -• General obesity not associated with congenital leptin deficiency. (4.1)

• Hypersensitivity to metreleptin. (4.2)

- - - - - - - - - - - - - WARNINGS AND PRECAUTIONS - - - - - - - - - - - -• Anti-metreleptin antibodies with neutralizing activity: Could inhibit

endogenous leptin action and/or result in loss of MYALEPT efficacy. Test for neutralizing antibodies in patients with severe infections or loss of efficacy during MYALEPT treatment. (5.1)

• T-cell lymphoma: Carefully consider benefits and risks of treatment with MYALEPT in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy. (5.2)

• Hypoglycemia: A dose adjustment, including possible large reductions, of insulin or insulin secretagogue may be necessary. Closely monitor blood glucose in patients on concomitant insulin or insulin secretagogue therapy. (5.4)

• Autoimmunity: Autoimmune disorder progression has been observed in patients treated with MYALEPT. Carefully consider benefits and risks of MYALEPT treatment in patients with autoimmune disease. (5.5)

• Hypersensitivity: Hypersensitivity reactions (e.g., anaphylaxis, urticaria or generalized rash) have been reported. Patient should promptly seek medical advice regarding suspected reactions. (5.6)

• Benzyl Alcohol Toxicity: Preservative-free sterile WFI recommended for neonates and infants. (5.7)

- - - - - - - - - - - - - - - - -ADVERSE REACTIONS - - - - - - - - - - - - - - - -Most common in clinical trials (≥10%): headache, hypoglycemia, decreased weight, abdominal pain. (5.4, 6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aegerion Pharmaceuticals, Inc. at 1-855-303-2347 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

- - - - - - - - - - - - - USE IN SPECIFIC POPULATIONS - - - - - - - - - - - -• Pregnancy: MYALEPT should be used during pregnancy only if the

potential benefit justifies the potential risk to the fetus. No adequate and well-controlled studies have been conducted with metreleptin in pregnant women. (8.1)

• Nursing Mothers: Discontinue drug or nursing. (8.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 09/2015

WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA1 INDICATIONS AND USAGE

1.1 Patients with Generalized Lipodystrophy

2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosing

2.2 MYALEPT Preparation and Storage

2.3 Administration Instructions

2.4 Dosage Adjustments of Medications Known to Cause Hypoglycemia

2.5 Discontinuation in Patients at Risk for Pancreatitis

3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS

4.1 General Obesity

4.2 Hypersensitivity

5 WARNINGS AND PRECAUTIONS5.1 Risk for Development of Antibodies

that Neutralize Endogenous Leptin and/or MYALEPT

5.2 Lymphoma

5.3 MYALEPT REMS Program

5.4 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues

5.5 Autoimmunity

5.6 Hypersensitivity

5.7 Benzyl Alcohol Toxicity

6 ADVERSE REACTIONS6.1 Clinical Trials Experience

6.2 Immunogenicity

7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis,

Impairment of Fertility

14 CLINICAL STUDIES14.1 Open-Label, Single-Arm Study

16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION.

HIGHLIGHTS OF PRESCRIBING INFORMATION

FULL PRESCRIBING INFORMATION: CONTENTS*

* Sections or subsections omitted from the full prescribing information are not listed.

11.3 mg per vial

©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. MYA/US/135 12-17 Pg 1 of 1

MYALEPT® REMS ProgramPrescriber Enrollment Form

MYALEPT will be available only through the MYALEPT REMS Program. To prescribe MYALEPT, a prescriber must: (1) review the Prescribing Information, review and complete the Prescriber Training Module, (2) complete this one-time MYALEPT REMS Program Prescriber Enrollment Form, and (3) complete and submit a MYALEPT REMS Prescription Authorization Form for each new prescription.

Complete this enrollment form and fax it to the MYALEPT REMS Program at 1-877-328-9682.

Prescriber Information (Please Print *indicates a required field.)

Full Name (first, middle, last)*

Credentials* MD DO NP PA Other (specify)_____________________________________________________________

Physician Specialty* Endocrinology Family Medicine Cardiology General Internal Medicine Pediatrics Other_______________________________________

Who do you treat? Adults Pediatrics Both

Practice / Facility Name

Address 1*

Address 2 (optional) City* State* ZIP code*

Phone number* Alternate phone number* Fax number*

Email* NPI #*

Practice Setting* Solo private practice Group private practice Academic/Hospital affiliated practice Government Institution Other __________________________________________________________

Office Contact


Phone number (if different from above) Fax number (if different from above) Email (if different from above)

If you have any questions, please contact the MYALEPT REMS Program.Phone number: 1-855-669-2537 | Fax number: 1-877-328-9682 | www.MYALEPTREMS.com

Prescriber Attestations:

• I understand that MYALEPT is indicated as an adjunct to diet as replacement therapy to treat the complicationsof leptin-deficiency in patients with congenital or acquired generalized lipodystrophy.

• I affirm that my patient has a clinical diagnosis consistent with generalized lipodystrophy, and that my patient(or their caregiver) has been properly informed of the benefits and risks of MYALEPT therapy.

• I understand that MYALEPT is not indicated for:o the treatment of complications of partial lipodystrophy.o for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH).o for use in patients with HIV-related lipodystrophy.o for use in patients with metabolic disease including diabetes mellitus and hypertriglyceridemia without

concurrent evidence of congenital or acquired generalized lipodystrophy.• I understand that MYALEPT is contraindicated in patients with general obesity not associated with congenital

leptin deficiency.• I understand that MYALEPT is associated with serious adverse events due to the development of anti-metreleptin

antibodies that neutralize endogenous leptin and/or MYALEPT.• I agree to test for neutralizing antibodies in patients who experience severe infections or if I suspect MYALEPT is

no longer working (e.g., loss of glycemic control, or increases in triglycerides).• I understand that MYALEPT is associated with a risk of lymphoma.• I understand I must carefully consider the risks of treatment with MYALEPT in patients with significant

hematological abnormalities and/or acquired generalized lipodystrophy.

Signature* ______________________________________________________________ Date*____________________________

CERTIFICATION CHECKLIST

If you are already certified you may skip to the prescribing section.

Complete and sign the enclosed Myalept REMS Prescription Authorization Form. Please be sure to fill out all sections of the form. Incomplete areas may delay the start of treatment.

Complete and sign the enclosed ByMySide Enrollment Form to provide your patient access to comprehensive services including insurance coverage information, financial assistance (if eligible), injection training, fulfillment support, nutrition and dietician services, and adherence support.

Fax the completed and signed forms to 1-877-328-9682

PRESCRIBING CHECKLIST

MYALEPT® REMS ProgramPrescription Authorization Form

Instructions: Complete both pages of this form for each new prescription. All fields are required. Please Print.Please FAX completed form to MYALEPT REMS Program at 1-877-328-9682.The prescription for MYALEPT is only valid if received by fax. For New York prescribers: In addition to this completed form, provide New York specific prescription blanks.

Patient Information

Full Name (first, middle, last) Gender Male Female Date of Birth

Address City State ZIP code

Preferred phone number Alternate phone number Preferred time to contact: (check one) Day Evening

Email Alternate contact/phone #

Parent/Guardian (if applicable)

Insurance Information – Please copy and attach the front and back of the insurance card.

Insurance company phone number

Insured Name Relationship to patient

Insured Employer

Prescription card Yes No If yes, carrier_____________________________________________________________

Policy Number

Is the patient eligible for Medicare? Yes No

Policy number Group Number

Shipping Information

Full Name (first, middle, last)

Address (if different from above) City State ZIP code

Send initial shipment to prescribing doctor’s office Yes No

Prescriber Information


Practice/Facility Name Office Contact Person

Address 1

Address 2 City State Zip Code

Office Phone number Office Fax number License # NPI #


©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. BMS/US/005 10-17 Pg 4 of 5


Enrollment Form

HEALTHCARE PROVIDER: Please complete all sections of this form and fax to 1-877-328-9682.

I. PATIENT INFORMATION

Patient is (choose one): New Currently Receiving Myalept

Patient Name (First MI Last): ________________________________________________________________________________________

Address: _______________________________________________ City: ___________________ State: _____ Zip: ___________

Date of Birth: _____ /_____ / _____ Gender: Male Female Email: ________________________________________________

Primary Contact: Patient Legal Representative (if applicable): ________________________________________________________

Preferred Phone: _____________________ OK to leave message Alternate Phone: ____________________ OK to leave message

II. INSURANCE INFORMATIONPlease send a copy of the front and back of the medical and pharmacy insurance cards. If not available, please complete the fields below.Medical Insurance Prescription Insurance

Policy Holder Name: ______________________________________ Policy Holder Name: ____________________________________

Medical Insurance Phone: __________________________________ Prescription Insurance Phone: _____________________________

Medical Policy #: _________________Group # ________________ Prescription Policy #: ______________ Group # _____________

IV. PRESCRIBER INFORMATION

Prescriber Name: ________________________________________ Office Contact Name: ___________________________________

Prescriber Specialty: ______________________________________ Office Contact Phone: ___________________________________

Phone: ______________________ Fax: _______________________ Office Contact Email: ____________________________________

NPI #: _______________________ Lic #: ______________________ Tax ID #: ______________________________________________

REVIEW AND SIGN THE ACKNOWLEDGMENT AND AUTHORIZATION

I acknowledge that I have obtained any required authorization or other permission necessary to release the patient’s protected health infor-mation and the information on this form and any prescription to Aegerion Pharmaceuticals, its affiliates and their representatives, agents, and contractors (“Aegerion”), for the purposes of providing product support services, including but not limited to conveying personal information to dispensing pharmacies. I further certify that any service provided through ByMySide on behalf of any patient is not made in exchange for any express or implied agreement or understanding that I would recommend, prescribe, or use MYALEPT or any other Aegerion product or service for anyone, and any decision to prescribe MYALEPT was and will in the future be based solely on my determination of medical necessity, and that I will not seek reimbursement for any medication or service provided by or through ByMySide from any government program or third-party insurer.

I understand that my patient may authorize Aegerion to provide GL and MYALEPT education, including compliance and persistency support. I understand that this program does not include individual treatment or medical advice to the patient, and it does not replace the medical treatment and care provided by me the patient’s healthcare provider. I acknowledge that the education provided by Aegerion does not replace any obligation I have to inform the patient of the risks associated with MYALEPT or any other treatment I may prescribe.

Prescriber Signature: ______________________________________________________ Date: ________________________________

REMS Attestation: Patient has clinical/laboratory diagnosis consistent with

generalized lipodystrophy (GL)

ICD-10 Diagnosis Code:

E88.1 Lipodystrophy

Other: _________ /_____________________________________

Allergies: None or Specify: ___________________________

Height: _________ inches Weight: _________ pounds

Pretreatment Lab Information:

Test Result DateA1c %Triglycerides mg/dLFasting Glucose mg/dLLeptin Assay Type ___ ng/mL

Patient’s Current Medications:

Patient’s Past Medical History:Does the patient have a family history of generalized

lipodystrophy? Yes No

III. MEDICAL ASSESSMENTAttempted Antidiabetic and Lipid-Lowering Therapies:

Diabetes Therapies (check all that apply)

Long-acting Insulin SGLT2 inhibitor Intermediate-acting Insulin DDP4 inhibitor Fast-acting Insulin GLP-1 receptor agonist U500 Regular Insulin Alpha-glucosidase inhibitors Biguanides-Metformin Meglitinides Thiazolidinediones Amylin agonist Sulfonylurea

Lipid-Lowering Therapies (check all that apply)

Statin Fish oil Ezetimibe Bile acid sequestrants Fibrate Phytosterols

Niacin PCSK9 inhibitor

Physical Findings:Acromegalic features .......................... Yes NoHepatomegaly ........................................ Yes NoSplenomegaly ......................................... Yes NoAcanthosis nigricans ........................... Yes NoHirsutism ................................................... Yes NoMenstrual abnormalities ..................... Yes NoHyperphagia ............................................ Yes No

ByMySide • 1-855-898-2743 (phone) • 1-877-328-9682 (fax)

Please see accompanying full Prescribing Information including Medication Guide and Boxed Warning.

Have your patients complete and sign the enclosed ByMySide Patient Authorization Form to allow a ByMySide Coordinator to work with your patients to navigate their access and afford-ability options and coordinate their Myalept shipments.

©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. BMS/US/005 10-17 Pg 5 of 5


Patient Authorization Form

The purpose of this Authorization form is to permit ByMySide participants to receive additional disease education and information (“Patient Support”) from Aegerion Pharmaceuticals, its affiliates, representatives, agents and contractors (“Aegerion”). Please read this form carefully and ask any questions that you may have.

To be read, completed, and signed by patient or patient’s personal representative.

PLEASE FAX TO 1-877-328-9682

I. AUTHORIZATION TO SHARE PROTECTED HEALTH INFORMATION

By signing this Authorization, I authorize Accredo Specialty Pharmacy (“Accredo”) to disclose my contact information and protected health information (or “PHI”) related to my disease management, including but not limited to my name, medical and pharmacy records and information relating to payment for my disease management, care management and health insurance, as well as all information provided on any Myalept prescription or prescription related to my disease management, to Aegerion Pharmaceuticals, Inc., and those working on its behalf (collectively, “Aegerion”) to provide the Patient Support.

II. PURPOSE OF AUTHORIZATION

The purpose of this Authorization to enable me to obtain patient support from Aegerion, including:

• Investigation of my insurance coverage

• Coordination of benefits and reimbursement support

• Investigation of financial support services and programs, or comparable programs for Myalept that may help me

• Facilitating claims adjudication and submission of claims to third party payers for payment

• Education and access to patient programs related to my disease management including medication adherence support, nutrition support and access to a registered dietitian, treatment and medication reminders and injection training

• Participation in surveys and quality assessment activities to evaluate the effectiveness of the Patient Support

The Authorization also enables me to receive Marketing communications from Aegerion or those acting on its behalf offering programs, services or products of interest to patients taking Myalept.

Aegerion is authorized to contact me by mail, e-mail, text, telephone, and/or any alternative communication method that I request in connection with the Patient Support.

Once my PHI has been disclosed to Aegerion, I understand that federal privacy laws may no longer protect that PHI. However, Aegerion will take reasonable steps to protect my PHI by using and disclosing it only for the purposes described in this Authorization or as otherwise authorized by law.

I understand that I may refuse to sign this Authorization, and that doing so will not affect my ability to participate in ByMySide or to receive treatment or benefits to which I am otherwise entitled. I understand that I am entitled to a copy of this Authorization, and that I may revoke this Authorization at any time, by mailing a letter requesting revo-cation to: Accredo Health Group, Inc. c/o The Myalept Program, 1640 Century Center Parkway Memphis, TN 38134.

I understand that expiration of or revoking this Authorization will end further use and disclosure of my PHI but that it will not affect use or disclosure of PHI that has already been disclosed by Accredo in reliance upon this Authorization.

This Authorization will expire upon my revocation or one year after I receive my last prescription.

AGREED:

Patient Signature: ____________________________________________________________Date: ________________________________

Patient Name (please print): ________________________________________________________________________________________

Personal Representative or Guardian Signature (if applicable): _____________________________________________________________

Personal Representative or Guardian Name (please print): ________________________________________________________________

Relationship to Patient, including the authority for status as Personal Representative: __________________________________________

Address of Patient or Personal Representative: _________________________________________________________________________

Telephone Number: ______________________________________ Email Address: ____________________________________________




MYALEPT® REMS ProgramPrescriber Enrollment Form



Prescriber Information (Please Print *indicates a required field.)


Credentials* MD DO NP PA Other (specify)_____________________________________________________________

Physician Specialty* Endocrinology Family Medicine Cardiology General Internal Medicine Pediatrics Other_______________________________________

Who do you treat? Adults Pediatrics Both


Address 1*



Email* NPI #*

Practice Setting* Solo private practice Group private practice Academic/Hospital affiliated practice Government Institution Other __________________________________________________________

Office Contact


Phone number (if different from above) Fax number (if different from above) Email (if different from above)

If you have any questions, please contact the MYALEPT REMS Program.Phone number: 1-855-669-2537 | Fax number: 1-877-328-9682 | www.MYALEPTREMS.com




• I understand that MYALEPT is not indicated for:o the treatment of complications of partial lipodystrophy.o for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH).o for use in patients with HIV-related lipodystrophy.o for use in patients with metabolic disease including diabetes mellitus and hypertriglyceridemia without






Signature* ______________________________________________________________ Date*____________________________

Overview of MYALEPT REMS Prescriber Enrollment Form

MYALEPT is available only through the MYALEPT REMS Program. To prescribe MYALEPT, a prescriber must:

ReviewthePrescribingInformation

Review and completethePrescriberTrainingModuleatwww.myaleptrems.com

Complete and submitaMYALEPTREMSPrescriptionAuthorizationFormforeachnewprescription

Complete and faxthisone-timeMYALEPTREMSProgramPrescriberEnrollmentForm.

Forms must be faxed to the MYALEPT REMS Program at 1-877-328-9682.

Allinformationisrequired.No photo copies, cross-outs, or white outs will be accepted.

Sign and datethecompletedform.


1

2

3

1

2

3

©2018AegerionPharmaceuticals,Inc.MyaleptisaregisteredtrademarkofAegerionPharmaceuticals,Inc.Allrightsreserved.MYA/US/15303-18

MYALEPT® REMS Program Prescriber Enrollment Form

If you have any questions, please contact the MYALEPT REMS Program.

Phone number: 1-855-669-2537 | Fax number: 1-877-328-9682 | www.MYALEPTREMS.com




Prescriber Information (Please Print *indicates a required field.) Full Name (first, middle, last)*

Credentials*

MD DO NP PA Other (specify) _____________________________________________________

Physician Specialty* Endocrinology General Internal Medicine

Family Medicine Pediatrics

Cardiology Other ______________________________

Who do you treat?

Adults Pediatrics Both


Address 1*



Email* NPI #*

Practice Setting* Solo private practice Group private practice Academic/ Hospital affiliated practice Government Institution Other _____________________

Office Contact Full Name (first, middle, last)*

Phone number (if different from above) Fax number (if different from above) Email (if office contact is provided)


I understand that MYALEPT is indicated as an adjunct to diet as replacement therapy to treat the complications ofleptin-deficiency in patients with congenital or acquired generalized lipodystrophy.

I affirm that my patient has a clinical diagnosis consistent with generalized lipodystrophy, and that my patient (or their

caregiver) has been properly informed of the benefits and risks of MYALEPT therapy. I understand that MYALEPT is not indicated for:

o the treatment of complications of partial lipodystrophy.o for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH).

o for use in patients with HIV-related lipodystrophy.o for use in patients with metabolic disease including diabetes mellitus and hypertriglyceridemia without concurrent evidence

of congenital or acquired generalized lipodystrophy. I understand that MYALEPT is contraindicated in patients with general obesity not associated with congenital leptin deficiency. I understand that MYALEPT is associated with serious adverse events due to the development of anti-metreleptin antibodies

that neutralize endogenous leptin and/or MYALEPT. I agree to test for neutralizing antibodies in patients who experience severe infections or if I suspect MYALEPT is no

longer working (e.g., loss of glycemic control, or increases in triglycerides). I understand that MYALEPT is associated with a risk of lymphoma. I understand I must carefully consider the risks of treatment with MYALEPT in patients with significant hematological abnormalities and/or acquired generalized lipodystrophy.

Signature* ________________________________________________________ Date* ___________________________

Pg 1 of 1





PLEASE FAX TO 1-877-328-9682









• Education and access to patient programs related to my disease management including medication adherence support, nutrition support and access to a registered dietitian, treatment and medication reminders and injection training








AGREED:








ByMySide • 1-855-669-2537 (phone) • 1-877-328-9682 (fax)©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. BMS/US/004 10-17

Please see full Prescribing Information including Medication Guide and Boxed Warning.

Overview of MYALEPT ByMySide Patient Authorization Form


This patient support from Aegerion is available to ByMySide participants for free, at no additional cost.

Should patient decide not to sign and authorize this patient support from Aegerion, the patient can still participate in ByMySide and receive treatment and benefits from that program.

Patient Signature and all information is required to be completed to authorize this added patient support from Aegerion.


1

2

3

1

2

3

©2018 Aegerion Pharmaceuticals, Inc. Myalept is a registered trademark of Aegerion Pharmaceuticals, Inc. All rights reserved. BMS/US/010 03-18

Pg 1 of 1





PLEASE FAX TO 1-877-328-9682









• Education and access to patient programs related to my disease management including medication adherencesupport, nutrition support and access to a registered dietitian, treatment and medication reminders and injectiontraining








AGREED:









©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. BMS/US/004 10-17

Please see full Prescribing Information including Medication Guide and Boxed Warning.

Pg 4 of 5


Enrollment Form

HEALTHCARE PROVIDER: Please complete all sections of this form and fax to 1-877-328-9682.

I. PATIENT INFORMATION

Patient is (choose one): New Currently Receiving Myalept

Patient Name (First MI Last): ________________________________________________________________________________________

Address: _______________________________________________ City: ___________________ State: _____ Zip: ___________

Date of Birth: _____ /_____ / _____ Gender: Male Female Email: ________________________________________________

Primary Contact: Patient Legal Representative (if applicable): ________________________________________________________

Preferred Phone: _____________________ OK to leave message Alternate Phone: ____________________ OK to leave message

II. INSURANCE INFORMATIONPlease send a copy of the front and back of the medical and pharmacy insurance cards. If not available, please complete the fields below.Medical Insurance Prescription Insurance

Policy Holder Name: ______________________________________ Policy Holder Name: ____________________________________

Medical Insurance Phone: __________________________________ Prescription Insurance Phone: _____________________________

Medical Policy #: _________________Group # ________________ Prescription Policy #: ______________ Group # _____________

IV. PRESCRIBER INFORMATION

Prescriber Name: ________________________________________ Office Contact Name: ___________________________________

Prescriber Specialty: ______________________________________ Office Contact Phone: ___________________________________

Phone: ______________________ Fax: _______________________ Office Contact Email: ____________________________________

NPI #: _______________________ Lic #: ______________________ Tax ID #: ______________________________________________

REVIEW AND SIGN THE ACKNOWLEDGMENT AND AUTHORIZATION

I acknowledge that I have obtained any required authorization or other permission necessary to release the patient’s protected health infor-mation and the information on this form and any prescription to Aegerion Pharmaceuticals, its affiliates and their representatives, agents, and contractors (“Aegerion”), for the purposes of providing product support services, including but not limited to conveying personal information to dispensing pharmacies. I further certify that any service provided through ByMySide on behalf of any patient is not made in exchange for any express or implied agreement or understanding that I would recommend, prescribe, or use MYALEPT or any other Aegerion product or service for anyone, and any decision to prescribe MYALEPT was and will in the future be based solely on my determination of medical necessity, and that I will not seek reimbursement for any medication or service provided by or through ByMySide from any government program or third-party insurer.

I understand that my patient may authorize Aegerion to provide GL and MYALEPT education, including compliance and persistency support. I understand that this program does not include individual treatment or medical advice to the patient, and it does not replace the medical treatment and care provided by me the patient’s healthcare provider. I acknowledge that the education provided by Aegerion does not replace any obligation I have to inform the patient of the risks associated with MYALEPT or any other treatment I may prescribe.

Prescriber Signature: ______________________________________________________ Date: ________________________________

REMS Attestation: Patient has clinical/laboratory diagnosis consistent with

generalized lipodystrophy (GL)

ICD-10 Diagnosis Code:

E88.1 Lipodystrophy

Other: _________ /_____________________________________

Allergies: None or Specify: ___________________________

Height: _________ inches Weight: _________ pounds

Pretreatment Lab Information:

Test Result DateA1c %Triglycerides mg/dLFasting Glucose mg/dLLeptin Assay Type ___ ng/mL

Patient’s Current Medications:

Patient’s Past Medical History:Does the patient have a family history of generalized

lipodystrophy? Yes No

III. MEDICAL ASSESSMENTAttempted Antidiabetic and Lipid-Lowering Therapies:

Diabetes Therapies (check all that apply)

Long-acting Insulin SGLT2 inhibitor Intermediate-acting Insulin DDP4 inhibitor Fast-acting Insulin GLP-1 receptor agonist U500 Regular Insulin Alpha-glucosidase inhibitors Biguanides-Metformin Meglitinides Thiazolidinediones Amylin agonist Sulfonylurea

Lipid-Lowering Therapies (check all that apply)

Statin Fish oil Ezetimibe Bile acid sequestrants Fibrate Phytosterols

Niacin PCSK9 inhibitor

Physical Findings:Acromegalic features .......................... Yes NoHepatomegaly ........................................ Yes NoSplenomegaly ......................................... Yes NoAcanthosis nigricans ........................... Yes NoHirsutism ................................................... Yes NoMenstrual abnormalities ..................... Yes NoHyperphagia ............................................ Yes No



©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. BMS/US/005 10-17



Patient Information









Insured Employer


Policy Number










Address 1




Overview of MYALEPT (metreleptin) REMS Prescription Authorization Form

To prescribe MYALEPT, healthcare professionals must be certified in the MYALEPT Risk Evaluation and Mitigation Strategy (REMS) Program. For certification visit www.myaleptrems.com or call 1-855-6MYALEPT (1-855-669-2537).

The MYALEPT REMS Program Prescription Authorization Form is one of several forms that must be completed for the prescription to be processed. This form consists of 2 pages. All of the fields are required information and need to completed.

No photo copies, cross-outs, or white outs will be accepted.

Both patient phone number and email (if available) are required for the prescription to be processed.

A photocopy of both sides of your patient’s medical and pharmacy insurance cards must be submitted with this form. Your office should not share any patient information unless it has a valid patient authorization on file.

Check the appropriate box to indicate where first shipment should be sent.


1

2

3

1

2

3

4

4



The following is a prescription form for the required ancillary supplies for MYALEPT reconstitution and administration. This can be faxed back to 1-877-328-9682 with the rest of this page and the previous page, or torn off and given to your patient to fill at another pharmacy.

Patient Information


MYALEPT Supplies Prescription

Required supplies (please note – the maximum number per supply is specified below. Pharmacy will adjust to individual patient needs).

For Reconstitution62 of 3 mL syringe (22G x 1 in. needle) Refills #____

Water for reconstitution (select one):5 of 30 mL vials of BWFI Refills #____31 of 5 mL vials of SWFI (for neonates and infants) Refills #____

For AdministrationNurse Injection Training Requested31G 6mm 1 mL insulin syringe Refills #____ 31G 6mm 3/10 mL insulin syringe (for pediatrics) Refills #____ Other:______________________________________________



Addresss

City State ZIP code Office Phone

License # NPI #

MYALEPT 5mg/mL Injection Prescription

Starting Dose: 0.06 mg/kg 2.5 mg 5 mg Maintenance Dose: _____________________

Patient Weight Days Supply Refills #

Directions (e.g., by subcutaneous injection once daily)

List or Attach a List of Concomitant Medications Allergies

Patient Information







• I understand that MYALEPT is not indicated for: o the treatment of complications of partial lipodystrophy.o for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH).o for use in patients with HIV-related lipodystrophy.o for use in patients with metabolic disease including diabetes mellitus and hypertriglyceridemia without






Physician Signature ______________________________________________________ Date ________________________________

Physician Signature_________________________ Date___________ Physician Signature_________________________ Date___________ Product Selection Permitted Dispense as Written


©2018 Aegerion Pharmaceuticals, Inc. Myalept is a registered trademark of Aegerion Pharmaceuticals, Inc. All rights reserved. MYA/US/152 03-18

Your signature is required 5 times on this form (1 for the attestation, 2 for the prescription, and 2 for the ancillary supplies).

Starting dose and maintenance dose must both be included on this form. For new patients, if the maintenance dose has not been established, the starting dose can be repeated here. Refer to the Dosing and Administration section of the MYALEPT PI for further information on dosage adjustments. Or call to speak with an Accredo Pharmacist at 1-855-6MYALEPT (1-855-669-2537)

Indicate the number of days supplied, as well as refills (based on number of days supplied with original prescription).

You must indicate how the prescription is to be administered by your patient.

Please submit this section of the form for your patient to receive ancillary supplies at no cost from the specialty pharmacy.

Please indicate the number of refills for both types of syringes (3 mL syringes for reconstitution and 1 mL syringes for administration). Also indicate the number of refills and type of water for reconstitution (BWFI for children and adults and SWFI for neonates and infants).

Use this space to prescribe a different size needle for admini-stration and to request injection training by a ByMySide nurse.


5

6

7

8

9

10

11

78

5

5

6

9

10

5

11

Overview of MYALEPT (metreleptin) REMS Prescription Authorization Form



Patient Information









Insured Employer


Policy Number










Address 1






The following is a prescription form for the required ancillary supplies for MYALEPT reconstitution and administration. This can be faxed back to 1-877-328-9682 with the rest of this page and the previous page, or torn off and given to your patient to fill at another pharmacy.

Patient Information


MYALEPT Supplies Prescription

Required supplies (please note – the maximum number per supply is specified below. Pharmacy will adjust to individual patient needs).

For Reconstitution 62 of 3 mL syringe (22G x 1 in. needle) Refills #____

Water for reconstitution (select one):

5 of 30 mL vials of BWFI Refills #____ 31 of 5 mL vials of SWFI (for neonates and infants) Refills #____

For Administration Nurse Injection Training Requested 31G 6mm 1 mL insulin syringe Refills #____ 31G 6mm 3/10 mL insulin syringe (for pediatrics) Refills #____ Other:______________________________________________



Addresss

City State ZIP code Office Phone

License # NPI #

MYALEPT 5mg/mL Injection Prescription

Starting Dose: 0.06 mg/kg 2.5 mg 5 mg Maintenance Dose: _____________________

Patient Weight Days Supply Refills #

Directions (e.g., by subcutaneous injection once daily)

List or Attach a List of Concomitant Medications Allergies

Patient Information





• I understand that MYALEPT is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin-deficiency in patients with congenital or acquired generalized lipodystrophy.

• I affirm that my patient has a clinical diagnosis consistent with generalized lipodystrophy, and that my patient (or their caregiver) has been properly informed of the benefits and risks of MYALEPT therapy.

• I understand that MYALEPT is not indicated for: o the treatment of complications of partial lipodystrophy.o for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH).o for use in patients with HIV-related lipodystrophy.o for use in patients with metabolic disease including diabetes mellitus and hypertriglyceridemia without






Physician Signature ______________________________________________________ Date ________________________________



©2017 Aegerion Pharmaceuticals, Inc. All rights reserved. Myalept is a registered trademark of Aegerion Pharmaceuticals. MYA/US/138 12-17

One Main Street, Suite 800 Cambridge, MA 02142

www.novelion.com

FDA REQUIRED SAFETY INFORMATION RISK OF SEVERE INFECTIONS

MYALEPT® (metreleptin) for Injection

Dear Certified Prescriber:

A recent assessment of the Myalept REMS (Risk Evaluation Mitigation Strategy) Program has demonstrated that prescribers are not fully aware of the 1) serious risk of severe infections associated with the use of MYALEPT and 2) the availability of neutralizing antibody testing.

Therefore, Aegerion has made updates to the MYALEPT REMS Prescriber Training Module to emphasize:

the risk of severe infections that may result from the development of anti-metreleptinantibodies, and

the availability of testing for neutralizing activity in patients who experience severeinfections, or if you suspect that Myalept is no longer working

We remind you that the purpose of the MYALEPT REMS Prescriber Training Module is to educate prescribers about:

The development of anti-metreleptin antibodies that neutralize endogenous leptin and/orMyalept and the serious adverse events that may result from these antibodies, including:

o severe infections,o loss of glycemic controlo increases in triglycerides

The risk of lymphoma, and

Appropriate patient selectionFor instructions on how to submit samples for neutralizing antibody testing contact Aegerion Pharmaceuticals, Inc. (Aegerion) at 1-866-216-1526.

Certified Prescribers are encouraged to review the revised prescriber training program that is now located on the MYALEPT REMS website: www.myaleptREMS.com. However, no action is required to maintain your certification.

If you have any questions on the above, please contact the MYALEPT REMS Program at 1-855-669-2537.

Sincerely,

Dr. Charles Gerrits Aegerion Pharmaceuticals, Inc.

Attachment: Myalept Prescribing Information

http://www.myaleptrems.com/

Documents

Enrollment in the Myalept ByMySide Support Programmyaleptpro.com/sites/default/files/mya_starter_kit_documents_2018… · Fax the completed and signed forms to 1-877-328-9682 PRESCRIBING