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Guide, Feedback, and Issue Reporting
 * This website is for US audiences only
 * Medication Guide
 * Instructions for Use
 * Important Safety Information
 * Prescribing Information
 * REMS
 * For Healthcare Providers

 * GL & LEPTIN
 * How Myalept Works
 * Taking Myalept
 * GL Stories
 * FAQs
 * RESOURCES & SUPPORT

 


IS MYALEPT FOR YOU?  

Myalept is a prescription medication that replaces leptin, an important hormone
that people with generalized lipodystrophy (GL) are missing. It’s used with a
doctor-recommended diet and treats problems caused by not having enough leptin
in people with GL.


WHAT IS LEPTIN?

Leptin is a hormone normally present in the body. But people with GL have low
levels of leptin, which causes health problems.


ABOUT MYALEPT

If you have GL, Myalept replaces the leptin the body is missing. Because Myalept
acts similarly to the body’s naturally occurring leptin, it can help treat some
of the problems associated with GL.


SUPPORT JUST FOR YOU

The Chiesi Total Care support team is here to help with the support and
resources you need, including personalized nutrition consultations and
assistance with insurance issues.

IMPORTANT SAFETY INFORMATION
+

What is Myalept?

Myalept® (metreleptin) is a leptin replacement therapy used with a
doctor-recommended diet to treat problems caused by not having enough leptin
(leptin deficiency) in people with generalized lipodystrophy.

 * It is not known if Myalept is safe and effective when used to treat problems
   (complications) caused by partial lipodystrophy or to treat liver disease,
   including non-alcoholic steatohepatitis (NASH)
 * Myalept should not be used to treat people with HIV-related lipodystrophy or
   people with metabolic disease, including diabetes mellitus and
   hypertriglyceridemia, without signs or symptoms of congenital or acquired
   generalized lipodystrophy.

Important Safety Information

Myalept is only available through a restricted program called the Myalept Risk
Evaluation and Mitigation Strategy (REMS) Program. Your doctor must be enrolled
and certified in the program in order to prescribe Myalept.

Myalept may cause serious side effects, including:

 * risk for developing certain proteins called neutralizing antibodies that may
   reduce how well your own leptin or Myalept works. Side effects of these
   antibodies may include infection, problems with blood sugar (including
   diabetes), or an increase in triglycerides.
 * increased risk of a type of blood cancer called lymphoma.

You should not take Myalept if you:

 * have general obesity not caused by a congenital leptin deficiency.
 * are allergic to metreleptin or any of the ingredients in Myalept. Symptoms of
   an allergic reaction include rash, itching (hives), swelling of face, lips,
   tongue, or throat, problems breathing or swallowing, fainting or dizziness,
   rapid heartbeat.

Before using Myalept, tell your doctor if you have any medical conditions
including if you:

 * have or have had problems with your blood cells, including low blood cell
   counts (especially your white blood cells), bone marrow, immune system,
   pancreas, swollen lymph nodes, lymphoma, high blood triglyceride levels, or
   use insulin or a sulfonylurea.
 * are pregnant or plan to become pregnant as it is unknown if Myalept will harm
   your unborn baby. If you become pregnant while using Myalept, talk to your
   healthcare provider about registering with a program to collect information
   about the outcomes of moms and babies exposed to Myalept during pregnancy.
   You can enroll in the Myalept program by calling 1-855-669-2537.
 * are nursing or plan to nurse. You should not nurse while you take Myalept.

Other possible side effects

The most common side effects of Myalept include headache, low blood sugar,
decreased weight, and/or abdominal pain.

You may get low blood sugar (hypoglycemia) if you take Myalept with other
medicines used to lower blood sugar, such as insulin or sulfonylurea. Your doses
of these medications may need to be lowered while you use Myalept. Tell your
doctor right away if you experience shakiness, sweating, headache, drowsiness,
weakness, dizziness, confusion, irritability, hunger, fast heartbeat, or a
jittery feeling because these may be signs of low blood sugar (hypoglycemia).

For newborns and infants, mix Myalept with sterile water for injection
(preservative-free) (WFI). Serious side effects including death have happened in
newborns or infants who have received the preservative benzyl alcohol.
Bacteriostatic water for injection contains benzyl alcohol and it should not be
used to mix Myalept for newborns and infants.

Myalept may worsen symptoms caused by certain problems in your immune system
(autoimmune disorder). Ask your doctor about what symptoms you should watch for
that may require further testing.

Talk to your doctor about any side effect that bothers you or that does not go
away. These are not all the possible side effects of Myalept. For more
information, speak to your doctor or pharmacist. Tell your doctor about all the
medications you take, including prescription and nonprescription medicines,
vitamins, and herbal supplements. Take Myalept exactly as your doctor instructs
you.

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.
This is the most important information about Myalept. For more detailed
information, please see the patient Medication Guide and full Prescribing
Information including Boxed Warning.
IMPORTANT SAFETY INFORMATION

What is Myalept?

Myalept® (metreleptin) is a leptin replacement therapy used with a
doctor-recommended diet to treat problems caused by not having enough leptin
(leptin deficiency) in people with generalized lipodystrophy.

 * It is not known if Myalept is safe and effective when used to treat problems
   (complications) caused by partial lipodystrophy or to treat liver disease,
   including non-alcoholic steatohepatitis (NASH)
 * Myalept should not be used to treat people with HIV-related lipodystrophy or
   people with metabolic disease, including diabetes mellitus and
   hypertriglyceridemia, without signs or symptoms of congenital or acquired
   generalized lipodystrophy.

Important Safety Information

Myalept is only available through a restricted program called the Myalept Risk
Evaluation and Mitigation Strategy (REMS) Program. Your doctor must be enrolled
and certified in the program in order to prescribe Myalept.

Myalept may cause serious side effects, including:

 * risk for developing certain proteins called neutralizing antibodies that may
   reduce how well your own leptin or Myalept works. Side effects of these
   antibodies may include infection, problems with blood sugar (including
   diabetes), or an increase in triglycerides.
 * increased risk of a type of blood cancer called lymphoma.

You should not take Myalept if you:

 * have general obesity not caused by a congenital leptin deficiency.
 * are allergic to metreleptin or any of the ingredients in Myalept. Symptoms of
   an allergic reaction include rash, itching (hives), swelling of face, lips,
   tongue, or throat, problems breathing or swallowing, fainting or dizziness,
   rapid heartbeat.

Before using Myalept, tell your doctor if you have any medical conditions
including if you:

 * have or have had problems with your blood cells, including low blood cell
   counts (especially your white blood cells), bone marrow, immune system,
   pancreas, swollen lymph nodes, lymphoma, high blood triglyceride levels, or
   use insulin or a sulfonylurea.
 * are pregnant or plan to become pregnant as it is unknown if Myalept will harm
   your unborn baby. If you become pregnant while using Myalept, talk to your
   healthcare provider about registering with a program to collect information
   about the outcomes of moms and babies exposed to Myalept during pregnancy.
   You can enroll in the Myalept program by calling 1-855-669-2537.
 * are nursing or plan to nurse. You should not nurse while you take Myalept.

Other possible side effects

The most common side effects of Myalept include headache, low blood sugar,
decreased weight, and/or abdominal pain.

You may get low blood sugar (hypoglycemia) if you take Myalept with other
medicines used to lower blood sugar, such as insulin or sulfonylurea. Your doses
of these medications may need to be lowered while you use Myalept. Tell your
doctor right away if you experience shakiness, sweating, headache, drowsiness,
weakness, dizziness, confusion, irritability, hunger, fast heartbeat, or a
jittery feeling because these may be signs of low blood sugar (hypoglycemia).

For newborns and infants, mix Myalept with sterile water for injection
(preservative-free) (WFI). Serious side effects including death have happened in
newborns or infants who have received the preservative benzyl alcohol.
Bacteriostatic water for injection contains benzyl alcohol and it should not be
used to mix Myalept for newborns and infants.

Myalept may worsen symptoms caused by certain problems in your immune system
(autoimmune disorder). Ask your doctor about what symptoms you should watch for
that may require further testing.

Talk to your doctor about any side effect that bothers you or that does not go
away. These are not all the possible side effects of Myalept. For more
information, speak to your doctor or pharmacist. Tell your doctor about all the
medications you take, including prescription and nonprescription medicines,
vitamins, and herbal supplements. Take Myalept exactly as your doctor instructs
you.

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.
This is the most important information about Myalept. For more detailed
information, please see the patient Medication Guide and full Prescribing
Information including Boxed Warning.

 * Glossary
 * Terms and Conditions
 * Privacy Policy
 * Accessibility

© 2024 Chiesi USA. All rights reserved. MYALEPT is a registered trademark owned
by the Chiesi Group. Chiesi Total CareSM is a service mark owned by the Chiesi
Group.PP-ML-0021 V1.0

This information is for US healthcare professionals only.

Click “continue” only if you are a US healthcare professional.   

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