GL & Leptin

People with GL do not have enough leptin

Generalized lipodystrophy (GL) is a rare condition that results in having little to no fat tissue all over the body.

Not only does the condition affect your appearance, the lack of body fat results in a loss of leptin, an important hormone that helps the body function properly.

Leptin is important because it helps control certain metabolic processes in the body. Not having enough leptin can lead to health problems such as high triglycerides (fat in the blood) and high blood sugar.

This is where Myalept®, the only FDA-approved leptin replacement therapy, may be able to help. Talk to your doctor to see if Myalept is right for you.

Leptin helps control certain important metabolic processes in the body

Controlling how fat is broken down or stored. When fat is not used and stored properly in GL, it can collect as triglycerides in the blood.

Helping the body respond to insulin. Insulin is a hormone produced by the pancreas that helps manage levels of sugar in the blood. Without leptin, the body can develop insulin resistance, which may lead to diabetes in people with GL

2 Things to Know About Leptin

Leptin is a hormone normally present in the body. It helps control certain important metabolic processes in the body, including:

1

Controlling how fat is broken down or stored. When fat is not used and stored properly in people with GL, it can collect as triglycerides in the blood.

2

Helping the body respond to insulin. Insulin is a hormone produced by the pancreas that helps manage levels of sugar in the blood. Without leptin, the body can develop insulin resistance, which may lead to diabetes in people with GL.

People with GL have low levels of leptin, which causes health problems.

How GL and Low Leptin Levels Can Affect You

To track these problems, people with GL should be aware of 3 important measures:

When blood sugar levels are too high, the risk of developing diabetes can increase in people with GL. Not having enough leptin can cause these levels to be higher than normal in people with GL. Blood tests ordered by your doctor can show the level of triglycerides and sugars in the blood.

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.

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:

You should not take Myalept if you:

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

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.