GLossary

A1C test
A blood test that correlates with a person’s average blood glucose level over the span of 2-3 months.

Bacteriostatic water for injection (BWFI) 
A sterile water for injection used to mix Myalept for adults and older children. BWFI contains benzyl alcohol added as a preservative to keep bacteria from reproducing. BWFI should not be used to mix Myalept for infants.

ByMySide
A comprehensive program of support services and resources available to Myalept patients at no cost to them.

Congenital
A condition or disease that is present at birth, whether or not it is inherited.

Deficiency
A lack or shortage.

Generalized Lipodystrophy (GL)
A rare disease that results in having little to no fat tissue all over the body. Generalized means all over, Lipo means fat, and Dystrophy means abnormal loss of tissue.

Genetic
Relating to something inherited from parents. If a health problem is genetic, it means you inherited the problem genes from at least one of your parents.

Hypoglycemia
Also called low blood glucose, or low blood sugar, and occurs when blood glucose drops below normal levels.

Insulin
A hormone that regulates the amount of glucose in the blood, or blood sugar.

Leptin
A hormone that helps the body process fat.

Metabolic
Relating to metabolism, the biochemical processes that occur within you, such as the way your body breaks down sugar or fat.

Pancreas
A large organ of the body located near the stomach that plays an essential role in helping the body digest food. It also produces and secretes hormones that regulate the body’s sugar level.

REMS
Myalept Risk Evaluation and Mitigation Strategy (REMS) Program is an FDA program designed to enhance drug safety.

Sharps disposal container
A safety container that is used for the disposal of medical needles.

Sulfonylurea
A type of anti-diabetic medication that acts on the beta cells of the pancreas to increase the secretion of insulin.

Triglycerides
A type of fat (lipid) found in your blood and stored in fat cells.

Water for injection (preservative free) (WFI)
Appropriate liquid used to mix Myalept for use in newborns or infants.

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.