Description

What is Myalept (metreleptin) ?

Myalept is used together with diet to treat complications caused by leptin deficiency in people who have lipodystrophy (also called fat redistribution). Lipodystrophy (LIP-oh-DIS-tro-fee) is a problem with the way the body stores fat.

Myalept is not for use in people who have lipodystrophy caused by taking medicine to treat HIV or AIDS.

Myalept may also be used for purposes not listed in this medication guide.

Myalept (metreleptin) Warnings

In some people, Myalept can trigger an immune response to the medicine, making it less effective or causing certain side effects. Call your doctor if you develop any signs of a new infection (fever, chills, night sweats, weight loss, swollen glands, flu symptoms), or worsening of your lipodystrophy symptoms. If you are diabetic, tell your doctor if you have any changes in your blood sugar levels.

Before taking Myalept (metreleptin)

You should not use Myalept if you are allergic to metreleptin.

This medicine is not for use in treating obesity that is unrelated to leptin deficiency.

Metreleptin is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks of taking this medication.

To make sure Metreleptin is safe for you, tell your doctor if you have:

• a blood cell disorder, or history of low white blood cell (WBC) counts;
• liver disease (including “fatty liver”);
• diabetes (especially if you use insulin or oral diabetes medicine);
• high triglycerides (a type of fat in the blood);
• any other metabolic disorder;
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
• a history of pancreatitis;
• bone marrow suppression; or
• a history of lymphoma (cancer of the lymph nodes).

It is not known whether Metreleptin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether metreleptin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I use Myalept?

Take Metreleptin exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Tell your doctor if you have any changes in weight. Metreleptin doses are based on weight, especially in children.

Myalept is injected under the skin. You may be shown how to use injections at home. Myalept should not be injected into a muscle or vein. Do not self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Metreleptin is usually given once daily. Use the medicine at the same time each day. You may use this medicine with or without food.

Myalept is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Store unmixed vials in their original container in the refrigerator. Protect from light. Do not freeze. Do not use the medicine if the powder in the vial has changed colors. Throw away any vials not used before the expiration date on the medicine label.

Important Safety Information

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

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 Metreleptin include headache, low blood sugar, decreased weight, and/or abdominal pain.

You may get low blood sugar (hypoglycemia) if you take Metreleptin 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 Metreleptin. 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 Metreleptin 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.

Metreleptin 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 Metreleptin exactly as your doctor instructs you.