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.

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.

Take Myalept 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.

Myalept 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.

Take a vial out of the refrigerator and allow it to reach room temperature before preparing your dose.

When preparing a Myalept dose for an infant: Do not use a diluent called Bacteriostatic Water for Injection (BWFI). BWFI contains an ingredient that can cause serious side effects or death in very young infants or premature babies. Use only Sterile Water for Injection (WFI) or the diluent that your doctor or pharmacist has recommended.

Do not shake the mixed medicine. Prepare your dose when you are ready to give an injection. Do not use if the medicine looks cloudy or has particles in it. Mix a new vial or call your pharmacist for new medicine.

Myalept mixed with BWFI must be used within 3 days. Store the mixture in the refrigerator.

Myalept mixed with WFI must be used right away. WFI contains no preservative. Do not save for later use.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Do not mix Myalept with other medicines in the same vial or syringe. If you use insulin, do not inject this medicine into the same skin area where your insulin has been injected.

If you are diabetic, check your blood sugar carefully while using Myalept.

Low blood sugar (hypoglycemia) can occur during treatment with this medicine. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Ask your doctor how to best treat low blood sugar. Be sure your family and caregivers also know how to recognize the signs of low blood sugar and how to help you treat it.

Usual Adult Dose for Lipodystrophy:

40 Kg or less:
-Initial dose: 0.06 mg/kg/day subcutaneously. Increase or decrease by 0.02 mg/kg
-Maximum dose: 0.13 mg/kg/day

Greater than 40 Kg:
Males:
-Initial dose: 2.5 mg/day subcutaneously. Increase or decrease by 1.25 to 2.5 mg/day
-Maximum dose: 10 mg/day

Female:
-Initial dose: 5 mg/day subcutaneously. Increase or decrease by 1.25 to 2.5 mg/day
-Maximum dose: 10 mg/day

Uses: Replacement therapy for leptin deficiency in patients with congenital or acquired generalized lipodystrophy, as adjunct to diet.

Usual Pediatric Dose for Lipodystrophy:

40 Kg or less:
-Initial dose: 0.06 mg/kg/day subcutaneously. Increase or decrease by 0.02 mg/kg
-Maximum dose: 0.13 mg/kg/day

Greater than 40 Kg:
Males:
-Initial dose: 2.5 mg/day subcutaneously. Increase or decrease by 1.25 to 2.5 mg/day
-Maximum dose: 10 mg/day

Female:
-Initial dose: 5 mg/day subcutaneously. Increase or decrease by 1.25 to 2.5 mg/day
-Maximum dose: 10 mg/day

Comments: Use preservative-free sterile water for injection (WFI) to reconstitute metreleptin for pediatric injection.

Uses: Replacement therapy for leptin deficiency in patients with congenital or acquired generalized lipodystrophy, as adjunct to diet.

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.

Myalept 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 Myalept 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 Myalept 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.

Use the missed dose as soon as you remember. Then use your next daily dose at the usual time. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not stop using Myalept suddenly. Stopping suddenly may cause serious medical problems. Follow your doctor's instructions about tapering your dose.

Get emergency medical help if you have any signs of an allergic reaction to Myalept: hives; difficult breathing; rapid heart rate, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

In some people, metreleptin 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);

• changes in your blood sugar levels (if you are diabetic); or

• worsening of your lipodystrophy symptoms.

Also call your doctor at once if you have:

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

• symptoms of a pancreas problem--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Common Myalept side effects may include:

• headache;

• weight loss; or

• stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with metreleptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.