Metreleptin 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.

Metreleptin is not for use in people who are obese or have lipodystrophy caused by HIV or AIDS.

Metreleptin is available only under a special program. You must be registered in the program and understand the risks and benefits of metreleptin.

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

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), or worsening of your lipodystrophy symptoms. If you are diabetic, tell your doctor if you have any changes in your blood sugar levels.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Metreleptin is injected under the skin. A healthcare provider will teach you how to properly use the medication by yourself. Metreleptin should not be injected into a muscle or vein.

Metreleptin is usually given once daily at any time of day, with or without food.

Metreleptin doses are based on weight (especially in children and teenagers). Your dose needs may change if you gain or lose weight.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Metreleptin must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine. Do not mix metreleptin with other medicines in the same vial or syringe.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

When preparing a metreleptin 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.

Store unmixed metreleptin 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, or if the expiration date on the label has passed.

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

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Low blood sugar (hypoglycemia) can occur during treatment with metreleptin, especially if you also use insulin or oral diabetes medicine. Ask your doctor how to best treat low blood sugar. If you are diabetic, check your blood sugar carefully while using metreleptin.

Usual Adult Dose for Lipodystrophy:

Weight 40 kg or less (males and females):
-Initial dose: 0.06 mg/kg subcutaneously once a day
-Adjust dose in 0.02 mg/kg increments based on clinical response
-Maximum dose: 0.13 mg/kg/day

Weight greater than 40 kg:
-Initial dose: Males: 2.5 mg subcutaneously once a day
-Initial dose: Females: 5 mg subcutaneously once a day
-Adjust dose in 1.25 to 2.5 mg increments based on clinical response
-Maximum dose: 10 mg/day

Comments: Dose adjustments should be made based on clinical response (e.g., metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss).

Use: As an adjunct to diet, used as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Usual Pediatric Dose for Lipodystrophy:

Weight 40 kg or less (males and females):
-Initial dose: 0.06 mg/kg subcutaneously once a day
-Adjust dose in 0.02 mg/kg increments based on clinical response
-Maximum dose: 0.13 mg/kg/day

Weight greater than 40 kg:
-Initial dose: Males: 2.5 mg subcutaneously once a day
-Initial dose: Females: 5 mg subcutaneously once a day
-Adjust dose in 1.25 to 2.5 mg increments based on clinical response
-Maximum dose: 10 mg/day

Comments: Dose adjustments should be made based on clinical response (e.g., metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss).

Use: As an adjunct to diet, used as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

You should not use metreleptin if you are allergic to it. Metreleptin is not for use in treating obesity that is unrelated to leptin deficiency.

Tell your doctor if you have ever had:

• a blood cell disorder, or low white blood cell (WBC) counts;

• liver disease (including "fatty liver");

• diabetes (especially if you use insulin or oral diabetes medicine);

• pancreatitis;

• high triglycerides (a type of fat in the blood);

• any other metabolic disorder;

• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;

• bone marrow suppression; or

• lymphoma (cancer of the lymph nodes).

Tell your doctor if you are pregnant or plan to become pregnant. Having lipodystrophy may increase complications such as miscarriage, stillbirth, high birth weight, diabetes, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating lipodystrophy may outweigh any risks to the baby.

It may not be safe to breastfeed while using metreleptin. Ask your doctor about any risk.

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause loss of appetite and weight loss.

If you use insulin, do not inject metreleptin into the same skin area where your insulin has been injected.

Do not stop using metreleptin suddenly. Follow your doctor's instructions about tapering your dose.

Get emergency medical help if you have signs of an allergic reaction: 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 (such as fever, chills, mouth sores, or trouble breathing);

• 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

• pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common side effects of metreleptin may include:

• low blood sugar;

• 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 affect metreleptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.