Metreleptin

Generic name: Metreleptin
Brand names: Myalept
Dosage form: subcutaneous powder for injection (11.3 mg)
Drug class: Miscellaneous metabolic agents

Usage of Metreleptin

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.

Metreleptin side effects

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.

Before taking Metreleptin

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.

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How to use 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/dayWeight 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/dayComments: 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:

Warnings

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.

What other drugs will affect Metreleptin

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.

Disclaimer

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