Myalept

Generic name: Metreleptin
Drug class: Miscellaneous metabolic agents

Usage of Myalept

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 side effects

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.

Before taking Myalept

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.

Relate drugs

How to use Myalept

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.

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.

What other drugs will affect Myalept

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.

Disclaimer

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