Myalept

Drug List

Myalept

Drug Name

Myalept (Metreleptin)

Manufactured By

Aegerion Pharmaceuticals, Inc.

Drug Savings

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Treats Disease/Condition

Uses

Used together with diet to treat complications caused by leptin deficiency in people who have lipodystrophy (also called fat redistribution). Lipodystrophy is a problem with the way the body stores fat.

How To Use

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.

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.

Drug Interactions

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.

In Case of Overdose

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

In Case of Missed Dose

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.

Storage

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.