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Myalept

Generic Name: metreleptin (MET-re-LEP-tin)
Brand Name: Myalept

Some people who use Myalept make antibodies in their blood. These antibodies may decrease how well a substance (leptin) in your body works or how well Myalept works. Side effects may also happen. These could include infection, problems with blood sugar (eg, diabetes), and an increase in how much fat is in your blood (triglycerides). Call your doctor right away if you have symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; drowsiness; flushing; rapid breathing; fruit-like breath odor) or an infection (eg, fever, chills, sore throat).

A certain type of blood cancer (T-cell lymphoma) has happened in people with this condition. This has happened in people both treated and not treated with Myalept. Tell your doctor if you have ever had any immune system or bone marrow problems. Discuss any questions or concerns with your doctor.

You can only get Myalept through a special program called the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Make sure you understand all warnings and instructions for using Myalept. Ask your doctor or pharmacist if you have any questions about this program or the use of Myalept.


Myalept is used for:

Treating problems caused by not having enough of a certain hormone (leptin) in your body. It is only approved for use in people with congenital or acquired generalized lipodystrophy. It is used along with a certain diet.

Myalept is a leptin analog. It works by replacing leptin in patients who do not have enough in their body. Leptin regulates food intake and body weight.

Do NOT use Myalept if:

  • you are allergic to any ingredient in Myalept
  • you are treating a condition not caused by not having enough leptin in your body

Contact your doctor or health care provider right away if any of these apply to you.

Before using Myalept:

Some medical conditions may interact with Myalept. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have high blood triglyceride levels
  • if you have a history of pancreatitis, bone marrow problems (eg, low blood cell counts, lymphoma), immune system problems (eg, an autoimmune disease), or swollen glands
  • if you are taking cyclosporine, theophylline, or warfarin

Some MEDICINES MAY INTERACT with Myalept. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Insulin, sulfonylureas (eg, glipizide), or other medicines that can lower blood sugar because the risk of low blood sugar may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Myalept may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Myalept:

Use Myalept as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Myalept comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Myalept refilled.
  • Myalept is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Myalept at home, a health care provider will teach you how to use it. Be sure you understand how to use Myalept. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Myalept will need to be mixed before giving it. A few fluids can be used to mix Myalept. Be sure you know which fluid to use, how long the product is good after mixing it, and how to store it after mixing.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
  • Inject into the stomach, thigh, or upper arm.
  • Rotate injection sites with each dose of Myalept. This will help to decrease the risk of skin damage at the injection site.
  • Myalept can be given at any time of the day, with or without food. Use Myalept at the same time each day.
  • Do not mix Myalept with insulin. Use a different syringe for each medicine.
  • Do not use Myalept if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Myalept, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Myalept.

Important safety information:

  • Follow the diet program given to you by your health care provider.
  • Do not suddenly stop using Myalept without checking with your doctor. You may have an increased risk of pancreatitis and very high blood triglycerides. If you need to stop Myalept, your doctor may need to gradually lower your dose and watch you closely.
  • People who have had an autoimmune disease may have worsening of their symptoms. Discuss any questions or concerns with your doctor.
  • Some fluids used to mix Myalept contain benzyl alcohol. Do not use products with benzyl alcohol in NEWBORNS or INFANTS. It may cause serious and sometimes fatal side effects. If you have questions, check with your doctor or pharmacist.
  • Diabetes patients - The risk of low blood sugar levels may be increased if you take Myalept with insulin or other medicines that lower blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • LAB TESTS may be performed while you use Myalept. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Myalept while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Myalept.

Possible side effects of Myalept:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; stomach pain; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; fainting; severe dizziness; fast heartbeat); burning, numbness, or tingling; severe or persistent stomach pain; symptoms of low blood sugar (eg, increased sweating, weakness, tremors, dizziness, fainting, drowsiness, headache, chills, fast heartbeat, vision changes, increased hunger); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Myalept:

Before preparing for use, store Myalept in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light by storing unused vials in the carton. Once mixed, be sure you know how long the product is good for. Keep Myalept out of the reach of children and away from pets.

General information:

  • If you have any questions about Myalept, please talk with your doctor, pharmacist, or other health care provider.
  • Myalept is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Myalept or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Myalept. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Myalept. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Myalept.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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