Myalept is an injection you take once a day

Myalept is only available through certified pharmacies that are enrolled in the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Your doctor must be enrolled and certified in the program in order to prescribe Myalept.

Your doctor will start you on a specific dose of Myalept based on your gender and weight. Depending on how well you are doing, your doctor may increase or decrease your dose over time.

Three things to know before you start:

  1. Myalept comes in a powdered form and needs to be mixed with a liquid before injecting. The liquid used to mix Myalept for newborns is different from the liquid used for children and adults. It is very important to follow your doctor’s instructions for mixing Myalept.
  2. Before starting Myalept, a healthcare provider should show you how to inject Myalept for the first time. It is important that a healthcare provider watch your first injection of Myalept.
  3. Myalept needs to be taken once a day, at the same time each day. You should find a time that works for you before starting treatment.

Read the step-by-step Instructions for Use to learn how to mix, store and inject Myalept. These instructions are also included with each Myalept shipment.

Preparing your Myalept® dose

When you are ready to take Myalept, it is important to mix Myalept with the appropriate liquid as prescribed by your doctor, following these guidelines

Baby

Newborn or Infant

Myalept should be mixed with sterile water for injection (preservative-free) (WFI) and used right away. You should throw away any medication not used during each injection. 

Serious side effects including death have happened in newborns or infants who have received the preservative benzyl alcohol. Bacteriostatic water for injection contains benzyl alcohol and it should not be used to mix Myalept for newborns and infants. 

Adult

Older child or adult

Myalept should be mixed with bacteriostatic water for injection (BWFI) and can be used for more than 1 dose for up to 3 days. Mixed Myalept should be stored in the refrigerator and out of the light. You should throw away any medication not used after 3 days. 

For step-by-step instructions on how to prepare your Myalept dose, review the Instructions for Use before each injection.

How do I take Myalept?

Always take medications exactly as instructed by your doctor. Below are some important things to keep in mind while taking Myalept.

Do

DO review the complete Instructions for Use before each injection

DO inject Myalept once a day, at the same time each day

DO inject Myalept at room temperature

DO mix Myalept with the right liquid depending on age

DO inject Myalept in the upper arm, thigh, or abdomen

DO store Myalept in the refrigerator between 36°F and 46°F (2°C and 8°C) and away from light

DO follow the diet recommended by your doctor

Do Not

DO NOT inject Myalept into your muscle or veins

DO NOT take more than your regular daily dosage in a single day

DO NOT take an extra dose or increase the amount of your dose to make up for a missed dose

DO NOT mix Myalept and insulin in the same syringe or vial

DO NOT shake Myalept when mixing

DO NOT freeze Myalept

DO NOT stop taking Myalept without consulting your doctor

DO NOT use if the liquid is cloudy or colored or has particles after mixing

Also taking insulin?

Although Myalept and insulin dose may be taken at the same time, do not inject Myalept and insulin at the same injection site. Once you start taking Myalept, your doctor may adjust your dose of insulin to minimize the risk of low blood sugar (hypoglycemia).

Questions to ask your doctor

Here are some helpful questions that you can ask your doctor before starting Myalept and throughout your treatment.

  • How will I know if Myalept® is working? 
  • How often will I need to have blood tests? 
  • Which tests will I get? 
  • What can I do if I experience side effects? 
  • Will my dose need to be increased over time?
  • What should I be aware of if I am also taking insulin? 
  • Will I need to change dosing of my other medications? 
  • What can I do if the injections are too painful?
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Risk of Neutralizing antibodies and risk of lymphoma.

What is Myalept?

Myalept (metreleptin) is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin (leptin deficiency) in people with generalized lipodystrophy.

  • It is not known if Myalept is safe and effective when used to treat problems (complications) caused by partial lipodystrophy or to treat liver disease, including non-alcoholic steatohepatitis (NASH)
  • Myalept should not be used to treat people with HIV-related lipodystrophy or people with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without signs or symptoms of congenital or acquired generalized lipodystrophy.

Important Safety Information

Myalept is only available through a restricted program called the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Your doctor must be enrolled and certified in the program in order to prescribe Myalept.

Myalept may cause serious side effects, including:

  • risk for developing certain proteins called neutralizing antibodies that may reduce how well your own leptin or Myalept works. Side effects of these antibodies may include infection, problems with blood sugar (including diabetes), or an increase in triglycerides
  • increased risk of a type of blood cancer called lymphoma

You should not take Myalept if you:

  • have general obesity not caused by a congenital leptin deficiency
  • are allergic to metreleptin or any of the ingredients in Myalept.  Symptoms of an allergic reaction include rash, itching (hives), swelling of face, lips, tongue, or throat, problems breathing or swallowing, fainting or dizziness, rapid heartbeat.

Before using Myalept, tell you doctor if you have any medical conditions including if you:

  • have or have had problems with your blood cells, including low blood cell counts (especially your white blood cells), bone marrow, immune system, pancreas, swollen lymph nodes, lymphoma, high blood triglyceride levels, or use insulin or a sulfonylurea
  • are pregnant or plan to become pregnant as it is unknown if Myalept will harm your unborn baby. If you become pregnant while using Myalept, talk to your healthcare provider about registering with a program to collect information about the outcomes of moms and babies exposed to Myalept during pregnancy. You can enroll in the Myalept program by calling 1-855-669-2537
  • are nursing or plan to nurse. You should not nurse while you take Myalept

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Other possible side effects

The most common side effects of Myalept include headache, low blood sugar, decreased weight, and/or abdominal pain.

For newborns and infants, mix Myalept with sterile water for injection (preservative-free) (WFI). Serious side effects including death have happened in newborns or infants who have received the preservative benzyl alcohol.  Bacteriostatic water for injection contains benzyl alcohol and it should not be used to mix Myalept for newborns and infants.

You may get low blood sugar (hypoglycemia) if you take Myalept with other medicines used to lower blood sugar, such as insulin or sulfonylurea. Your doses of these medications may need to be lowered while you use Myalept. Tell your doctor right away if you experience shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, or a jittery feeling because these may be signs of low blood sugar (hypoglycemia).

Myalept may worsen symptoms caused by certain problems in your immune system (autoimmune disorder). Ask your doctor about what symptoms you should watch for that may require further testing.

Talk to your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Myalept. For more information, speak to your doctor or pharmacist. Tell your doctor about all the medications you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.  Take Myalept exactly as your doctor instructs you.

This is the most important information about Myalept. For more detailed information, please see the Medication Guide, Instructions for Use and Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Photographs on this website feature people living with GL and their caregivers.