Taking Myalept

Myalept is a Once-Daily Injection

Myalept is a prescription medicine 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.

Before you start, here are 3 things to know:

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, your doctor should show you how to inject Myalept for the first time. It is important that your doctor 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.

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.

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.

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.

Once you start taking Myalept, your doctor may adjust your dose of insulin to help reduce the risk of low blood sugar (hypoglycemia). Make sure to review the complete Instructions for Use before each injection.

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 vary (rotate) the site where you give the injection
DON’T
  • 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

Important Safety Information

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.

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:

You should not take Myalept if you:

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

Other possible side effects

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

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).

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.

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 doctor 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.

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.

This is the most important information about Myalept. For more detailed information, please see the patient Medication Guide and full Prescribing Information including Boxed Warning.