Frequently Asked Questions

Q
Is Myalept approved by the FDA?
A

In 2014, Myalept was approved by the FDA to be used along with a doctor-recommended diet to treat complications of not having enough leptin in people with generalized lipodystrophy (GL). It is not known if Myalept is safe and effective when used to treat problems 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.

 
Q
What diet should I follow while taking Myalept?
A

Your doctor is the best resource for nutrition recommendations. Work with your doctor to develop a nutrition plan that is best for you.

 
Q
Can I get Myalept at my local pharmacy where I get all my other prescriptions?
A

Myalept is not available at local pharmacies. It is a prescription medication available only through certified pharmacies that are enrolled in the Myalept REMS Program. Myalept is delivered right to your door through one of our Specialty Pharmacy Partners.

 
Q
How much does Myalept cost?
A

Once your doctor has made the decision to prescribe Myalept, your Specialty Pharmacy will do a benefit verification with your insurance company to identify your out-of-pocket costs related to Myalept. Financial assistance is available to eligible patients to help cover these out-of-pocket costs. Call ByMySide at 1-855-6MYALEPT (1-855-669-2537) to learn about your options including the ByMySide Copay Program,* which covers costs of copayments or coinsurance at 100%, up to the program maximum, for eligible patients.

 
Q
If I have questions about mixing, injecting, or storing Myalept, where can I get answers?
A

Please review the complete Instructions for Use included in each Myalept shipment. If you have trouble finding what you need, you can also contact ByMySide for assistance. You can schedule an in-person injection training session, at no cost to you, with a ByMySide registered nurse. The nurse will come to your home or to your doctor’s office to teach you how to mix and inject Myalept.

 
Q
Are there smaller needles available for injecting my child?
A

Ask your doctor about prescribing the smallest possible needle to use for injecting Myalept to your child. Also, a ByMySide registered nurse can come directly to your home or doctor’s office to provide training, at no cost to you, on how to properly inject Myalept.

 
Q
Can I stop taking Myalept at any time?
A

Do not stop taking Myalept without consulting with your doctor. Stopping Myalept suddenly may cause a serious problem with your pancreas (pancreatitis) and very high triglycerides. You should take Myalept once a day every day unless otherwise directed by your doctor.

 
Q
How should I travel with Myalept?
A

Myalept is portable, as long as you have a cool place to store it. Myalept should be stored between 36°F and 46°F (2°C and 8°C). Contact a ByMySide Coordinator at 1-855-6MYALEPT (1-855-669-2537) to learn how to travel with your Myalept.

 

*The ByMySide Copay Program is not valid for prescriptions eligible to be reimbursed, in whole or in part, by state or federally funded healthcare programs such as Medicaid, Medicare, Tricare, VA/DOD, or any state prescription drug assistance programs. Other eligibility requirements may apply. Amryt reserves the right to discontinue or modify the ByMySide Copay Program at any time. If you are not eligible to participate in the ByMySide CoPay Program, ByMySide may refer you to third-party patient assistance programs that may be able to help with your out-of-pocket costs.

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.