What is the most important information I should know about MYALEPT?
MYALEPT may cause serious side effects, including:

• risk for loss of endogenous leptin activity or loss of MYALEPT efficacy due to neutralizing antibodies.
  Some people who use MYALEPT make antibodies in their blood that may reduce how well the leptin in your body (endogenous) works or how well MYALEPT works. Side effects may include:
  • infection
  • problems with blood sugar, including diabetes
  • an increase in the amount of fat in your blood (triglycerides)
• lymphoma (a type of blood cancer). There may be an increased risk of getting lymphoma when you use MYALEPT.

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

• have general obesity that is not caused by a congenital leptin deficiency.
• are allergic to metreleptin or any of the ingredients in MYALEPT. See the end of this Medication Guide for a complete list of ingredients in MYALEPT.
  Talk to your healthcare provider right away if you have any symptoms of an allergic reaction including a rash or itching (hives).
  Symptoms of a severe allergic reaction may include:
  • swelling of your face, lips, tongue, or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat

• have or have had problems with your blood cells including low blood cell counts, especially white blood cells
• have or have had problems with your bone marrow
• have or have had swollen lymph nodes (lymphadenopathy)
• have or have had lymphoma
• use insulin or a sulfonylurea
• have or have had problems with your immune system (autoimmune disease)
• have or have had problems with your pancreas (pancreatitis)
• have high blood triglyceride levels
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known 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 breastfeeding or plan to breastfeed. It is not known if MYALEPT passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking MYALEPT.

• See the Instructions for Use that come with MYALEPT for detailed instructions on using MYALEPT the right way.
• Use MYALEPT exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much MYALEPT to use and when to use it. Do not change your dose unless your healthcare provider tells you to.
  • Do not suddenly stop using MYALEPT. Stopping MYALEPT suddenly may cause a serious problem with your pancreas (pancreatitis) and very high triglycerides.
  • If your healthcare provider decides that you should stop using MYALEPT, your healthcare provider should slowly decrease your dose (taper) over 1 week.
• MYALEPT is injected 1 time a day at the same time each day.
• MYALEPT can be used with or without food.
• If you miss a dose of MYALEPT, take it as soon as you remember. Take your regular dose the next day at your normal time. Do not take more than your regular daily dose 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. Although MYALEPT and insulin doses may be given at the same time, do not inject MYALEPT and insulin in the same injection site.
• When MYALEPT is used in newborns or infants, your healthcare provider will tell you if MYALEPT should be mixed with a liquid called sterile water for injection (WFI) (preservative-free). For older children and adults, bacteriostatic water for injection (BWFI) may be used.
• MYALEPT is given as an injection under the skin (subcutaneous) of your stomach (abdomen), thigh, or upper arm. Do not inject MYALEPT into a vein or muscle.

• autoimmunity. People who have or have had certain problems with their immune system (autoimmune disease) may have worsening of their symptoms with MYALEPT. Talk to your healthcare provider about what symptoms you should watch for that would warrant further testing.
• allergic reactions (hypersensitivity). Allergic reactions can happen in people who use MYALEPT. Talk to your healthcare provider right away if you have any symptom of an allergic reaction. See "
• benzyl alcohol toxicity. Serious side effects including death have happened in newborns or infants who have received the preservative benzyl alcohol. MYALEPT, when mixed with a liquid called bacteriostatic water for injection (BWFI), contains benzyl alcohol. MYALEPT, when mixed with a liquid called sterile water for injection (WFI) (preservative-free), contains no benzyl alcohol. When MYALEPT is used in newborns or infants, MYALEPT should be mixed with sterile water for injection (WFI).

• headache
• low blood sugar (hypoglycemia)
• decreased weight
• abdominal pain

• Store MYALEPT in the refrigerator between 36°F to 46°F (2°C to 8°C).
• KEEP MYALEPT vials in their carton and out of the light.
• Do not freeze MYALEPT.
• Do not use MYALEPT past the expiration date printed on the vial.
• Do not use MYALEPT if the white powder in the vial is discolored.
• After mixing, the MYALEPT liquid in the vial should be clear and colorless. Do not use MYALEPT if it is colored or cloudy, or has any lumps or particles in it. Throw the vial away and get a new one.
• After mixing, do not freeze or shake MYALEPT.
• MYALEPT mixed with BWFI:
  • MYALEPT can be used for more than 1 dose for up to 3 days when stored in the refrigerator between 36°F to 46°F (2°C to 8°C) and out of the light. Throw away any unused MYALEPT after 3 days.
• MYALEPT mixed with WFI:
  • Should be used right away. Throw away any unused MYALEPT, it cannot be saved for later use.