MYALEPT should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light until prepared for use. Keep MYALEPT vials in the carton when not in use. 

When reconstituted in Bacteriostatic Water for Injection (BWFI), MYALEPT solution can be used within 3 days when stored in the refrigerator between 36°F and 46°F (2°C and 8°C) and protected from light. Discard unused reconstituted solution after 3 days. Attach the supplied sticker to the vial and enter the discard date. 

After reconstitution, the vials should not be frozen (below 0°C) or shaken vigorously. If the reconstituted product is inadvertently frozen, it should be thrown away. 

No formal pharmacokinetic studies were conducted in patients with renal impairment. Nonclinical data indicate renal clearance is the major route of metreleptin elimination, with no apparent contribution of systemic metabolism or degradation. Hence, the pharmacokinetics of metreleptin may be altered in subjects with renal impairment. 

Healthcare practitioners should instruct patients and caregivers on the proper subcutaneous injection technique with care to avoid intramuscular injection in patients with minimal subcutaneous adipose tissue. Never administer MYALEPT intravenously or intramuscularly. Instruct patients to follow the recommended injection technique:  

• Using a 1-mL syringe with a needle appropriate for subcutaneous injection, withdraw the prescribed dose of MYALEPT reconstituted solution. 
• Remove any large air pockets or large bubbles from the filled syringe prior to administration. Some small bubbles may remain in the syringe.  
• Administer MYALEPT into the subcutaneous tissue of the abdomen, thigh or upper arm. Advise patients to use a different injection site each day when injecting in the same region. After choosing an injection site, pinch the skin and at a 45-degree angle, inject the MYALEPT reconstituted solution subcutaneously. Avoid intramuscular injection, especially in patients with minimal subcutaneous adipose tissue.  
• Doses exceeding 1 mL can be administered as two injections (the total daily dose divided equally) to minimize potential injection-site discomfort due to injection volume. When dividing doses due to volume, doses can be administered one after the other.

Do not mix MYALEPT with insulin. Use a separate syringe for each medication. If MYALEPT and insulin are administered at the same time of day, they may be injected in the same body area using two different injection sites. 

MYALEPT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No adequate and well-controlled studies have been conducted with metreleptin in pregnant women.