logo

MYALEPT ® (metreleptin) for injection

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back      |  ---- led    ]
CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION HOW SUPPLIED

CLINICAL PHARMACOLOGY: top of page

Initial U.S. Approval:  2014

Mechanism of Action: Adipocytes store lipids to meet the fuel requirements of non-adipose tissues during fasting. In patients with generalized lipodystrophy, the deficiency of adipose tissue leads to hypertriglyceridemia and ectopic deposition of fat in non-adipose tissues such as liver and muscle, contributing to metabolic abnormalities including insulin resistance. Native leptin is a hormone predominantly secreted by adipose tissue that informs the central nervous system of the status of energy stores in the body. In patients with generalized lipodystrophy, leptin deficiency, resulting from the loss of adipose tissue, contributes to excess caloric intake, which exacerbates the metabolic abnormalities.

MYALEPT (metreleptin) for injection exerts its function by binding to and activating the human leptin receptor (ObR), which belongs to the Class I cytokine family of receptors that signals through the JAK/STAT transduction pathway.

INDICATIONS AND USAGE  top of page


INDICATIONS AND USAGE:
MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. (1)
Limitations of Use:
The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. (1)
The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established. (1)
MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. (1)
MYALEPT is not indicated for use in patients with metabolic disease, without concurrent evidence of generalized lipodystrophy. (1)

DOSAGE AND ADMINISTRATION  top of page


Drug UPDATES:  MYALEPT ® (metreleptin) for injection for subcutaneous use
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

HOW SUPPLIED top of page


HOW SUPPLIED: MYALEPT is supplied as a sterile, white, solid, lyophilized cake of 11.3 mg metreleptin per vial to deliver 5 mg per mL when reconstituted in 2.2 mL of BWFI or WFI.

REFERENCE


Drug UPDATES:  MYALEPT ® (metreleptin) for injection for subcutaneous use
[Drug information  /  PDF]  

Medical Calculators - A thru Z
Lab Values - A thru Z