MYALEPT metreleptin injection powder lyophilized for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METRELEPTIN (UNII: TL60C27RLH) (METRELEPTIN - UNII:TL60C27RLH)

Available from:

Catalent Pharma Solution, LLC

INN (International Name):

METRELEPTIN

Composition:

METRELEPTIN 11.3 mg in 2.2 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Summary of Product characteristics

MYALEPT- METRELEPTIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CATALENT PHARMA SOLUTION, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYALEPT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR MYALEPT.
MYALEPT (METRELEPTIN) FOR INJECTION FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2014
WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING
ACTIVITY AND RISK
OF LYMPHOMA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY HAVE BEEN
IDENTIFIED IN PATIENTS TREATED WITH
MYALEPT. THE CONSEQUENCES ARE NOT WELL CHARACTERIZED BUT COULD INCLUDE
INHIBITION OF ENDOGENOUS
LEPTIN ACTION AND LOSS OF MYALEPT EFFICACY. WORSENING METABOLIC
CONTROL AND/OR SEVERE INFECTION HAVE
BEEN REPORTED. TEST FOR ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING
ACTIVITY IN PATIENTS WITH SEVERE
INFECTIONS OR LOSS OF EFFICACY DURING MYALEPT TREATMENT. CONTACT
AEGERION PHARMACEUTICALS, INC. AT 1-
866-216-1526 FOR NEUTRALIZING ANTIBODY TESTING. ( 4.1), ( 5.1)
T-CELL LYMPHOMA HAS BEEN REPORTED IN PATIENTS WITH ACQUIRED
GENERALIZED LIPODYSTROPHY, BOTH TREATED
AND NOT TREATED WITH MYALEPT. CAREFULLY CONSIDER THE BENEFITS AND
RISKS OF TREATMENT WITH MYALEPT IN
PATIENTS WITH SIGNIFICANT HEMATOLOGIC ABNORMALITIES AND/OR ACQUIRED
GENERALIZED LIPODYSTROPHY. ( 5.2)
MYALEPT IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE
MYALEPT REMS PROGRAM. ( 5.3)
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