MYALEPT- metreleptin injection, powder, lyophilized, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Metreleptin (UNII: TL60C27RLH) (Metreleptin - UNII:TL60C27RLH)

متاح من:

Amryt Pharmaceuticals DAC

INN (الاسم الدولي):

Metreleptin

تركيب:

Metreleptin 11.3 mg in 2.2 mL

طريقة التعاطي:

SUBCUTANEOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

MYALEPT (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Limitations of Use - The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. - The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established. - MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. - MYALEPT is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy. MYALEPT is contraindicated in patients with general obesity not associated with congenital leptin deficiency. MYALEPT has not been shown to be effective in treating general obesity, and the development of anti-metreleptin antibodi

الوضع إذن:

Biologic Licensing Application

نشرة المعلومات

Amryt Pharmaceuticals DAC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Approved 09/2020
MYALEPT® (MAI-uh-lept)
(metreleptin)
for injection, for subcutaneous use
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.
MYALEPT is only available through a restricted program called the
MYALEPT Risk Evaluation and
Mitigation Strategy (REMS) Program. For more information about the
MYALEPT REMS Program go to
www.myaleptrems.com or call 1-855-669-2537.
What is MYALEPT?
MYALEPT is a prescription medicine used with a diet recommended by
your healthcare provider to treat
problems caused by not having enough leptin in your body (leptin
deficiency) in people with congenital or
acquired generalized lipodystrophy.
•
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
Do not use MYALEPT if you:
•
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 i

خصائص المنتج

MYALEPT- METRELEPTIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AMRYT PHARMACEUTICALS DAC
----------
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 AMRYT PHARMACEUTICALS DAC
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 for use in pat