(Drug Name) (Drug Form) (Drug Strength)
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MYALEPT: Lyophilisate for solution for injection (11.3mg)

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What is this Medicine?

Metreleptin (met re LEP tin) is a human leptin analog. It is used to treat the symptoms of leptin deficiency in patients with congential or acquired generalized lipodystrophy. This medicine is not a cure.

In-Depth Information

MYALEPT 11.3mg Powder for Injection

NDC: 667800310
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Generalized Lipodystrophy

Storage Information
Refrigerated product should reach room temperature before administration
Refrigerate (between 36 and 46 degrees F)
Protect from light
Discard product if it contains particulate matter, is cloudy, or discolored
Do not freeze
Store in outer carton when not in use
MYALEPT 11.3mg Powder for Injection

Reported Side Effects for MYALEPT 11.3mg Powder for Injection

Injection Site Reaction Incidence:
4.0%*
Severity: MILD
Onset: RAPID
Inflamed Pancreas Incidence:
4.0%*
Severity: SEVERE
Onset: DELAYED
Hives Incidence:
4.0%*
Severity: MILD
Onset: RAPID
Paresthesias Incidence:
6.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
6.0%*
Severity: MILD
Onset: DELAYED
Protein In The Urine Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Fever Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Anemia Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Infection Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Stomach Pain Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Antibody Formation Incidence:
>10.0%*
Severity: MODERATE
Onset: DELAYED
Low Blood Sugar Incidence:
13.0%*
Severity: MODERATE
Onset: EARLY
Headache Incidence:
13.0%*
Severity: MILD
Onset: EARLY
Weight Loss Incidence:
13.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


Learning More About
Visit the Drug Summary page where you can:
  • Get answers to Frequently Asked Questions (FAQs)
  • Find other class related drugs
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Patient Experiences with MYALEPT

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