Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Metreleptin
Drug ID BADD_D01448
Description Metreleptin, a recombinant analog of the human hormone leptin, is an orphan drug used to treat complications of leptin deficiency in people with congenital or acquired lipodystrophy. Affecting less than 500 people worldwide, lipodystrophy is characterized by a lack of adipose tissue, fat deposition in the muscles and liver, and metabolic complications such as hypertriglyceridemia, insulin resistance, diabetes mellitus, and fatty liver disease. These metabolic abnormalities are often aggravated by excessive food intake, which is further aggravated by leptin deficiency, a protein secreted by adipose tissue. Administration of Metreleptin results in improvement of metabolic symptoms including improvements in insulin resistance, reduced HbA1c and fasting glucose, reduced triglycerides, and reductions in food intake. Metreleptin is produced in E. coli and differs from native human leptin by the addition of a methionine residue at its amino terminus. It is administered as a once daily subcutaneous injection. On Feb. 24, 2014, Metreleptin was approved by the FDA for the treatment of complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. Metreleptin is marketed under the brand Myalept® by Aegerion Pharmaceuticals, Inc.
Indications and Usage Metreleptin 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.
Marketing Status approved
ATC Code A16AA07
DrugBank ID DB09046
KEGG ID D05014
MeSH ID C415771
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 76431-210; 43858-712
UNII TL60C27RLH
Synonyms metreleptin | n-methionylleptin | Myalept
Chemical Information
Molecular Formula Not Available
CAS Registry Number 186018-45-1
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Anaemia01.03.02.001--
Arthralgia15.01.02.001--
Back pain15.03.04.005--
Blood triglycerides increased13.12.03.001--Not Available
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Ear infection11.01.05.001; 04.03.01.006--Not Available
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypoglycaemia14.06.03.001; 05.06.03.001--
Infection11.01.08.002--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001--Not Available
Nausea07.01.07.001--
Ovarian cyst21.11.01.002; 16.04.03.001--Not Available
Pancreatitis07.18.01.001--
Paraesthesia23.03.03.094; 17.02.06.005--
Proteinuria20.02.01.011--
Pyrexia08.05.02.003--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urticaria23.04.02.001; 10.01.06.001--
Weight decreased13.15.01.005--
Metabolic disorder14.11.01.001--Not Available
Antibody test13.06.03.009--Not Available
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