| 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 |
The most common adverse events reported for metreleptin use have been headache, hypoglycemia, weight loss, and abdominal pain. A boxed warning states that anti-metreleptin antibodies, serious infections, and worsening metabolic control have been reported in patients taking the drug, and that some patients with acquired generalized lipodystrophy taking metreleptin have developed T-cell lymphoma. Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin which can lead to inhibition of endogenous leptin action and loss of drug efficacy. As part of a Risk Evaluation and Mitigation Strategy (REMS), the FDA has required healthcare providers to be trained in the use of metreleptin before prescribing it and to attest that patients for whom they prescribe metreleptin have a labeled indication for the drug. Metreleptin is classified as category C (no adequate studies in women) for use during pregnancy.
|
| Marketing Status |
Prescription |
| ATC Code |
A16AA07 |
| DrugBank ID |
DB09046
|
| KEGG ID |
D05014
|
| MeSH ID |
C415771
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
Not Available
|
| NDC Product Code |
43858-712; 76431-210 |
| Synonyms |
metreleptin | n-methionylleptin | Myalept |
|
| Chemical Information |
| Molecular Formula |
Not Available |
| CAS Registry Number |
186018-45-1 |
| SMILES |
Not Available |
| Chemical Structure |
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|
| ADR Related Proteins Induced by Drug |
| ADR Term |
Protein Name |
UniProt AC |
TTD Target ID |
PMID |
| Not Available | Not Available | Not Available | Not Available | Not Available |
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| ADRs Induced by Drug |
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