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MYALEPT
Inborn errors of metabolism
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Drug Name:

MYALEPT Rx

Generic Name and Formulations:
Metreleptin 11.3mg; per vial; lyophilized pwd for SC inj after reconstitution (with BWFI or WFI).

Company:
Aegerion Pharmaceuticals

Therapeutic Use:

Indications for MYALEPT:

Adjunct to diet as replacement therapy to treat leptin deficiency complications in patients with congenital or acquired generalized lipodystrophy. Limitations of use: safety and efficacy for treating partial lipodystrophy complications, or liver disease, including nonalcoholic steatohepatitis (NASH) have not been established. Not for use in HIV-related lipodystrophy or metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy.

Adults and Children:

Administer by SC inj same time every day into the abdomen, thigh or upper arm. Rotate inj sites. Dose may be decreased or increased based on clinical response. ≤40kg (males and females): initially 0.06mg/kg once daily; may adjust in 0.02mg/kg increments to max 0.13mg/kg/day. >40kg: initially 2.5mg (males) or 5mg (females) once daily; may adjust in 1.25–2.5mg increments to max 10mg/day. If discontinuing therapy in patients with pancreatitis risk, taper dose over one-week period, monitor triglyceride levels and consider initiating or adjusting dose of lipid-lowering drugs as needed.

Contraindications:

General obesity not associated with congenital leptin deficiency.

Warnings/Precautions:

Risk of developing anti-metreleptin neutralizing antibodies; test for antibodies if severe infections or loss of efficacy occurs. Carefully consider the benefits and risks of treatment in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy. Risk of hypoglycemia; monitor blood glucose in patients on concomitant insulin or insulin secretagogues. Autoimmune disease. Neonates and infants: use preservative-free sterile WFI to reconstitute. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

May affect CYP450 substrates (eg, oral contraceptives). Drugs with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose as needed upon initiation or discontinuation of metreleptin. Concomitant insulin or insulin secretagogues (eg, sulfonylurea); dose adjustments may be needed.

Pharmacological Class:

Recombinant human leptin analog.

Adverse Reactions:

Headache, hypoglycemia, decreased weight, abdominal pain; hypersensitivity (discontinue if occurs), lymphomas, progression of autoimmune disorders, possible antibody formation.

Note:

Available only through the Myalept REMS Program. Call (855) 6MYALEPT to enroll.

REMS:

YES

Generic Availability:

NO

How Supplied:

Vial—1

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