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Myalept Generic Name & Formulations
Legal Class
Rx
General Description
Metreleptin 11.3mg; per vial; lyophilized pwd for SC inj after reconstitution (with BWFI or WFI).
Pharmacological Class
Recombinant human leptin analog.
How Supplied
Vial—1
Manufacturer
Generic Availability
NO
Myalept Indications
Indications
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.
Myalept Dosage and Administration
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.
Myalept Contraindications
Contraindications
General obesity not associated with congenital leptin deficiency.
Myalept Boxed Warnings
Boxed Warning
Risk of anti-metreleptin antibodies with neutralizing activity. Risk of lymphoma.
Myalept Warnings/Precautions
Warnings/Precautions
Risk of developing anti-metreleptin neutralizing antibodies; test for antibodies if severe infections or loss of efficacy occurs. T-cell lymphoma: 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. Nursing mothers.
REMS
Myalept Pharmacokinetics
See Literature
Myalept Interactions
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.
Myalept Adverse Reactions
Adverse Reactions
Headache, hypoglycemia, decreased weight, abdominal pain; hypersensitivity (discontinue if occurs), lymphomas, progression of autoimmune disorders, possible antibody formation.
Myalept Clinical Trials
See Literature
Myalept Note
Notes
Available only through the Myalept REMS Program. Call (855) 6MYALEPT to enroll.
Myalept Patient Counseling
See Literature
