Generic Name and Formulations:
Metreleptin 11.3mg; per vial; lyophilized pwd for SC inj after reconstitution (with BWFI or WFI).
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.
General obesity not associated with congenital leptin deficiency.
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 (Cat.C). Nursing mothers: not recommended.
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.
Recombinant human leptin analog.
Headache, hypoglycemia, decreased weight, abdominal pain; hypersensitivity (discontinue if occurs), lymphomas, progression of autoimmune disorders, possible antibody formation.
Available only through the Myalept REMS Program. Call (855) 6MYALEPT to enroll.
Sign Up for Free e-newsletters
- Managing Chemo Brain in Pediatric Survivors of Childhood Cancer
- Aggressive Therapy Provides No Additional Advantage in Metastatic Prostate Cancer
- Excretion of Volatile Organic Compounds Higher in AYAs Using Vaping Products
- FDA, ASHP Actions to Prevent or Manage Chemotherapy Drug Shortages
- Risk for Cardiovascular Disease Higher in Survivors of Testicular Cancer
- Various Aspects of Palliative Care Focus Associated With Different Outcomes In Cancer
- Cost vs Benefits: The Controversy Over Proton Beam Radiotherapy
- Patient Expectations at Odds With Actual Outcomes for Radiotherapy in Breast Cancer
- Patients Desire More Online Tools and Access
- Metformin Plus Ruxolitinib: A Potential Therapeutic Alternative for Myeloproliferative Neoplasms
- Sexual Quality of Life Decreased During, After Chemotherapy for Digestive Cancers
- CHEMO-SUPPORT: A Nursing Intervention to Relieve Chemotherapy Symptom Burden
- Approach and Management of Checkpoint Inhibitor-related Immune Hepatitis
- Revised AJCC8 Demonstrates Superior Tumor Classification for HNCSCC
- Oral Androgen Receptor Inhibitor Granted FDA Approval for Nonmetastatic CRPC
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|