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Myalept
metreleptin
Black Box Warnings .
Appropriate Use
restricted distribution program, Myalept REMS program, due to anti-metreleptin antibody and lymphoma risk; prescribers, pharmacies must be certified and enroll at 1-855-669-2537 or www.myaleptrems.com
Anti-Metreleptin Antibodies with Neutralizing Activity Risk
anti-metreleptin antibodies reported in patients treated with metreleptin; may neutralize endogenous leptin activity or decr. metreleptin efficacy, resulting in serious infections and worsening metabolic control; contact 1-866-216-1526 for antibody testing if severe infection signs/symptoms or decr. efficacy
Lymphoma Risk
incr. malignancy risk in patients with acquired generalized lipodystrophy; T-cell lymphoma reported in patients treated with and without metreleptin; weigh risk/benefit in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy
Adult Dosing .
Dosage forms: INJ: 5 mg per mL
Restricted Distribution in US
- [1-855-669-2537 or www.myaleptrems.com for more info]
leptin deficiency
- [<40 kg]
- Dose: individualize dose SC qd; Start: 0.06 mg/kg/dose SC qd, then may adjust by 0.02 mg/kg/day; Max: 0.13 mg/kg/day; Info: for patients with congenital or acquired generalized lipodystrophy; see pkg insert for specific weight-based dose and volume recommendations; taper dose over 1wk to D/C if pancreatitis risk
- [>40 kg, female patients]
- Dose: individualize dose SC qd; Start: 5 mg SC qd, then may adjust by 1.25-2.5 mg/day; Max: 10 mg/day; Info: for patients with congenital or acquired generalized lipodystrophy; taper dose over 1wk to D/C if pancreatitis risk
- [>40 kg, male patients]
- Dose: individualize dose SC qd; Start: 2.5 mg SC qd, then may adjust by 1.25-2.5 mg/day; Max: 10 mg/day; Info: for patients with congenital or acquired generalized lipodystrophy; taper dose over 1wk to D/C if pancreatitis risk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ: 5 mg per mL
Restricted Distribution in US
- [1-855-669-2537 or www.myaleptrems.com for more info]
leptin deficiency
- [<40 kg]
- Dose: individualize dose SC qd; Start: 0.06 mg/kg/dose SC qd, then may adjust by 0.02 mg/kg/day; Max: 0.13 mg/kg/day; Info: for patients with congenital or acquired generalized lipodystrophy; see pkg insert for specific weight-based dose and volume recommendations; taper dose over 1wk to D/C if pancreatitis risk
- [>40 kg, female patients]
- Dose: individualize dose SC qd; Start: 5 mg SC qd, then may adjust by 1.25-2.5 mg/day; Max: 10 mg/day; Info: for patients with congenital or acquired generalized lipodystrophy; taper dose over 1wk to D/C if pancreatitis risk
- [>40 kg, male patients]
- Dose: individualize dose SC qd; Start: 2.5 mg SC qd, then may adjust by 1.25-2.5 mg/day; Max: 10 mg/day; Info: for patients with congenital or acquired generalized lipodystrophy; taper dose over 1wk to D/C if pancreatitis risk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]