Myalept 11.3 mg/2.2mL
metreleptin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Chiesi USA, Inc.
Myalept is a injection, powder, lyophilized, for solution containing metreleptin at 11.3 mg/2.2mL, taken subcutaneous. Manufactured by Chiesi USA, Inc..
Key Facts
- Brand Name
- Myalept
- Generic Name
- metreleptin
- NDC Code (Product)
10122-210- Manufacturer
- Chiesi USA, Inc.
- Strength
- 11.3 mg/2.2mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125390
- Drug Class
- Leptin Analog [EPC]
- Marketing Start
- 03/05/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. ( 1 ) Limitations of Use The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. ( 1 ) The safety and effectiveness of MYALEPT for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established. ( 1 ) MYALEPT is not indicated for use in patients with HIV-related lipodystrophy. ( 1 ) MYALEPT is not indicated for use in patients with metabolic disease, without concurrent evidence of generalized lipodystrophy. ( 1 ) 1.1 Patients with Generalized Lipodystrophy MYALEPT (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Limitations of Use The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established. The safety and effectiveness of MYALEPT for the tr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer as a subcutaneous injection once daily after the lyophilized cake is reconstituted with Bacteriostatic Water for Injection (BWFI) or preservative-free sterile Water for Injection (WFI). ( 2.1 ) The recommended daily dosages are: Body weight 40 kg or less: starting dose 0.06 mg/kg/day, increase or decrease by 0.02 mg/kg to a maximum daily dose of 0.13 mg/kg. ( 2.1 ) Males greater than 40 kg body weight: starting dose 2.5 mg/day, increase or decrease by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day. ( 2.1 ) Females greater than 40 kg body weight: starting dose 5 mg/day, increase or decrease by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day. ( 2.1 ) 2.1 Recommended Dosing See Table 1 for the recommended daily dose and maximum recommended daily dose in adults and pediatric patients. Based on clinical response (e.g., inadequate metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss [especially in pediatric patients]), MYALEPT dosage may be decreased or increased to the maximum dosage listed in Table 1. Table 1: MYALEPT Recommended Dosage Baseline weight Starting daily dose (injection volume) Dose a…
Contraindications
4 CONTRAINDICATIONS General obesity not associated with congenital leptin deficiency. ( 4.1 ) Hypersensitivity to metreleptin. ( 4.2 ) 4.1 General Obesity MYALEPT is contraindicated in patients with general obesity not associated with congenital leptin deficiency. MYALEPT has not been shown to be effective in treating general obesity, and the development of anti-metreleptin antibodies with neutralizing activity has been reported in obese patients treated with MYALEPT [see Warnings and Precautions (5.1) ]. 4.2 Hypersensitivity MYALEPT is contraindicated in patients with prior severe hypersensitivity reactions to metreleptin or to any of the product components. Known hypersensitivity reactions have included anaphylaxis, urticaria and generalized rash [see Warnings and Precautions (5.6) ].
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies were performed. Leptin is a cytokine and may have the potential to alter the formation of cytochrome P450 (CYP450) enzymes. This should be taken into account when prescribing concomitant drugs metabolized by CYP450 (e.g., oral contraceptives and drugs with a narrow therapeutic index). The effect of metreleptin on CYP450 enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted. Upon initiation or discontinuation of MYALEPT, in patients being treated with these types of agents, therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) should be performed and the individual dose of the agent adjusted as needed.
Adverse Reactions
6 ADVERSE REACTIONS Most common in clinical trials (≥10%): headache, hypoglycemia, decreased weight, abdominal pain. ( 5.4 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi Farmaceutici S.p.A. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Open-Label, Single-Arm Study The safety of MYALEPT was evaluated in 48 patients with generalized lipodystrophy in a single-arm, open-label study [see Clinical Studies (14.1) ]. The median duration of exposure in this trial was 2.7 years with a range of 3.6 months to 10.9 years. The most frequent adverse reactions are summarized in Table 3. Table 3: Adverse Reactions of 5% or Greater Incidence in Patients with Generalized Lipodystrophy Receiving MYALEPT in an Open-Label, Single-Arm Study All Subjects N=48 (%) 1. Hypoglycemic events were assessed as mild, moderate, severe, or life threatening based on the protocol specified de…
Frequently Asked Questions
What is Myalept used for?
Myalept contains metreleptin. It is a injection, powder, lyophilized, for solution taken subcutaneous. Consult your doctor for specific uses.
Is Myalept a controlled substance?
Myalept is not classified as a controlled substance by the DEA.
What is the generic name for Myalept?
The generic name for Myalept is metreleptin. There are no other listed brand versions of metreleptin.
What is the NDC code for Myalept 11.3 mg/2.2mL?
The NDC (National Drug Code) for Myalept 11.3 mg/2.2mL is 10122-210, listed by Chiesi USA, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)