Prescription medicine
Metreleptin Brand names: Myalept
Metreleptin (Myalept) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the metreleptin FDA label on DailyMed (effective March 25, 2024, Chiesi USA, Inc.); the BLA 125390 record on Drugs@FDA; every metreleptin label on DailyMed.
Highlights of the record
FDA label of March 25, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA.
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of MYALEPT efficacy. Severe infection and/or worsening metabolic control have been reported. Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of MYALEPT efficacy during treatment. Contact Chiesi Farmaceutici S.p.A. at 1-866-216-1526 for neutralizing antibody testing of clinical samples [see Contraindications (4.1) and Warnings and Precautions (5.1) ]. T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with MYALEPT. Carefully consider the benefits and risks of treatment with MYALEPT in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy [see Warnings and Precautions (5.2) ]. […]
Used for
From the label: indications and usageMYALEPT 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.
Forms and strengths
- 11.3 mg/2.2ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- February 24, 2014 Myalept, Chiesi Farmaceutici Spa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,244 through July 30, 2026
What is metreleptin used for?
From the label: indications and usageMYALEPT 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. […]
FDA pharmacologic class: Leptin Analog.
Source: FDA drug label (Myalept), Chiesi USA, Inc., effective March 25, 2024 (SPL set d3b50bbd-140b-425c-b5ec-d4682aad62bc), via openFDA; the full label on DailyMed
What does the patient leaflet for metreleptin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about MYALEPT?MYALEPT may cause serious side effects, including: risk for loss of endogenous leptin activity or loss of MYALEPT efficacy due to neutralizing antibodies. Some people who use MYALEPT make antibodies in their blood that may reduce how well the leptin in your body (endogenous) works or how well MYALEPT works. Side effects may include: infection problems with blood sugar, including diabetes an increase in the amount of fat in your blood (triglycerides) lymphoma (a type of blood cancer). There may be an increased risk of getting lymphoma when you use MYALEPT. MYALEPT is only available through a restricted program called the MYALEPT Risk Evaluation and Mitigation Strategy (REMS) Program. For more information about the MYALEPT REMS Program go to www.myaleptrems.com or call 1-855-669-2537.
From the patient leaflet: How should I store MYALEPT?Store MYALEPT in the refrigerator between 36°F to 46°F (2°C to 8°C). KEEP MYALEPT vials in their carton and out of the light. Do not freeze MYALEPT. Do not use MYALEPT past the expiration date printed on the vial. Do not use MYALEPT if the white powder in the vial is discolored. After mixing, the MYALEPT liquid in the vial should be clear and colorless. Do not use MYALEPT if it is colored or cloudy, or has any lumps or particles in it. Throw the vial away and get a new one. After mixing, do not freeze or shake MYALEPT. MYALEPT mixed with BWFI: MYALEPT can be used for more than 1 dose for up to 3 days when stored in the refrigerator between 36°F to 46°F (2°C to 8°C) and out of the light. Throw away any unused MYALEPT after 3 days. MYALEPT mixed with WFI: Should be used right away. Throw away any unused MYALEPT, it cannot be saved for later use. […]
Source: FDA drug label (Myalept), Chiesi USA, Inc., effective March 25, 2024 (SPL set d3b50bbd-140b-425c-b5ec-d4682aad62bc), via openFDA; the full label on DailyMed
Is there a generic for metreleptin (Myalept)?
No generic metreleptin is approved (Drugs@FDA, October 8, 2026).
- 2014 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the metreleptin label say about other medicines?
The metreleptin label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | 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. |
| Theophylline | drug interactions | 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. |
| Warfarin | drug interactions | 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. |
Source: FDA drug label (Myalept), Chiesi USA, Inc., effective March 25, 2024 (SPL set d3b50bbd-140b-425c-b5ec-d4682aad62bc), via openFDA; the full label on DailyMed
What do FAERS reports show for metreleptin?
The FDA Adverse Event Reporting System holds 1,244 reports that list metreleptin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 69 are coded as a death and 360 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Metreleptin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other