Metreleptin Side Effects
Medically reviewed by Drugs.com. Last updated on March 29, 2020.
More frequently reported side effects include: proteinuria and urticaria. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to metreleptin: subcutaneous powder for solution
Subcutaneous route (Powder for Solution)
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin. The consequences are not well characterized but could include inhibition of endogenous leptin action and/or loss of metreleptin 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 metreleptin efficacy during treatment. T-cell lymphoma has been reported in patients with acquired generalized lipodystrophy, both treated and not treated with metreleptin. Carefully consider the benefits and risks of treatment with metreleptin in patients with significant hematologic abnormalities and/or acquired generalized lipodystrophy. Metreleptin is available only through a restricted program called the Myalept(TM) REMS Program.
Side effects requiring immediate medical attention
Along with its needed effects, metreleptin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking metreleptin:
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chills or fever
- cold sweats
- fast heartbeat
- increased hunger
- sore throat
- unusual tiredness or weakness
Side effects not requiring immediate medical attention
Some side effects of metreleptin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Back pain
- ear drainage
- earache or pain in the ear
- muscle pain or stiffness
- pain in the joints
- weight loss
For Healthcare Professionals
Applies to metreleptin: subcutaneous powder for injection
Very common (10% or more): Hypoglycemia (13%), decreased weight (13%)[Ref]
Very common (10% or more): Headache (13%)
Common (1% to 10%): Dizziness, paresthesia[Ref]
Very common (10% or more): Abdominal pain (10%)
Common (1% to 10%): Nausea, diarrhea, pancreatitis[Ref]
Frequency not reported: Autoimmune disorder, immunogenicity[Ref]
In vitro neutralizing activity anti-metreleptin antibodies were identified in 2 patients (n=33) with generalized lipodystrophy who showed severe infections and worsening metabolic control (increases in HbA1c and/or triglycerides). Three patients with anti-metreleptin antibodies without lipodystrophy showed excessive weight gain, and/or development of glucose intolerance or diabetes.
In clinical trials, anti-metreleptin antibodies were detected in 36 of 43 generalized lipodystrophy patients, with titers ranging from 1:5 to 1:1,953, 125; however, these numbers may be misleading as detection of antibody formation is highly dependent on the sensitivity and specificity of the assay (the assays utilized in clinical trials lacked sensitivity), handling of the sample, concomitant drugs, and underlying disease. Due to incompleteness of the immunogenicity data, the clinical significance and the magnitude and persistence of the anti-drug responses are not well characterized.[Ref]
Common (1% to 10%): Ovarian cyst
Common (1% to 10%): Anemia[Ref]
Frequency not reported: Generalized rash[Ref]
Common (1% to 10%): Arthralgia, back pain[Ref]
Common (1% to 10%): Pyrexia, ear infection, fatigue[Ref]
Common (1% to 10%): Proteinuria[Ref]
Three cases of T-cell lymphoma were reported among patients with acquired generalized lipodystrophy; 2 patients diagnosed with peripheral T-cell lymphoma during treatment had immunodeficiency and significant hematologic abnormalities including severe bone marrow abnormalities prior to starting treatment. Anaplastic large cell lymphoma was reported in 1 patient receiving this drug who did not have hematologic abnormalities before treatment.
Frequency not reported: T-cell lymphoma, anaplastic large cell lymphoma
1. "Product Information. Myalept (metreleptin)." Bristol-Myers Squibb, Princeton, NJ.
More about metreleptin
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- Drug class: miscellaneous metabolic agents
- Other brands
Related treatment guides
Some side effects may not be reported. You may report them to the FDA.