Note: This document contains side effect information about metreleptin. Some dosage forms listed on this page may not apply to the brand name Myalept.
Summary
More frequent side effects include: proteinuria and urticaria. Continue reading for a comprehensive list of adverse effects.
Applies to metreleptin: subcutaneous powder for solution.
Warning
Subcutaneous route (Powder for Solution)
Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with metreleptin. The consequences of these neutralizing antibodies 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. Contact Amryt Pharmaceuticals DAC at 1-866-216-1526 for neutralizing antibody testing of clinical samples.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.Because of these risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or metreleptin and the risk for lymphoma, metreleptin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Myalept(TM) REMS Program.
Serious side effects of Myalept
Along with its needed effects, metreleptin (the active ingredient contained in Myalept) 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:
More common
- Anxiety
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chills or fever
- cold sweats
- confusion
- dizziness
- fast heartbeat
- headache
- increased hunger
- nausea
- nervousness
- shakiness
- sore throat
- unusual tiredness or weakness
Less common
- Bloating
- pains in the stomach, side, or abdomen, possibly radiating to the back
- vomiting
Other side effects of Myalept
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:
More common
- Back pain
- diarrhea
- 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.
General
The most frequently reported side effects were headache, hypoglycemia, decreased weight, and abdominal pain.[Ref]
Metabolic
Very common (10% or more): Hypoglycemia (13%), decreased weight (13%)[Ref]
Nervous system
Very common (10% or more): Headache (13%)
Common (1% to 10%): Dizziness, paresthesia[Ref]
Gastrointestinal
It has been reported that two patients (4%) had symptoms of pancreatitis. Both had a medical history of pancreatitis.[Ref]
Very common (10% or more): Abdominal pain (10%)
Common (1% to 10%): Nausea, diarrhea, pancreatitis[Ref]
Immunologic
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]
Genitourinary
Common (1% to 10%): Ovarian cyst
Hematologic
Common (1% to 10%): Anemia[Ref]
Hypersensitivity
Common (1% to 10%): Injection-site erythema, urticaria
Frequency not reported: Generalized rash[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia, back pain[Ref]
Other
Common (1% to 10%): Pyrexia, ear infection, fatigue[Ref]
Renal
Common (1% to 10%): Proteinuria[Ref]
Respiratory
Common (1% to 10%): Upper respiratory tract infection[Ref]
Oncologic
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
