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Metreleptin Side Effects

In Summary

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 solution

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:

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

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

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]

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]

Immunologic

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]

Frequency not reported: Autoimmune disorder, immunogenicity[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

Frequency not reported: T-cell lymphoma, anaplastic large cell lymphoma

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.

References

1. "Product Information. Myalept (metreleptin)." Bristol-Myers Squibb, Princeton, NJ.

Some side effects of metreleptin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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