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Myalept

Generic Name: metreleptin (MET re LEP tin)
Brand Names: Myalept
Myalept (metreleptin) is used to treat complications caused by leptin deficiency in people who have lipodystrophy. Includes Myalept side effects, interactions and indications.
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Drug Information:
Myalept (metreleptin) is used together with diet to treat complications caused by leptin deficiency in people who have lipodystrophy (also called fat redistrIbution). Lipodystrophy (LIP-oh-DIS-tro-fee) is a problem with the way the body stores fat. Myalept is not for use in people who have lipodystrophy caused by taking medicine to treat HIV or AIDS. Myalept may also be used for purposes not listed in this medication guide. In some people, Myalept can trigger an immune response to the medicine, making it less effective or causing certain side effects. Call your doctor if you develop any signs of a new infection (fever, chills, night sweats, weight loss, swollen glands, flu symptoms), or worsening of your lipodystrophy symptoms. If you are diabetic, tell your doctor if you have any changes in your blood sugar levels. Learn more

Myalept Side Effects

Myalept Side Effects

Note: This document contains side effect information about metreleptin. Some of the dosage forms listed on this page may not apply to the brand name Myalept.

In Summary

More frequent 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

Warning

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.

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

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.

Metabolic

Very common (10% or more): Hypoglycemia (13%), decreased weight (13%)

Nervous system

Very common (10% or more): Headache (13%)

Common (1% to 10%): Dizziness, paresthesia

Gastrointestinal

Very common (10% or more): Abdominal pain (10%)

Common (1% to 10%): Nausea, diarrhea, pancreatitis

It has been reported that two patients (4%) had symptoms of pancreatitis. Both had a medical history of pancreatitis.

Immunologic

Frequency not reported: Autoimmune disorder, immunogenicity

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.

Genitourinary

Common (1% to 10%): Ovarian cyst

Hematologic

Common (1% to 10%): Anemia

Hypersensitivity

Common (1% to 10%): Injection-site erythema, urticaria

Frequency not reported: Generalized rash

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain

Other

Common (1% to 10%): Pyrexia, ear infection, fatigue

Renal

Common (1% to 10%): Proteinuria

Respiratory

Common (1% to 10%): Upper respiratory tract infection

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

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Myalept (www.drugs.com/myalept.html).