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Myalept

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Myalept

Myalept

Myalept Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Myalept (metreleptin) for Injection is a recombinant human leptin analog used as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Common side effects include headache, low blood sugar, decreased weight, abdominal pain, joint pain, dizziness, ear infection, fatigue, and nausea.

Dosage of Myalept is based on the patient's weight. Myalept may interact with oral contraceptives, warfarin, cyclosporine, or theophylline. Tell your doctor all medications and supplements you use. During pregnancy, Myalept should be used only if prescribed. There is a program that monitors outcomes in women exposed to Myalept during pregnancy. Women who become pregnant during treatment are encouraged to enroll. Breastfeeding is not recommended while taking this drug.

Our Myalept (metreleptin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Myalept FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Open-Label, Single-Arm Study

The safety of MYALEPT was evaluated in 48 patients with generalized lipodystrophy in a single-arm, open-label study [see Clinical Studies]. The median duration of exposure in this trial was 2.7 years with a range of 3.6 months to 10.9 years. The most frequent adverse reactions are summarized in Table 2.

Table 2: Adverse Reactions of 5% or Greater Incidence in Patients with Generalized Lipodystrophy Receiving MYALEPT in an Open-Label, Single-Arm Study

  All Subjects
N=48 (%)
Headache 6 (13)
Hypoglycemia* 6 (13)
Decreased weight 6 (13)
Abdominal pain 5 (10)
Arthralgia 4 (8)
Dizziness 4 (8)
Ear infection 4 (8)
Fatigue 4 (8)
Nausea 4 (8)
Ovarian cyst 4 (8)
Upper respiratory tract infection 4 (8)
Anemia 3 (6)
Back pain 3 (6)
Diarrhea 3 (6)
Paresthesia 3 (6)
Proteinuria 3 (6)
Pyrexia 3 (6)
* Hypoglycemic events were assessed as mild, moderate, severe, or life threatening based on the protocol specified definitions: Mild: Documentation of low plasma glucose values with no symptoms; Moderate: Presence of clinical symptoms requiring ingestion of glucose, self-alleviated; Severe: Presence of neuroglycopenic symptoms requiring assistance from others for alleviation; Life threatening: Loss of consciousness and/or requiring intervention by administration of intravenous glucose or intramuscular glucagon.

In patients with generalized lipodystrophy receiving MYALEPT in this study, less common adverse reactions included injection-site erythema and urticaria (N=2 [4%]).

Six patients (13%) had 7 adverse reactions of hypoglycemia, 6 of which occurred in the setting of concomitant insulin use, with or without oral antihyperglycemic agents.

Two patients (4%) had events of pancreatitis, both of whom had a medical history of pancreatitis.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Anti-metreleptin antibodies were detected in 84% (36/43) of generalized lipodystrophy patients studied in the MYALEPT trials. Total anti-metreleptin antibody titers ranged between 1:5 and 1:1,953,125. The incompleteness of the current immunogenicity database precludes understanding of the magnitude and persistence of the observed anti-drug antibody responses. Anti-metreleptin antibodies with neutralizing activity associated with adverse events consistent with loss of endogenous leptin activity and/or loss of MYALEPT efficacy were observed in 6% (2/33) of the patients with generalized lipodystrophy tested. Adverse events reported in these two patients included severe infections and worsening of metabolic control (increases in HbA1c and/or triglycerides). 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 AstraZeneca at 1-866-216-1526 for testing of clinical samples.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. The immunogenicity assays utilized in clinical trials lacked sensitivity, resulting in potential underestimation of the number of samples positive for anti-metreleptin antibodies with neutralizing activity. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to metreleptin with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Myalept (Metreleptin for Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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