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Drug overview for MYALEPT (metreleptin):
Generic name: METRELEPTIN
Drug class: Leptin Hormone Analogs
Therapeutic class: Endocrine
Metreleptin is a recombinant analog of human leptin.
No enhanced Uses information available for this drug.
Generic name: METRELEPTIN
Drug class: Leptin Hormone Analogs
Therapeutic class: Endocrine
Metreleptin is a recombinant analog of human leptin.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for MYALEPT (metreleptin) have been approved by the FDA:
Indications:
Generalized lipodystrophy
Professional Synonyms:
Generalized lipodystrophy (congenital or acquired)
Indications:
Generalized lipodystrophy
Professional Synonyms:
Generalized lipodystrophy (congenital or acquired)
The following dosing information is available for MYALEPT (metreleptin):
No enhanced Dosing information available for this drug.
Metreleptin is administered by subcutaneous injection after reconstitution; the drug should not be administered IV or IM. Recommended sites of injection include the abdomen, thigh, or upper arm. The same area of the body may be used for daily injections; however, injection sites should be rotated with each dose.
Metreleptin should not be administered into the same injection site with other drugs and should not be mixed with insulin in the same syringe or vial. Doses exceeding 1 mL can be administered as 2 injections to minimize potential injection-site discomfort due to injection volume. Metreleptin may be self-administered by the patient or caregiver after appropriate training on dose preparation and subcutaneous injection technique; patients should self-administer their first dose under the supervision of a clinician.
Metreleptin is administered once daily at the same time each day without regard to meals. If a dose is missed, the missed dose should be administered as soon as it is remembered, followed by resumption of the regular schedule the next day; dose should not be doubled or increased to replace a missed dose.
Metreleptin should not be administered into the same injection site with other drugs and should not be mixed with insulin in the same syringe or vial. Doses exceeding 1 mL can be administered as 2 injections to minimize potential injection-site discomfort due to injection volume. Metreleptin may be self-administered by the patient or caregiver after appropriate training on dose preparation and subcutaneous injection technique; patients should self-administer their first dose under the supervision of a clinician.
Metreleptin is administered once daily at the same time each day without regard to meals. If a dose is missed, the missed dose should be administered as soon as it is remembered, followed by resumption of the regular schedule the next day; dose should not be doubled or increased to replace a missed dose.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| MYALEPT 11.3 MG (5 MG/ML) VIAL | Maintenance | Adults inject 1 milliliter (5 mg) by subcutaneous route once daily (same time each day) in the abdomen, thigh,or upper arm rotating injection sites |
No generic dosing information available.
The following drug interaction information is available for MYALEPT (metreleptin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for MYALEPT (metreleptin):
Drug contraindication overview.
General obesity not associated with congenital leptin deficiency; metreleptin is not effective in treating general obesity and patients may develop anti-metreleptin antibodies with neutralizing activity. (See Antibody Formation under Warnings/Precautions: Warnings, in Cautions.) Hypersensitivity to metreleptin or any ingredient in the formulation.
General obesity not associated with congenital leptin deficiency; metreleptin is not effective in treating general obesity and patients may develop anti-metreleptin antibodies with neutralizing activity. (See Antibody Formation under Warnings/Precautions: Warnings, in Cautions.) Hypersensitivity to metreleptin or any ingredient in the formulation.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Obesity |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Malignant lymphoma |
| Myelodysplastic syndrome |
| Neutropenic disorder |
| Pancreatitis |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Autoimmune disease |
| Diabetes mellitus |
| Hypoglycemic disorder |
The following adverse reaction information is available for MYALEPT (metreleptin):
Adverse reaction overview.
Adverse effects reported in at least 5% of patients receiving metreleptin in the principal clinical trial include headache, hypoglycemia, decreased weight, abdominal pain, arthralgia, dizziness, ear infection, fatigue, nausea, ovarian cyst, upper respiratory tract infection, anemia, back pain, diarrhea, paresthesia, proteinuria, and pyrexia.
Adverse effects reported in at least 5% of patients receiving metreleptin in the principal clinical trial include headache, hypoglycemia, decreased weight, abdominal pain, arthralgia, dizziness, ear infection, fatigue, nausea, ovarian cyst, upper respiratory tract infection, anemia, back pain, diarrhea, paresthesia, proteinuria, and pyrexia.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Autoimmune hepatitis Glomerulonephritis Malignant lymphoma Ovarian cyst Pancreatitis |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Headache disorder Hypoglycemic disorder Weight loss |
Anemia Arthralgia Back pain Diarrhea Dizziness Fatigue Fever Infection of ear Nausea Paresthesia Proteinuria Upper respiratory infection |
| Rare/Very Rare |
|---|
|
Injection site hyperpigmentation Injection site inflammation Skin rash Urticaria |
The following precautions are available for MYALEPT (metreleptin):
In the principal clinical trial of metreleptin in patients with generalized lipodystrophy, 73% of the patients were younger than 18 years of age (range: 1-17 years). The median age of all patients in the study at baseline was 15 years. No overall differences in safety or efficacy were observed between these pediatric patients and adult patients.
Metreleptin contains benzyl alcohol when reconstituted with bacteriostatic water for injection. When reconstituted with 2.2 mL of bacteriostatic water for injection, metreleptin contains 1.76
mg of benzyl alcohol per mg of metreleptin or 9 mg of benzyl alcohol per mL of reconstituted solution. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates and low-birth-weight infants. Toxicity appears to have resulted from administration of large amounts (i.e., 100-400 mg/kg daily) of benzyl alcohol in these neonates.
The manufacturer states that usual therapeutic doses of metreleptin deliver substantially lower amounts of benzyl alcohol than those associated with toxicity; however, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Clinicians should consider the combined daily dose of benzyl alcohol from all sources. When prepared for use in neonates and infants, the manufacturer recommends that metreleptin be reconstituted with preservative-free sterile water for injection. (See Reconstitution under Dosage and Administration: Administration.)
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Metreleptin contains benzyl alcohol when reconstituted with bacteriostatic water for injection. When reconstituted with 2.2 mL of bacteriostatic water for injection, metreleptin contains 1.76
mg of benzyl alcohol per mg of metreleptin or 9 mg of benzyl alcohol per mL of reconstituted solution. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates and low-birth-weight infants. Toxicity appears to have resulted from administration of large amounts (i.e., 100-400 mg/kg daily) of benzyl alcohol in these neonates.
The manufacturer states that usual therapeutic doses of metreleptin deliver substantially lower amounts of benzyl alcohol than those associated with toxicity; however, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Clinicians should consider the combined daily dose of benzyl alcohol from all sources. When prepared for use in neonates and infants, the manufacturer recommends that metreleptin be reconstituted with preservative-free sterile water for injection. (See Reconstitution under Dosage and Administration: Administration.)
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) Although there are no adequate and controlled studies to date in humans, metreleptin has been shown to cause prolonged gestation and dystocia in mice resulting in maternal death and decreased survival of offspring when given in dosages approximately equivalent to the maximum recommended human dosage. In an in vitro study, exposure to recombinant leptin caused inhibition of contractility in human myometrial tissue.
No developmental abnormalities were seen in mice exposed during the period of organogenesis to metreleptin at dosages over 7 times the maximum recommended human dosage. The manufacturer has established a program that monitors outcomes in women exposed to metreleptin during pregnancy. Women who become pregnant during metreleptin therapy are encouraged to enroll in the program by calling 855-6MYALEPT (855-669-2537).
No developmental abnormalities were seen in mice exposed during the period of organogenesis to metreleptin at dosages over 7 times the maximum recommended human dosage. The manufacturer has established a program that monitors outcomes in women exposed to metreleptin during pregnancy. Women who become pregnant during metreleptin therapy are encouraged to enroll in the program by calling 855-6MYALEPT (855-669-2537).
It is not known whether metreleptin is distributed into human milk. Endogenous leptin is distributed into human milk. Because of the potential for serious adverse reactions to metreleptin in nursing infants and because of the possibility of anti-metreleptin antibodies distributing into milk, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Clinical studies of metreleptin did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults. In general, dosage of metreleptin in geriatric patients should be initiated at the low end of the dosage range because of the greater frequency of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease or other drug therapy.
The following prioritized warning is available for MYALEPT (metreleptin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for MYALEPT (metreleptin)'s list of indications:
| Generalized lipodystrophy | |
| E88.1 | Lipodystrophy, not elsewhere classified |
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