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Myalept Dosing Information

Myalept Is a Once-Daily Subcutaneous Injection

Myalept should be administered once daily at the same time every day, regardless of the timing of meals¹
If a dose is missed, patients should be instructed to administer the dose as soon as noticed, and resume the normal dosing schedule the next day¹

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Recommended daily dose of Myalept for pediatric and adult patients¹

Baseline weight

≤40 kg
(males and females)

Males >40 kg

Females >40 kg

Starting daily dose (injection volume)

0.06 mg/kg 
(0.012 mL/kg)

2.5 mg (0.5 mL)

5 mg
(1 mL)

Dose adjustments (injection volume)

0.02 mg/kg 
(0.004 mL/kg)

1.25 mg-2.5 mg  
(0.25 mL-0.5 mL)

Maximum daily dose (injection volume)

0.13 mg/kg 
(0.026 mL/kg)

10 mg (2 mL)

Based on clinical response (eg, inadequate metabolic control) or other considerations (eg, tolerability issues, excessive weight loss [especially in pediatric patients]), the Myalept dose may be decreased or increased to the maximum dose listed in the table above.¹

For patients weighing less than 40 kg, the exact dose must be calculated

Use the chart below to find the correct dose of Myalept.

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Example dosing for patients ≤40 kg¹

Weight

5 kg

10 kg

15 kg

20 kg

25 kg

35 kg

40 kg

Starting Dose

0.30 mg (0.06 mL or 6 Units)

0.60 mg (0.12 mL or 12 Units)

0.90 mg (0.18 mL or 18 Units)

1.2 mg (0.24 mL or 24 Units)

1.5 mg (0.3 mL or 30 Units)

1.8 mg (0.36 mL or 36 Units)

2.1 mg (0.42 mL or 42 Units)

2.4 mg (0.48 mL or 48 Units)

Weight

5 kg

10 kg

15 kg

20 kg

25 kg

35 kg

40 kg

Dose Adjustment

0.10 mg (0.02 mL or 2 Units)

0.20 mg (0.04 mL or 4 Units)

0.30 mg (0.06 mL or 6 Units)

0.40 mg (0.08 mL or 8 Units)

0.50 mg (0.1 mL or 10 Units)

0.60 mg (0.12 mL or 12 Units)

0.70 mg (0.14 mL or 14 Units)

0.80 mg (0.16 mL or 16 Units)

Weight

5 kg

10 kg

15 kg

20 kg

25 kg

35 kg

40 kg

Maximum Dose

0.65 mg (0.13 mL or 13 Units)

1.3 mg (0.26 mL or 26 Units)

1.95 mg (0.39 mL or 39 Units)

2.6 mg (0.52 mL or 52 Units)

3.25 mg (0.65 mL or 65 Units)

3.9 mg (0.78 mL or 78 Units)

4.55 mg (0.91 mL or 91 Units)

5.2 mg (1.03 mL or 103 Units)

See Instructions for Use for more information on the conversion of a Myalept dose to a unit measurement for injection.

Myalept Dosage Adjustments and Discontinuation

In patients at risk for hypoglycemia

Dosage adjustments, including possible large reductions, of insulin or insulin secretagogue may be necessary in some patients to minimize the risk of hypoglycemia¹
When treating patients concomitantly with Myalept and insulin therapy, close monitoring of blood glucose levels is recommended¹

In patients at risk for pancreatitis

Tapering of the dose over a 1-week period is recommended¹
During tapering, monitor triglyceride levels and consider initiating or adjusting the dose of lipid-lowering medications as needed¹

Myalept Storage and Preparation

HCPs should support patient and caregiver training

Prior to self-use, patients and caregivers should prepare and administer the first dose of Myalept under the supervision of a qualified healthcare professional.¹

Myalept storage and reconstitution

Healthcare professionals should instruct patients to store the vials of lyophilized powder in the refrigerator as soon as they receive them¹
Myalept can be reconstituted aseptically with sterile Water for Injection (WFI) or Bacteriostatic Water for Injection (BWFI)¹

Myalept reconstitution and storage guidelines¹

Diluent for reconstitution

2.2 mL of sterile WFI

Storage guidelines and recommendations

For use in neonates and infants, reconstitute with preservative-free sterile WFI. When reconstituted with sterile WFI, Myalept should be administered immediately
Unused reconstituted solution cannot be saved for later use and should be discarded

Diluent for reconstitution

2.2 mL of sterile BWFI USP (0.9% benzyl alcohol)

Storage guidelines and recommendations

For use in pediatric and adult patients, reconstitute with BWFI. When reconstituted with BWFI, Myalept solution can be used within 3 days when stored in the refrigerator between 36° F and 46° F (2° C and 8° C) and protected from light
Discard unused reconstituted solution after 3 days. Attach the supplied sticker to the vial and enter the discard date

Myalept Administration

Myalept is given as a subcutaneous injection

Healthcare professionals should instruct patients and caregivers on the proper subcutaneous injection technique, using care to avoid intramuscular injection in patients with minimal subcutaneous adipose tissue.¹

Refer to the image below for approved subcutaneous injection sites for Myalept administration.

Diagram showing approved Myalept injection sites on the front and back of the body: stomach, thigh, and upper arm

Comprehensive Support Is Available for Your Patients

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Reference: 1. Myalept^® (metreleptin) for injection for subcutaneous use [package insert]. Chiesi USA; 2024.

Important Safety Information

INDICATION: Myalept^® (metreleptin) for injection is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

LIMITATIONS OF USE: The safety and effectiveness of Myalept for the treatment of complications of partial lipodystrophy or for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established.

Myalept is not indicated for use in patients with HIV-related lipodystrophy. Myalept is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of generalized lipodystrophy.

WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA

Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with Myalept. The consequences of these neutralizing antibodies are not well characterized but could include inhibition of endogenous leptin action and/or loss of Myalept 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 Myalept efficacy during treatment. Contact Chiesi Farmaceutici S.p.A. 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 Myalept. Carefully consider the benefits and risks of treatment with Myalept 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 Myalept and the risk for lymphoma, Myalept is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Myalept REMS PROGRAM.

CONTRAINDICATIONS: Myalept is contraindicated in general obesity not associated with congenital leptin deficiency. Myalept has not been shown to be effective in treating general obesity. The development of anti-metreleptin neutralizing antibodies have been reported in obese patients treated with Myalept. Myalept is contraindicated in patients with prior severe hypersensitivity reactions to metreleptin or to any of its components.

WARNINGS AND PRECAUTIONS: A dose adjustment, including possible large reductions, of insulin or insulin secretagogue may be necessary in some patients to minimize risk of hypoglycemia. Closely monitor blood glucose in patients on concomitant insulin, especially those on high doses, or insulin secretagogue.

Cases of progression of autoimmune hepatitis and membranoproliferative glomerulonephritis (associated with massive proteinuria and renal failure) were observed in some patients with acquired generalized lipodystrophy treated with Myalept. A causal relationship between Myalept and the development and/or progression of autoimmune disease has not been established. Carefully consider the benefits and risks of Myalept treatment in patients with autoimmune disease.

Hypersensitivity reactions (eg, anaphylaxis, urticaria or generalized rash) have been reported. Patient should promptly seek medical advice about discontinuation of Myalept if a hypersensitivity reaction occurs.

Myalept contains benzyl alcohol when reconstituted with Bacteriostatic Water for Injection. The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients, particularly in neonates and premature infants. Preservative-free Water for Injection is recommended for use in neonates and infants.

ADVERSE REACTIONS: Most common adverse reactions (≥10%) in clinical trials were headache, hypoglycemia, decreased weight, and abdominal pain.

Please see Full Prescribing Information, including Boxed Warning.

Important Safety Information

WARNING: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA

ADVERSE REACTIONS: Most common adverse reactions (≥10%) in clinical trials were headache, hypoglycemia, decreased weight, and abdominal pain.

Please see Full Prescribing Information, including Boxed Warning.