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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

Get Support Information

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

Important Safety Information

What is Myalept?

Myalept^® (metreleptin) is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin (leptin deficiency) in people with generalized lipodystrophy.

It is not known if Myalept is safe and effective when used to treat problems (complications) caused by partial lipodystrophy or to treat liver disease, including non-alcoholic steatohepatitis (NASH)
Myalept should not be used to treat people with HIV-related lipodystrophy or people with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without signs or symptoms of congenital or acquired generalized lipodystrophy.

Important Safety Information

Myalept is only available through a restricted program called the Myalept Risk Evaluation and Mitigation Strategy (REMS) Program. Your doctor must be enrolled and certified in the program in order to prescribe Myalept.

Myalept may cause serious side effects, including:

risk for developing certain proteins called neutralizing antibodies that may reduce how well your own leptin or Myalept works. Side effects of these antibodies may include infection, problems with blood sugar (including diabetes), or an increase in triglycerides.
increased risk of a type of blood cancer called lymphoma.

You should not take Myalept if you:

have general obesity not caused by a congenital leptin deficiency.
are allergic to metreleptin or any of the ingredients in Myalept. Symptoms of an allergic reaction include rash, itching (hives), swelling of face, lips, tongue, or throat, problems breathing or swallowing, fainting or dizziness, rapid heartbeat.

Before using Myalept, tell your doctor if you have any medical conditions including if you:

have or have had problems with your blood cells, including low blood cell counts (especially your white blood cells), bone marrow, immune system, pancreas, swollen lymph nodes, lymphoma, high blood triglyceride levels, or use insulin or a sulfonylurea.
are pregnant or plan to become pregnant as it is unknown if Myalept will harm your unborn baby. If you become pregnant while using Myalept, talk to your healthcare provider about registering with a program to collect information about the outcomes of moms and babies exposed to Myalept during pregnancy. You can enroll in the Myalept program by calling 1-855-669-2537.
are nursing or plan to nurse. You should not nurse while you take Myalept.

Other possible side effects

The most common side effects of Myalept include headache, low blood sugar, decreased weight, and/or abdominal pain.

You may get low blood sugar (hypoglycemia) if you take Myalept with other medicines used to lower blood sugar, such as insulin or sulfonylurea. Your doses of these medications may need to be lowered while you use Myalept. Tell your doctor right away if you experience shakiness, sweating, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, or a jittery feeling because these may be signs of low blood sugar (hypoglycemia).

For newborns and infants, mix Myalept with sterile water for injection (preservative-free) (WFI). Serious side effects including death have happened in newborns or infants who have received the preservative benzyl alcohol. Bacteriostatic water for injection contains benzyl alcohol and it should not be used to mix Myalept for newborns and infants.

Myalept may worsen symptoms caused by certain problems in your immune system (autoimmune disorder). Ask your doctor about what symptoms you should watch for that may require further testing.

Talk to your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of Myalept. For more information, speak to your doctor or pharmacist. Tell your doctor about all the medications you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Take Myalept exactly as your doctor instructs you.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This is the most important information about Myalept. For more detailed information, please see the patient Medication Guide and Full Prescribing Information including Boxed Warning.

Important Safety Information

What is Myalept?

It is not known if Myalept is safe and effective when used to treat problems (complications) caused by partial lipodystrophy or to treat liver disease, including non-alcoholic steatohepatitis (NASH)
Myalept should not be used to treat people with HIV-related lipodystrophy or people with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without signs or symptoms of congenital or acquired generalized lipodystrophy.

Important Safety Information

Myalept may cause serious side effects, including:

risk for developing certain proteins called neutralizing antibodies that may reduce how well your own leptin or Myalept works. Side effects of these antibodies may include infection, problems with blood sugar (including diabetes), or an increase in triglycerides.
increased risk of a type of blood cancer called lymphoma.

You should not take Myalept if you:

have general obesity not caused by a congenital leptin deficiency.
are allergic to metreleptin or any of the ingredients in Myalept. Symptoms of an allergic reaction include rash, itching (hives), swelling of face, lips, tongue, or throat, problems breathing or swallowing, fainting or dizziness, rapid heartbeat.

Before using Myalept, tell your doctor if you have any medical conditions including if you:

have or have had problems with your blood cells, including low blood cell counts (especially your white blood cells), bone marrow, immune system, pancreas, swollen lymph nodes, lymphoma, high blood triglyceride levels, or use insulin or a sulfonylurea.
are pregnant or plan to become pregnant as it is unknown if Myalept will harm your unborn baby. If you become pregnant while using Myalept, talk to your healthcare provider about registering with a program to collect information about the outcomes of moms and babies exposed to Myalept during pregnancy. You can enroll in the Myalept program by calling 1-855-669-2537.
are nursing or plan to nurse. You should not nurse while you take Myalept.

Other possible side effects

The most common side effects of Myalept include headache, low blood sugar, decreased weight, and/or abdominal pain.

Myalept may worsen symptoms caused by certain problems in your immune system (autoimmune disorder). Ask your doctor about what symptoms you should watch for that may require further testing.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This is the most important information about Myalept. For more detailed information, please see the patient Medication Guide and Full Prescribing Information including Boxed Warning.