What is Myalept? | Myalept cost | Myalept price 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.
Warnings 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. Myalept cost| Myalept price
Before taking this medicine You should not use Myalept if you are allergic to metreleptin.
This medicine is not for use in treating obesity that is unrelated to leptin deficiency.
Myalept is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks of taking this medication.
To make sure Myalept is safe for you, tell your doctor if you have:
a blood cell disorder, or history of low white blood cell (WBC) counts;
liver disease (including “fatty liver”);
diabetes (especially if you use insulin or oral diabetes medicine);
high triglycerides (a type of fat in the blood);
any other metabolic disorder;
an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
a history of pancreatitis;
bone marrow suppression; or
a history of lymphoma (cancer of the lymph nodes).
It is not known whether Myalept will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether metreleptin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
INDICATIONS Patients With Generalized Lipodystrophy MYALEPT (metreleptin) for injection is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Myalept cost| Myalept price
Limitations Of Use
The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established.
The safety and effectiveness of MYALEPT 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 cost| Myalept price
MYALEPT is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy. Myalept cost| Myalept price
DOSAGE AND ADMINISTRATION Recommended Dosing See Table 1 for the recommended daily dose and maximum recommended daily dose in adults and pediatric patients.
Based on clinical response (e.g., inadequate metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss [especially in pediatric patients]), MYALEPT dosage may be decreased or increased to the maximum dosage listed in Table 1. Myalept cost| Myalept price
Table 1: MYALEPT Recommended Dosage
Baseline weight
Starting daily dose (injection volume)
Dose adjustments (injection volume)
Maximum daily dose (injection volume)
Less than or equal to 40 kg (males and females)
0.06 mg/kg (0.012 mL/kg)
0.02 mg/kg (0.004 mL/kg)
0.13 mg/kg (0.026 mL/kg)
Males greater than 40 kg
2.5 mg (0.5 mL)
1.25 mg (0.25 mL) to 2.5 mg (0.5 mL)
10 mg (2 mL)
Females greater than 40 kg
5 mg (1 mL)
1.25 mg (0.25 mL) to 2.5 mg (0.5 mL)
10 mg (2 mL)
In pediatric patients, small volumes for administration can result in medication errors when measured incorrectly [see DOSAGE AND ADMINISTRATION , ADVERSE REACTIONS ]. Table 2 provides example doses and volumes by weight. For patients using insulin syringes, the volume conversion is 100 Units/mL. Myalept cost| Myalept price
Table 2: Example Dosing Chart for Patients Less than or Equal to 40 kg
Weight
Starting Dose
Dose Adjustment
Maximum Dose
5 kg
0.30 mg (0.06 mL or 6 Units)
0.10 mg (0.02 mL or 2 Units)
0.65 mg (0.13 mL or 13 Units)
10 kg
0.60 mg (0.12 mL or 12 Units)
0.20 mg (0.04 mL or 4 Units)
1.3 mg (0.26 mL or 26 Units)
15 kg
0.90 mg (0.18 mL or 18 Units)
0.30 mg (0.06 mL or 6 Units)
1.95 mg (0.39 mL or 39 Units)
20 kg
1.2 mg (0.24 mL or 24 Units)
0.40 mg (0.08 mL or 8 Units)
2.6 mg (0.52 mL or 52 Units)
25 kg
1.5 mg (0.3 mL or 30 Units)
0.50 mg (0.1 mL or 10 Units)
3.25 mg (0.65 mL or 65 Units)
30 kg
1.8 mg (0.36 mL or 36 Units)
0.60 mg (0.12 mL or 12 Units)
3.9 mg (0.78 mL or 78 Units)
35 kg
2.1 mg (0.42 mL or 42 Units)
0.70 mg (0.14 mL or 14 Units)
4.55 mg (0.91 mL or 91 Units)
40 kg
2.4 mg (0.48 mL or 48 Units)
0.80 mg (0.16 mL or 16 Units)
5.2 mg (1.03 mL or 103 Units)
MYALEPT should be administered once daily at the same time every day. MYALEPT can be administered any time of day without regard to the timing of meals. Myalept cost| Myalept price
Instruct patients that if a dose is missed, administer the dose as soon as noticed, and resume the normal dosing schedule the next day. Myalept cost| Myalept price
MYALEPT Preparation And Storage Healthcare practitioners should provide proper training to patients and caregivers regarding how to prepare and administer the correct dose of MYALEPT prior to self-use. The patients and caregivers should prepare and administer the first dose of MYALEPT under the supervision of a qualified healthcare professional. Myalept cost| Myalept price
Instruct patients to store the vials of lyophilized powder in their carton in the refrigerator as soon as received [see HOW SUPPLIED /Storage And Handling ]. Myalept cost| Myalept price
MYALEPT can be reconstituted aseptically with 2.2 mL of sterile Bacteriostatic Water for Injection (BWFI), USP (0.9% benzyl alcohol), or with 2.2 mL of sterile Water for Injection (WFI). Myalept cost| Myalept price
When reconstituted in 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 [see HOW SUPPLIED /Storage And Handling ]. Discard unused reconstituted solution after 3 days. Attach the supplied sticker to the vial and enter the discard date. Myalept cost| Myalept price
For use in neonates and infants, reconstitute with preservative-free sterile WFI [see WARNINGS AND PRECAUTIONS and Use In Specific Populations ]. When reconstituted in sterile WFI, MYALEPT should be administered immediately. Unused reconstituted solution cannot be saved for later use and should be discarded . Myalept cost| Myalept price
$140,585.00
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