Metreleptin

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.

Metreleptin is not for use in people who have lipodystrophy caused by taking medicine to treat HIV or AIDS.

Metreleptin may also be used for purposes not listed in this medication guide.

In some people, metreleptin 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.

You should not use metreleptin if you are allergic to it. Metreleptin is not for use in treating obesity that is unrelated to leptin deficiency.

Metreleptin 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 metreleptin 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 metreleptin 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.

Metreleptin is a prescription medication used to treat complications related to leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Metreleptin is an analog of the hormone leptin. It works by replacing leptin that cannot be produced by the body.

This medication is available as a solid, dry cake that must be reconstituted with bacteriostatic water for injection or preservative-free sterile water for injection. The reconstituted solution is injected subcutaneously once daily.

Common side effects of metreleptin include headache, low blood sugar, weight loss, and abdominal pain.

Meterleptin can also cause drowsiness. Do not drive or operate heavy machinery until you know how metreleptin affects you.

Metreleptin may be found in some form under the following brand names:

• Myalept

Take metreleptin exactly as prescribed.

This medication is available as a solid, dry cake that must be reconstituted with bacteriostatic water for injection or preservative-free sterile water for injection. The reconstituted solution is injected subcutaneously once daily.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of metreleptin at the same time.

You should not use metreleptin if you are allergic to it.

Metreleptin is not for use in treating obesity that is unrelated to leptin deficiency.

Metreleptin 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 metreleptin 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 metreleptin 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.

Usual Adult Dose for Lipodystrophy:

Weight 40 kg or less (males and females):
-Initial dose: 0.06 mg/kg subcutaneously once a day
-Adjust dose in 0.02 mg/kg increments based on clinical response
-Maximum dose: 0.13 mg/kg/day

Weight greater than 40 kg:
-Initial dose: Males: 2.5 mg subcutaneously once a day
-Initial dose: Females: 5 mg subcutaneously once a day
-Adjust dose in 1.25 to 2.5 mg increments based on clinical response
-Maximum dose: 10 mg/day

Comments: Dose adjustments should be made based on clinical response (e.g., metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss).

Use: As an adjunct to diet, used as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

Usual Pediatric Dose for Lipodystrophy:

Weight 40 kg or less (males and females):
-Initial dose: 0.06 mg/kg subcutaneously once a day
-Adjust dose in 0.02 mg/kg increments based on clinical response
-Maximum dose: 0.13 mg/kg/day

Weight greater than 40 kg:
-Initial dose: Males: 2.5 mg subcutaneously once a day
-Initial dose: Females: 5 mg subcutaneously once a day
-Adjust dose in 1.25 to 2.5 mg increments based on clinical response
-Maximum dose: 10 mg/day

Comments: Dose adjustments should be made based on clinical response (e.g., metabolic control) or other considerations (e.g., tolerability issues, excessive weight loss).

Use: As an adjunct to diet, used as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

No formal drug interaction studies to date.1

Storage

Parenteral

2–8°C; do not freeze.1 5 Store in original carton, protect from light before use.1 5 Do not leave at room temperature for more than 4 hours.7

Reconstitution with bacteriostatic water for injection: 2–8°C for up to 3 days;1 5 7 room temperature for up to 4 hours.7 Protect from light; do not freeze.1 5

Reconstitution with preservative-free water for injection: Use immediately; discard any unused solution.1 5

• Recombinant analog of human leptin; replaces deficient leptin in patients with generalized lipodystrophy.1 4

• Binds to and activates leptin receptors; increases insulin sensitivity, improves lipid metabolism, and reduces caloric intake in patients with leptin deficiency.1 12

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Follow the diet plan that your doctor told you about.
• Do not stop taking metreleptin all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• If you have had an autoimmune disease your sign may get worse. Talk with your doctor.
• This medicine may lower your blood sugar levels. The chance may be raised if you also take insulin or other drugs that lower blood sugar. Talk with your doctor.
• Check your blood sugar as you have been told by your doctor.
• Some fluids used to mix metreleptin have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. It may cause very bad and sometimes deadly side effects. Talk with the doctor to see which fluids have benzyl alcohol.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.