Myalept

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

Myalept 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 Myalept include headache, low blood sugar, weight loss, and abdominal pain.

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

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Amylin Pharmaceuticals, LLC

Serious side effects have been reported with Myalept. See the “Myalept Precautions” section.

Common side effects of Myalept include the following:

• Headache
• Low blood sugar
• Weight loss
• Abdominal pain

This is not a complete list of Myalept side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Myalept including the following:

• Headache
• Weight loss
• Abdominal pain

Meterleptin can also cause hypoglycemia. Symptoms of hypoglycemia include dizziness or lightheadedness, drowsiness or confusion, and blurred vision.

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

Myalept has been associated with the production of anti-Myalept antibodies, which can lead to severe infection or worsening metabolic control. It is also associated with a risk of T-cell lymphoma. Meterleptin is available only through a restricted program.

Do not take Myalept if you:

• are allergic to Myalept or to any of its ingredients
• have obesity not related to lipodystrophy

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Myalept, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Myalept, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Myalept or to any of its ingredients
• have liver problems
• have HIV-related lipodystrophy
• have metabolic disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Myalept falls into category C. In animal studies, pregnant animals were given this medication and the mothers and babies had increased problems and complications before, during, and after birth. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Myalept crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Myalept.

Take Myalept 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 Myalept at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your weight
• your gender

The recommended dose range of Myalept for the treatment complications related to leptin deficiency in patients with generalized lipodystrophy is 0.06 to 0.13 mg/kg/day for patients who weigh less than 40 kg. For males who weigh greater than 40 kg, the recommended dose range is 2.5 to 10 mg/day, and for females who weigh greater than 40 kg, the recommended dose range is 5 to 10 mg/day.

If you take too much Myalept, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Myalept is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store Myalept in the refrigerator (between 36°F and 46°F).

Protect from light until ready to use.

Keep this and all medicines out of the reach of children.

After reconstitution, the solution should be clear and colorless. Do not use if particles are visible in the solution.

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

Anti-Myalept 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-Myalept antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of MYALEPT efficacy during treatment. Contact AstraZeneca 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-Myalept 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.