Metreleptin, Injection

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KEY POINTS

• This medicine is given by injection to treat the problems caused by leptin deficiency in people with congenital or acquired generalized lipodystrophy. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: leptin analog

Generic and brand names: metreleptin, injection; Myalept

What is this medicine used for?

This medicine is given by injection to treat the problems caused by leptin deficiency in people with congenital or acquired generalized lipodystrophy.

This medicine is available only through a special program. Only a few pharmacies are allowed to provide it. Your healthcare provider will explain. For more information call 1-855-6MYALEPT.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to benzyl alcohol (a preservative)
• An autoimmune disease such as lupus, autoimmune hepatitis, or membranoproliferative glomerulonephritis
• Blood disorders or bone marrow problems
• Diabetes, and if you take any medicines to treat diabetes
• High triglycerides
• Kidney problems
• Lymphoma or swelling in your lymph nodes
• Obesity not caused by leptin deficiency
• Pancreatitis

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Talk with your healthcare provider about effective birth control. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Do not use more of it or use it longer than prescribed. Do not stop using this medicine without your healthcare provider’s approval. You may have to reduce your dosage gradually. If you stop using this medicine suddenly, it can cause very serious side effects.

You may be able to give yourself these shots or have someone at home give them to you. Be sure you know how and when to have them and how much medicine to use. Your healthcare provider will determine the exact dosage of the medicine. This medicine is usually given 1 time a day at the same time each day. Do not inject into the vein or muscle. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in infants. You need to follow special instructions for mixing the injections.

Do not shake the medicine after mixing. Do not use this medicine if it is colored or cloudy after you mix it, or has any lumps or particles in it. Throw the vial away and get a new one.

Do NOT mix this medicine and any other medicine, including insulin, in the same syringe or vial. Although this medicine and insulin doses may be given at the same time, do not inject this medicine and insulin in the same injection site.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Some people who use this medicine make antibodies in their blood that may reduce how well the leptin in your body works or how well this medicine works. This medicine may also increase your risk for lymphoma. Talk with your healthcare provider about this.

Follow the diet prescribed by your healthcare provider.

Low blood sugar (hypoglycemia) can happen if you are also taking another medicine that can cause low blood sugar. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Be sure to talk about this with your healthcare provider.

Rarely, this medicine may cause pancreatitis. If you have stomach pain that is severe and will not go away, with or without vomiting, or severe back pain, contact your healthcare provider right away.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe confusion; shaking; weakness; strong hunger; cold sweats; severe headache; vision problems; feeling faint; severe nausea or vomiting; loss of appetite; extreme thirst; fast, slow, or irregular heartbeat; severe dizziness; increasing drowsiness; unexplained tiredness or weakness; severe or sudden stomach or back pain; decreased or trouble urinating; unexplained fever, sore throat, or cough.

Other: Mild stomach pain, diarrhea, headache, weight loss, joint pain, stuffy or runny nose, dizziness.

What products might interact with this medicine?

When you take this medicine with other medicines; it can change the way this or any of the other medicines work. Nonprescription medicines; vitamins; natural remedies; and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, and tolbutamide
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), and norethindrone (Aygestin, Micronor) (Talk to your healthcare provider if you need birth control.)
• Theophylline
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator in the original carton. Do not let it freeze. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Do not shake the medicine after mixing.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.