Metreleptin solution for injection

What is this medication?

Metreleptin (met re LEP tin) is a human leptin analog. It is used to treat the symptoms of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. This medicine is not a cure.

This medicine may be used for other purposes; ask your healthcare provider or pharmacist if you have questions.

COMMON BRAND NAME(S): MYALEPT

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone marrow problems.
• Cancer.
• Diabetes.
• History of pancreatitis.
• High triglyceride levels.
• Immune system problems.
• Liver disease.
• Low blood counts, like low white cell counts.
• Obesity not caused by a congenital leptin deficiency.
• Pancreatic disease.
• Signs of infection.
• Swollen lymph nodes.
• An unusual or allergic reaction to metreleptin, other medications, foods, dyes, or preservatives.
• Pregnant or trying to get pregnant.
• Breast-feeding.

How should I use this medication?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• Certain medicines for diabetes, like insulin, glipizide, or glyburide.
• Certain medicines that treat or prevent blood clots like warfarin.
• Cyclosporine.
• Female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections.
• Theophylline.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take the medicine.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine. Learn the symptoms of low and high blood sugar and how to manage them.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Do not stop taking except on your doctor's advice.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue.
• Breathing problems.
• Signs and symptoms of low blood sugar such as feeling anxious; confusion; dizziness; increased hunger; unusually weak or tired; sweating; shakiness; cold; irritable; headache; blurred vision; fast heartbeat; loss of consciousness.

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Decreased weight.
• Diarrhea.
• Fever.
• Joint pain.
• Nausea.
• Pain, redness, or irritation at site where injected.
• Stomach pain.
• Tiredness.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

You will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.