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Metreleptin

Generic Name: Metreleptin (met re LEP tin)
Brand Name: Myalept

Warning

  • Some people who use metreleptin make antibodies in their blood. These may lower how well a hormone (leptin) in the body works. They may also lower how well this medicine works. Side effects may also happen. These could be infection, problems with blood sugar like diabetes, and raised fats in the blood. Talk with the doctor.
  • A certain type of lymphoma has happened in people with this health problem. This has happened in people both treated and not treated with metreleptin. Tell your doctor if you have ever had any immune system or bone marrow problems. Talk with your doctor.
  • You may only get this medicine through a special program. Talk with your doctor.

Uses of Metreleptin:

  • It is used to treat problems caused by not having enough of a certain hormone (leptin) in the body. It is only for use in people with congenital or acquired generalized lipodystrophy.

What do I need to tell my doctor BEFORE I take Metreleptin?

  • If you have an allergy to metreleptin or any other part of metreleptin.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your health problem is not caused by not having enough leptin in your body.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take metreleptin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Metreleptin?

  • 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.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking metreleptin with your other drugs.
  • Some fluids used to mix this medicine 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 metreleptin while you are pregnant.

How is this medicine (Metreleptin) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Wash your hands before and after use.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • A few fluids can be used to mix metreleptin. Be sure you know which fluid to use. Talk with your doctor or pharmacist if you are not sure.
  • Let this medicine come to room temperature before mixing. Do not heat metreleptin.
  • Do not shake.
  • Move site where you give the shot each time.
  • Take with or without food.
  • Take this medicine at the same time of day.
  • Do not mix with any other liquid drugs.
  • Do not mix metreleptin in the same syringe with insulin.
  • Give this medicine at some other site from where you gave your insulin if you are also getting insulin.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Dizziness or passing out.
  • A fast heartbeat.
  • Trouble swallowing.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very bad belly pain.
  • Pelvic pain or pressure.
  • Vaginal bleeding that is not normal.
  • Feeling very tired or weak.
  • Low blood sugar can happen. The chance of low blood sugar may be raised when metreleptin is used with other drugs for high blood sugar (diabetes). Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call your doctor right away if you have any of these signs. Follow what you have been told to do if you get low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.

What are some other side effects of Metreleptin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Belly pain.
  • Weight loss.
  • Joint pain.
  • Ear pain.
  • Feeling tired or weak.
  • Upset stomach.
  • Signs of a common cold.
  • Back pain.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Metreleptin?

  • Before mixing, store in the refrigerator.
  • Do not freeze.
  • Protect from light.
  • Store vials in carton.
  • After mixing, be sure you know how long the product is good for and how to store it. Ask your doctor or pharmacist if you are not sure.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about metreleptin, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about metreleptin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using metreleptin.

Review Date: December 6, 2017

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