When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to metreleptin, or if you have obesity not caused by congenital leptin deficiency.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in your stomach, thighs, or upper arms.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to. A home health caregiver may also give you this medicine.
• This medicine should be given at the same time each day.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Use a new needle and syringe each time you inject your medicine.
• The powder medicine in the vial should be white and not discolored. Do not use the mixed medicine if it is cloudy, discolored, or has large particles in it.
• Do not shake the mixed medicine.
• Do not mix this medicine and insulin in the same syringe or vial. Also, do not inject this medicine and insulin at the same injection site.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the unused vials in the refrigerator. Protect from direct light. Do not freeze.
• Store the medicine mixed with bacteriostatic water for injection (BWFI) in the refrigerator. This mixture can be used for up to 3 days when stored in the refrigerator and away from direct light. Throw away any unused medicine after 3 days.
• Do not store the medicine mixed with sterile water for injection (WFI). This mixture should be used right away. Do not save it for later use.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how metreleptin works. Tell your doctor if you are using cyclosporine, theophylline, insulin or diabetes medicine that you take by mouth, or a blood thinner (such as warfarin).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have blood or bone marrow problems, an autoimmune disease, high triglyceride levels, swollen lymph nodes, or a history of pancreas problems.
• This medicine may cause the following problems:
  
  • Antibodies made by your blood that reduce how well leptin works
  • An increased risk for lymphoma (a blood cancer)
  • Low blood sugar (when used with insulin or a diabetes medicine)
• This medicine can be mixed with bacteriostatic water for injection (BWFI) or sterile water for injection (WFI). This medicine mixed with BWFI contains benzyl alcohol, which may cause serious reactions in premature or newborn infants. WFI is recommended for use in infants. Ask your doctor which liquid should be mixed with your medicine.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Headache or dizziness
• Weight loss, nausea, or stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088