When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to leuprolide or similar medicines, or if you are pregnant or breastfeeding.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and schedule. This medicine is given as a shot into a muscle or under the skin. Leuprolide injection is given on different schedules for different conditions. It might be given every day, once a month, or every few months.
• 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.
• 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
• If you store this medicine at home, keep it at room temperature, away from heat, moisture, and direct light.

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 foods and medicines can affect how leuprolide works. Tell your doctor if you are using the following:
  
  • Medicine to treat heart rhythm problems
  • Medicine to treat depression (such as bupropion)
  • Medicine to treat seizures
  • Steroid medicine (such as hydrocortisone, methylprednisolone, prednisone, prednisolone, or dexamethasone)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Women who are using this medicine should use birth control that does not contain hormones.
• Tell your doctor if you have kidney disease, heart failure, diabetes, heart or blood vessel disease, heart rhythm problems (such as long QT syndrome), problems with your nervous system, or a history of depression, seizures, or stroke.
• Women: Your menstrual periods should stop, but you might have light bleeding or spotting. If you continue to have heavy bleeding or regular periods, call your doctor.
• This medicine may cause the following problems:
  
  • Heart rhythm changes
  • Weaker bones, which may lead to osteoporosis
  • Problems with the urinary tract or spinal cord (in men)
  • Changes in blood sugar levels (in men)
  • Higher risk of heart attack or stroke (in men)
• Your symptoms might get worse when you first start using this medicine, but then they should get better as the medicine starts to work. If your condition does not begin to improve after 2 weeks, call your doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. 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
• Change in how much or how often you urinate
• Depression or severe moodiness or emotional problems
• Fast, pounding, or uneven heart beat
• Heavy vaginal bleeding
• Seizures
• Unusual or severe bone or back pain

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

• Headache
• Hot flashes and sweating, warmth or redness in your face, neck, arms, or upper chest
• Loss of interest in sex, sexual problems
• Moodiness
• Pain, itching, burning, bruises, or swelling where the shot was given

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