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Leuprolide is a prescription hormone medication used for several conditions, including the treatment of the symptoms of advanced prostate cancer, endometriosis, anemia caused by uterine fibroids, and early puberty.

Leuprolide belongs to a group of drugs called GnRH agonists, which work by decreasing the amount of certain hormones in the body.

Leuprolide injection comes as a long-acting suspension that is injected into a muscle (IM) by a healthcare provider in a medical office or clinic and is usually given once a month or every 3, 4, or 6 months. Leuprolide injection also comes as a long-acting suspension that is injected just under the skin by a healthcare provider in a medical office or clinic and is usually given every 1, 3, 4, or 6 months.

Common side effects include hot flashes, generalized pain, and irritation or pain at the site of injection.

Leuprolide is a prescription hormone medication used for several conditions, including prostate cancer, endometriosis, and central precocious puberty (CPP). CPP is early puberty that occurs generally in girls 8 years of age or younger and in boys 9 years of age or younger.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bayer Corp., Pharmaceutical/Biological Division

• Bayer Pharmaceuticals Corporation

Serious side effects have been reported. See the “Drug Precautions” section.

Common side effects include:

• hot flashes
• headache
• generalized pain
• irritation or pain at the site of injection
• mood changes
• fatigue
• acne
• rash
• swelling
• vaginal bleeding or discharge, dryness, and itching
• weight gain

This is not a complete list of leuprolide side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amiodarone (Cordarone, Pacerone)
• bupropion (Zyban, Wellbutrin)
• dexamethasone (Decadron)
• disopyramide (Norpace)
• methylprednisolone (Medrol)
• prednisone (Deltasone)
• procainamide (Procanbid)
• quinidine
• sotalol (Betapace)
• seizure medications
• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem, Symbyax), and fluvoxamine (Luvox)

This is not a complete list of leuprolide drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with leuprolide including:

• signs of puberty
• seizures
• urinary blockage
• increased risk for heart attack or stroke
• increased risk for osteoporosis or fractures
• increased risk for diabetes or raised blood glucose (sugar) levels
• impotence
• worsening of depression

Do not take leuprolide if you:

• are allergic to any of its ingredients
• have vaginal bleeding
• are pregnant or planning to become pregnant
• are breastfeeding

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of leuprolide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking leuprolide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic leuprolide
• have a history of seizures
• have a history of brain trauma or injury
• have a history of heart attack
• have osteoporosis
• are unable to urinate
• have anemia
• have epilepsy
• are pregnant or planning to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Leuprolide falls into category X. This medication is not to be used in women who are or may become pregnant. If this drug is used during pregnancy, or if you become pregnant while taking the drug, be aware of the potential risk to the unborn child. The possibility exists that spontaneous abortion may occur if the drug is taken during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether this medication is excreted in human milk. Nursing mothers should not use leuprolide.

Take leuprolide exactly as prescribed.

Leuprolide injection comes as a long-acting suspension that is injected into a muscle (IM) by a healthcare provider in a medical office or clinic and is usually given once a month or every 3, 4, or 6 months, depending on the form prescribed. Leuprolide injection also comes as a long-acting suspension that is injected just under the skin by a healthcare provider in a medical office or clinic and is usually given every 1, 3, 4, or 6 months.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of leuprolide at the same time.

If you take too much leuprolide, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

• Do not store near a radiator or other very warm place.
• Do not freeze.
• Protect from light
• Store vial in carton until use.
• Keep this and all medicines out of the reach of children.