Leuprolide is a prescription gonadotropin releasing hormone (GnRH) medicine.

Leuprolide overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer (but does not treat the cancer itself). Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children at least 2 years old.

Your symptoms may become temporarily worse when you first start using leuprolide. Tell your doctor if this continues for longer than 2 months.

Call your doctor at once if you have a seizure, or unusual changes in mood or behavior.

Do not use if you are pregnant.

Before taking this medicine

You should not use leuprolide if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Leuprolide can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength.

To make sure leuprolide is safe for you, tell your doctor if you have ever had:

• depression, mental illness or psychosis;

• seizures or epilepsy;

• a blood vessel disorder;

• a brain tumor or spinal cord injury;

• heart disease, congestive heart failure, long QT syndrome;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Do not give this medicine to any child without medical advice.

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy. Leuprolide can make hormonal birth control less effective (birth control pills, injections, implants, skin patches, vaginal rings).

Call your doctor if your periods continue while you are being treated with this medicine.

You should not breast-feed while using this medicine.

Take leuprolide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Different brands or strengths of leuprolide are used to treat different conditions. It is very important that you receive exactly the brand and strength your doctor has prescribed. Always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

Leuprolide is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider can teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use leuprolide if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Your symptoms may become temporarily worse as your hormones adjust to leuprolide. A child using this medicine may have increased signs of puberty (such as vaginal bleeding) during the first weeks of treatment.

Keep using the medicine as directed, and tell your doctor if your condition is still worse after 2 months of using this medicine.

You may need frequent medical tests while using leuprolide. Bone growth may need to be checked in a child treated with Fensolvi.

Store Lupron in the original carton at room temperature, away from moisture and heat. Protect from light.

Store Eligard or Fensolvi in the refrigerator. Do not freeze. You may take the medicine out and allow it to reach room temperature before mixing and injecting your dose. Mixed medicine must be used within 30 minutes.

You may also store Eligard or Fensolvi in its original packaging at room temperature for up to 8 weeks.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Endometriosis:

3.75 mg IM once a month for up to 6 months
OR
11.25 mg depot every 3 months

Comments:
-In women receiving this drug for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms.

Uses: Management of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata

Usual Adult Dose for Prostate Cancer:

Eligard: administered by subcutaneous injection and provides continuous release of leuprolide acetate over a one, three, four, or six-month period:

• One 7.5 mg injection every month; or

• One 22.5 mg injection every 3 months; or

• One 30 mg injection every 4 months; or

• One 45 mg injection every 6 months,

Viadur: one implant inserted for 12 months. Each implant contains 65 mg leuprolide. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of leuprolide for 12 months of hormonal therapy.

Usual Pediatric Dose for Precocious Puberty:

IM Injection:
2 years and older:
One month depot injection: 25 kg or less: 7.5 mg IM once a month. Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month. Greater than 37.5 kg: 15 mg IM once a month
Three month depot injection: 11.25 mg or 30 mg IM every 3 months

Comments:
-Doses should be titrated to the individual.
-Hormone levels should be tested after 1 to 2 months of therapy and with each dose change to ensure adequate pituitary gonadotropin suppression.
-Once a dose that results in adequate hormonal suppression has been determined, it can often be maintained for the duration of therapy in most children; however, hormonal suppression should be verified as weight can increase significantly while on therapy.
-Therapy should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.

Subcutaneous injection:
2 years and older:
Fensolvi (long acting formulation): 45 mg subcutaneously every 6 months
NOTE: The short-acting formulation has been replaced with long-acting formulations.

Comments:
-The dosage should be adjusted for weight changes.
-Discontinuation of therapy be considered before age 11 for females and before age 12 for males.

Use: Treatment of children with central precocious puberty (CPP); CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years in girls and 9 years in boys) associated with pubertal pituitary gonadotropin activation; it may show a significantly advanced bone age that can result in diminished adult height

You should not use leuprolide if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Leuprolide can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength.

To make sure leuprolide is safe for you, tell your doctor if you have ever had:

• depression, mental illness or psychosis;

• seizures or epilepsy;

• a blood vessel disorder;

• a brain tumor or spinal cord injury;

• heart disease, congestive heart failure, long QT syndrome;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Do not give this medicine to any child without medical advice.

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy. Leuprolide can make hormonal birth control less effective (birth control pills, injections, implants, skin patches, vaginal rings).

Call your doctor if your periods continue while you are being treated with this medicine.

You should not breast-feed while using this medicine.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to leuprolide (hives, sweating, fast heartbeats, dizziness, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• problems with your pituitary gland - sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;

• bone pain, loss of movement in any part of your body;

• swelling, rapid weight gain;

• a seizure;

• unusual changes in mood or behavior (crying spells, anger, feeling irritable);

• sudden chest pain or discomfort, wheezing, dry cough or hack;

• painful or difficult urination; or

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

Rare but serious side effects may occur. Call your doctor if you have:

• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;

• muscle weakness or loss of use, loss of bowel or bladder control;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech.

Common leuprolide side effects may include:

• pituitary gland problems;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;

• fever, tiredness, not feeling well;

• stomach pain, nausea, vomiting, constipation;

• wheezing, chest tightness, trouble breathing;

• hot flashes, sweating;

• dizziness, mood changes;

• headache, general pain;

• vaginal swelling, itching, or discharge;

• weight changes;

• decreased testicle size;

• decreased interest in sex; or

• redness, pain, swelling, or oozing where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Leuprolide can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.