Uses^1,2

LUPRON DEPOT^® (leuprolide acetate for depot suspension) 3.75 mg and 3-month 11.25 mg with iron therapy are used before fibroid surgery to improve anemia due to vaginal bleeding from fibroids. Your doctor may consider a one-month trial of iron alone as some patients’ anemia will improve with iron alone. It is recommended that LUPRON DEPOT not be used for more than 3 months in patients with fibroids. Experience with LUPRON DEPOT in females has been limited to women 18 years of age and older.

LUPRON DEPOT^® (leuprolide acetate for depot suspension) 3.75 mg and 3-month 11.25 mg are used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT with daily norethindrone acetate 5 mg as add-back therapy is also used for initial management of endometriosis and for management of recurrence of symptoms. The recommended initial treatment is no more than 6 months. Repeat treatment for endometriosis should be limited to 6 months.

LUPRON DEPOT^® (leuprolide acetate for depot suspension) 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month administration are prescribed for the palliative treatment of advanced prostate cancer.

LUPRON DEPOT-PED^® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg, and 15 mg are used for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Doctors will also perform tests to rule out possible causes of CPP that would require different treatment (i.e., tumors).

Important Safety Information You Should Know About LUPRON DEPOT^® (leuprolide acetate for depot suspension)¹ and LUPRON DEPOT-PED^®2

People who have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs should not take LUPRON DEPOT or LUPRON DEPOT-PED.

LUPRON DEPOT 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month administration should not be used in women.

Females who are or may be pregnant, are breastfeeding, or have undiagnosed vaginal bleeding should not receive LUPRON DEPOT-PED or LUPRON DEPOT.

LUPRON DEPOT must be administered in your doctor’s office.

Endometriosis

Thinning of the bones may occur during therapy with LUPRON DEPOT (leuprolide acetate for depot suspension), which may not be completely reversible in some patients. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones.

After beginning LUPRON DEPOT, your estrogen levels will increase for 1 or 2 weeks. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.

LUPRON DEPOT is not a method of birth control. Even though you may not have periods, unprotected intercourse could result in pregnancy. You should use non-hormonal birth control such as condoms, a diaphragm with contraceptive jelly, or an IUD to prevent pregnancy. If you think you have become pregnant while on LUPRON DEPOT, talk to your doctor immediately.

LUPRON DEPOT given with norethindrone acetate as add-back therapy may lower your HDL-cholesterol level (the “good” cholesterol). You should not take norethindrone acetate as add-back therapy with LUPRON DEPOT if you currently have or have previously had any clotting disorder, heart disease, stroke, liver disease, or breast cancer.

Tell your health care provider before beginning treatment with norethindrone acetate as add-back therapy if you currently have or have previously had high cholesterol, migraines, epilepsy, or depression, or if you smoke.

During treatment with LUPRON DEPOT and norethindrone acetate as add-back therapy, immediately tell your doctor if you have a sudden loss of vision, double vision, or if migraine headaches occur. You should notify your doctor if you experience fluid retention, epilepsy, asthma or worsening of asthmatic symptoms, or heart or kidney problems.

There is a possibility of the development or worsening of depression and/or the occurrence of forgetfulness. Patients who have a history of depression should be carefully observed during treatment.

The most common side effects of LUPRON DEPOT include hot flashes, vaginal dryness, headaches, changes in mood, decreased interest in sex, depression, and the occurrence of forgetfulness.

Fibroid

Thinning of the bones may occur during therapy with LUPRON DEPOT (leuprolide acetate for depot suspension), which may not be completely reversible in some patients. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones.

After beginning LUPRON DEPOT, your estrogen levels will increase for 1 or 2 weeks. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.

LUPRON DEPOT is not a method of birth control. Even though you may not have periods, unprotected intercourse could result in pregnancy. You should use non-hormonal birth control such as condoms, a diaphragm with contraceptive jelly, or an IUD to prevent pregnancy. If you think you have become pregnant while on LUPRON DEPOT, talk to your doctor immediately.

There is a possibility of the development or worsening of depression and/or the occurrence of forgetfulness. Patients who have a history of depression should be carefully observed during treatment.

The most common side effects of LUPRON DEPOT include hot flashes, vaginal dryness, headaches, changes in mood, decreased interest in sex, depression, and the occurrence of forgetfulness.

Prostate

LUPRON DEPOT (leuprolide acetate for depot suspension) causes an increase in testosterone during the first few weeks of therapy. Some men may experience temporary new or worsening symptoms of prostate cancer, including urinary symptoms and/or bone pain. If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be life threatening. You may require close medical attention during the first few weeks of therapy.

Notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment. Regular blood tests are needed to check your testosterone and PSA levels.

High blood sugar and increased risk of diabetes can occur in men using LUPRON DEPOT. Your doctor will monitor your blood sugar during treatment.

Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. Discuss this increased risk with your doctor before starting treatment and report any new symptoms during treatment.

Long-term use of LUPRON DEPOT can affect the electrical activity of your heart. Your doctor must determine if the benefits of using LUPRON DEPOT outweigh the risks, especially if you have congenital long QT syndrome, abnormal blood tests for electrolytes, congestive heart failure, or if you take medications to regulate your heartbeat.

LUPRON DEPOT may cause impotence.

The most common side effects of LUPRON DEPOT include hot flashes/sweats, injection site reaction/pain, general pain, swelling, testicular shrinkage, difficulty urinating, fatigue/weakness, headache, and joint, GI, and respiratory problems.

Central Precocious Puberty (CPP)

After starting LUPRON DEPOT-PED (leuprolide acetate for depot suspension) therapy, your child may experience increased signs and symptoms of CPP during the first few weeks of treatment.

You should notify the doctor if your child has menstrual bleeding that continues beyond the second month of treatment, has irritation at the injection site, develops mood swings or behavioral changes, or has any other unusual signs or symptoms.

It is important that you keep your child’s doctor appointments. If your child misses a shot or is a week late, your child’s pubertal development could begin again.

Response to LUPRON DEPOT-PED should be monitored 1-2 months after the start of therapy to determine if your child’s current dose is at the right level. You should know that your doctor should also be measuring your child’s bone age every 6-12 months.

Studies have not been completed in children to determine the full reversibility of fertility suppression.

The most common side effects of LUPRON DEPOT-PED include injection site reactions including abscess, mood swings, acne, vaginitis/vaginal bleeding/vaginal discharge, general pain, rash, headache, and dilation of blood vessels.

For more information, talk with your health care provider.

References: 1. LUPRON DEPOT^® [package insert]. 2. LUPRON DEPOT-PED^® [package insert].