Prescribing Information

CHILDREN Central Precocious Puberty

Lupron Depot-PED Prescribing Information

For detailed information on Lupron Depot-PED, click on the link below. If you have any questions, please ask your doctor.

Lupron Depot-PED PDF
(leuprolide acetate for depot suspension)

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WOMEN Endometriosis

Lupron Depot Prescribing Information

For detailed information on Lupron Depot, click on a link below. If you have any questions, please ask your doctor.

Lupron Depot 3.75 mg PDF
(leuprolide acetate for depot suspension)

Lupron Depot –3 Month 11.25 mg PDF
(leuprolide acetate for depot suspension)

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WOMEN Fibroids

Lupron Depot Prescribing Information

For detailed information on Lupron Depot, click on a link below. If you have any questions, please ask your doctor.

Lupron Depot –3 Month 11.25 mg PDF
(leuprolide acetate for depot suspension)

Lupron Depot 3.75 mg PDF
(leuprolide acetate for depot suspension)

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MEN Prostate Cancer

Lupron Depot Prescribing Information

For detailed information on Lupron Depot, click on a link below. If you have any questions, please ask your doctor.

LUPRON DEPOT® (leuprolide acetate for depot suspension) URO

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Uses1,2

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 1-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 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 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 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 for 1-month and 11.25 mg and 30 mg for 3-month administration are prescribed 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. The doctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors).

Important Safety Information1,2

General Information

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 or LUPRON DEPOT-PED.

Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.

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

Fibroids

Thinning of the bones may occur during therapy with LUPRON DEPOT, 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.

Endometriosis

Thinning of the bones may occur during therapy with LUPRON DEPOT, 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.

You should not take norethindrone acetate with LUPRON DEPOT if you currently have or have previously had any clotting disorder, heart disease, stroke, impaired liver function or liver disease, or breast cancer.

Tell your healthcare provider before beginning treatment with norethindrone acetate if you currently have or have previously had high cholesterol, migraines, epilepsy, or depression, or 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, seizure, 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.

Advanced Prostate Cancer

LUPRON DEPOT 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 prostate-specific antigen (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.

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, gastrointestinal, and respiratory problems.

Central Precocious Puberty (CPP)

During the first weeks of LUPRON DEPOT-PED treatment, signs of puberty, such as vaginal bleeding, may occur. This is a common initial effect of the drug. The doctor should be notified if signs/symptoms of puberty continue beyond the second month of treatment.

Your child’s initial response to LUPRON DEPOT-PED should be monitored, as well as their continued response during treatment, as clinically needed. If your child receives a 1-month injection, response is assessed 1-2 months after the initial injection. If your child receives a 3-month injection, response is assessed 2-3 months after the initial injection and at month 6. Height and bone age should be checked every 6-12 months in children using LUPRON DEPOT-PED.

It is important for children to keep doctor appointments and follow the prescribed injection schedule. Pubertal development could begin again if injections are missed.

The most frequent adverse reactions of LUPRON DEPOT-PED were pain; acne; injection site reactions, including pain, swelling, and abscess; rash, including a painful rash with fever, blisters/sores, and facial swelling; vaginitis/vaginal bleeding/vaginal discharge; increased weight; and altered mood. The most common side effects for any GnRH agonist, including LUPRON DEPOT-PED, are injection site reactions/pain including abscess, general pain, headache, fluctuating emotions, and hot flushes/sweating.

After the injection, some pain and irritation is expected; however, if more severe symptoms occur or if any new, unusual, or worsened symptoms develop, contact the doctor.

LUPRON DEPOT-PED is not for children under 2 years of age.

For more information, talk with your healthcare provider.

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