PROSTATE

Please see Important Safety Information you should know about Lupron Depot.

ENDOMETRIOSIS

Please see Important Safety Information you should know about Lupron Depot.

FIBROIDS

Please see Important Safety Information you should know about Lupron Depot.

CENTRAL PRECOCIOUS PUBERTY (CPP)

Please see Important Safety Information you should know about Lupron Depot-PED.

MEN Prostate Cancer

• 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 is a prescription medication that must be administered in your doctor’s office.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Safety Considerations

LUPRON DEPOT causes an increase in testosterone during the first few weeks of treatment • An increase in urinary symptoms and/or pain may occur • In patients whose cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can lead to paralysis, which may be life-threatening • High blood sugar and an increased risk for developing diabetes, heart attack, sudden death, and stroke can occur with LUPRON DEPOT treatment • LUPRON DEPOT can affect the heart’s electrical activity in patients with certain heart conditions or abnormal blood tests for electrolytes, or who are taking medications that regulate the heartbeat • Reports of convulsions have occurred in patients taking LUPRON DEPOT with or without a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), or in those taking medicines that cause convulsions • LUPRON DEPOT may cause impotence

Please see additional Important Safety Information you should know about Lupron Depot and discuss it with your doctor.

WOMEN Endometriosis

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration 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 indicated 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.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Safety Considerations

• You should not receive LUPRON DEPOT if you are or may become pregnant, are breast-feeding or have undiagnosed vaginal bleeding • Increased endometriosis symptoms (i.e. pelvic pain or pressure and/or pain during intercourse) may occur for 1 or 2 weeks after starting this drug • Development or worsening of depression has occurred • A condom, a diaphragm with contraceptive jelly, or a copper IUD is required to prevent pregnancy • Thinning of the bones, which may not be completely reversible, can occur during treatment with this drug • Reports of convulsions have occurred in patients taking leuprolide acetate • Norethindrone acetate used as add-back therapy with LUPRON DEPOT has additional serious risks and considerations • See the Important Safety Information section for add-back risks and considerations

Please see additional Important Safety Information you should know about Lupron Depot and discuss it with your doctor.

WOMEN Fibroids

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration 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.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Safety Considerations

• You should not receive LUPRON DEPOT if you are or may become pregnant, are breast-feeding or have undiagnosed vaginal bleeding • Increased fibroid symptoms (i.e. abdominal bloating, pelvic pain or pressure) may occur for 1 or 2 weeks after starting this drug • Development or worsening of depression has occurred • A condom, a diaphragm with contraceptive jelly, or a copper IUD is required to prevent pregnancy • Thinning of the bones, which may not be completely reversible, can occur during treatment with this drug • Reports of convulsions have occurred in patients taking leuprolide acetate

Please see additional Important Safety Information you should know about Lupron Depot and discuss it with your doctor.

CHILDREN Central Precocious Puberty (CPP)

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. Your doctor should perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

Please see the full Prescribing Information for Lupron Depot-PED and discuss it with your doctor.

Safety Considerations

• Your child should not receive LUPRON DEPOT-PED if she/he is allergic to any of the ingredients or she is or may become pregnant • Increased signs and symptoms of puberty during the first few weeks of treatment may occur • Contact your child’s health care provider if signs of puberty continue after the second month of treatment or if new or unusual signs or symptoms occur • Reports of convulsions have occurred in patients taking LUPRON DEPOT-PED with or without a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), or if taking medicines that cause convulsions • Your child’s pubertal development could begin again if the injection schedule is not followed

Please see additional Important Safety Information you should know about Lupron Depot-PED and discuss it with your doctor.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

Click here to return to home

If you or a loved one has been prescribed LUPRON DEPOT,
click on the specific condition to find out more about LUPRON DEPOT therapy

Use and Important Safety Information You Should Know About Lupron Depot® (leuprolide acetate for depot suspension)

Use

  • 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 is a prescription medication that must be administered in your doctor’s office.

Important Safety Information

  • LUPRON DEPOT is not for people who have had any type of allergic reaction to LUPRON DEPOT or similar drugs.
  • LUPRON DEPOT is not for women who are or may become pregnant.
  • 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 on 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.
  • 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 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.

For more information, talk with your healthcare provider.

Please see the complete Prescribing Information for Lupron Depot and discuss it with your doctor.

Reference: LUPRON DEPOT [package insert].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

Click here to return to home

If you or a loved one has been prescribed LUPRON DEPOT,
click on the specific condition to find out more about LUPRON DEPOT therapy

Use and Important Safety Information You Should Know About Lupron Depot® (leuprolide acetate for depot suspension)

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration 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 indicated 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.

Important Safety Information

Do not take LUPRON DEPOT if you are or may become pregnant, are breast-feeding, have undiagnosed vaginal bleeding, or if you have experienced any type of allergic reaction to LUPRON DEPOT, or similar drugs.

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 health care provider before beginning treatment with norethindrone acetate if you currently have or have previously had high cholesterol, migraines, epilepsy, depression, or smoke.

During treatment with LUPRON DEPOT and norethindrone acetate, 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, heart or kidney problems.

Thinning of the bones may occur during therapy with LUPRON DEPOT alone, 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. You should be aware that if you have these conditions, treatment with LUPRON DEPOT alone is not advisable and combination with norethindrone acetate should be considered. If a second course of treatment with LUPRON DEPOT is being considered, bone mineral testing is recommended and retreatment should include combination with norethindrone acetate.

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 a copper 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.

Convulsions have been observed in patients taking leuprolide acetate.

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

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

For more information, talk with your health care provider.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Reference: LUPRON DEPOT [package insert].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

Click here to return to home

If you or a loved one has been prescribed LUPRON DEPOT,
click on the specific condition to find out more about LUPRON DEPOT therapy

Use and Important Safety Information You Should Know About Lupron Depot® (leuprolide acetate for depot suspension)

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1-month and 11.25 mg for 3-month administration 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.

Important Safety Information

Do not take LUPRON DEPOT if you are or may become pregnant, are breast-feeding, have undiagnosed vaginal bleeding, or if you have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs.

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 a copper 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.

Convulsions have been observed in patients taking leuprolide acetate.

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

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

For more information, talk with your health care provider.

Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor.

Reference: LUPRON DEPOT [package insert].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.

Click here to return to home

If you or a loved one has been prescribed LUPRON DEPOT-PED,
click on the specific condition to find out more about LUPRON DEPOT-PED therapy

Use and Important Safety Information You Should Know About Lupron Depot-PED® (leuprolide acetate for depot suspension)

Use

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. Your doctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors).

Important Safety Information

Your child should not receive any formulation of LUPRON DEPOT-PED if he/she has experienced any type of allergic reaction to LUPRON DEPOT‑PED or similar drugs.

Females who are or may become pregnant should not receive any formulation of LUPRON DEPOT‑PED.

During the first weeks of treatment, signs of puberty, such as vaginal bleeding, may occur. This is a common initial effect of the drug. Notify your child’s doctor if signs/symptoms of puberty continue beyond the second month of treatment.

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 patients who are taking medications that have been associated with convulsions. Convulsions have also been reported in patients without any of these conditions.

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 that you keep your child’s doctor appointments and follow the prescribed injection schedule. Your child’s pubertal development could begin again if injections are missed.

The most common side effects with LUPRON DEPOT‑PED and similar drugs are 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; altered mood; 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 your child’s doctor.

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

LUPRON DEPOT‑PED must be administered under the supervision of a physician.

For more information, talk with your child’s health care provider.

Please see the full Prescribing Information for Lupron Depot‑PED and discuss it with your doctor.

Reference: LUPRON DEPOT‑PED [package insert].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) (1-888-477-2669) for assistance.