Prescribing Information

LUPRON DEPOT-PED Prescribing Information

For detailed information on LUPRON DEPOT-PED, please see the link below. If you have any questions, please ask your doctor.

pdf LUPRON DEPOT-PED (leuprolide acetate for depot suspension)

LUPRON DEPOT Prescribing Information

For detailed information on LUPRON DEPOT, please see the link below. If you have any questions, please ask your doctor.

pdf LUPRON DEPOT (leuprolide acetate for depot suspension)

LUPRON DEPOT Prescribing Information

For detailed information on LUPRON DEPOT, please see the links below. If you have any questions, please ask your doctor.

pdf LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) pdf LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension)

LUPRON DEPOT Prescribing Information

For detailed information on LUPRON DEPOT, please see the links below. If you have any questions, please ask your doctor.

pdf LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) pdf LUPRON DEPOT 11.25 mg (leuprolide acetate for depot suspension)
USES

Endometriosis

Taking LUPRON DEPOT Alone

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg or 11.25 mg is used for the management of endometriosis, including pain relief and reduction of endometriotic lesions.

Taking LUPRON DEPOT in Combination with Norethindrone Acetate

LUPRON DEPOT 3.75 mg or 11.25 mg in combination with norethindrone acetate is used for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 3.75 mg or 11.25 mg is referred to as add-back therapy, and is intended to reduce the thinning of bone and reduce hot flashes associated with use of LUPRON DEPOT 3.75 mg or 11.25 mg.

Limitations of Use

The total duration of therapy with LUPRON DEPOT 3.75 mg or 11.25 mg plus add-back therapy should not exceed 12 months due to concerns of bone thinning.

Uterine Fibroids

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg or 11.25 mg with iron therapy is used before fibroid surgery to improve anemia due to vaginal bleeding from fibroids for patients in whom 3 months of hormonal suppression is deemed necessary. The duration of therapy with LUPRON DEPOT is limited to 3 months. The symptoms associated with fibroids will return after stopping therapy.

Your doctor may consider a 1-month trial of iron alone, as some women will respond to iron alone. LUPRON DEPOT 3.75 mg or 11.25 mg may be added if the response to iron alone is considered inadequate.

Limitations of Use

LUPRON DEPOT 3.75 mg or 11.25 mg is not used in combination with norethindrone acetate add-back therapy before fibroid surgery to improve anemia due to vaginal bleeding from fibroids.

Advanced 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 treatment of advanced prostate cancer. LUPRON DEPOT is a prescription medication that must be administered in your doctor’s office.

Central Precocious Puberty (CPP)

LUPRON DEPOT-PED® (leuprolide acetate for depot suspension) is an injectable prescription gonadotropin-releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP). It is not known if LUPRON DEPOT-PED is safe and effective in children under 2 years of age.

IMPORTANT SAFETY INFORMATION

General Information

Safety Information for Use in Endometriosis or Uterine Fibroids

Safety Information for Use in Advanced Prostate Cancer

Safety Information for Use in Central Precocious Puberty

This is the most important information to know about LUPRON DEPOT and LUPRON DEPOT-PED. For more information, talk to your doctor or healthcare provider.

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.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.