Add-back* therapy

By suppressing hormones such as estrogen, Lupron Depot can help manage your endometriosis symptoms. This reduction in estrogen can cause side effects such as hot flashes and bone density loss. Add-back* can help you to experience fewer hot flashes and reduce bone density loss.

You should NOT take 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. Also, you should 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.

Add-back* is a once-a-day pill that adds back low levels of progestin without affecting the effectiveness of Lupron Depot.

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg and – 3 Month 11.25 mg is 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.

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. Condoms, a diaphragm with contraceptive jelly, or an IUD is required to prevent pregnancy. Thinning of the bones, which may not be completely reversible, can occur during treatment with this drug. Norethindrone acetate used as add-back therapy with LUPRON DEPOT has additional serious risks and considerations.

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

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

Experience fewer hot flashes with Add-back*.

Add-back* can help you to experience fewer hot flashes that can be associated with Lupron Depot.

In a clinical study, at Month 6, the group of patients taking Lupron Depot and Add-back* experienced:

Help reduce bone loss with Add-back*.

Thinning of the bones may occur with Lupron Depot alone which may not be completely reversible in some patients. Add-back* can reduce the bone density loss that can be associated with the use of Lupron Depot.

*Norethindrone acetate 5 mg daily

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

For prescription use only.

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.

LUPRON DEPOT given with norethindrone acetate may lower your HDL-cholesterol level (the “good” cholesterol). You should not take norethindrone acetate 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 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, epilepsy, 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 repeat treatment with LUPRON DEPOT alone is not advisable if you have these conditions.

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/or the occurrence of forgetfulness.

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

This is the most important information to know about LUPRON DEPOT. For more information, talk with your health care provider.

Use

LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg and –3 Month 11.25 mg is 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.

Reference: LUPRON DEPOT 3.75 mg and –3 Month 11.25 mg [package insert]. North Chicago, IL: Abbott Laboratories.

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

201-264119