What is Lupron Depot + Add-back* therapy?

Lupron Depot is an injection given by your healthcare professional. Lupron Depot is used to treat endometriosis, which includes helping to reduce lesions and helping to relieve the pain of endometriosis. It has been prescribed for relief from the symptoms of endometriosis for many women since 1990. Lupron Depot is a 6-month treatment with two dosing options:

  • injected once every 3 months (11.25 mg)
  • injected once each month (3.75 mg)

Along with Lupron Depot, your doctor can prescribe Add-back*, a daily pill that adds back a small amount of hormone. This can help you to experience fewer hot flashes and reduce bone density loss that can be associated with Lupron Depot therapy. This additional treatment may be prescribed from Day 1 of initial treatment with Lupron Depot.

It is important to discuss the risks and benefits of Add-back* therapy with your doctor. Thinning of the bones can occur with Lupron Depot therapy and may not be completely reversible in some patients. Let your doctor know if you have heart or liver disease, if you smoke or have migraines, or if you have had blood clots, a stroke or depression, as these can increase your risk of serious complications.

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.

How long can I take Lupron Depot + Add-back*?

It is important that you stay on your initial course of Lupron Depot for a full 6 months.

  • In one study, after a full 6-month course of Lupron Depot therapy alone, more than half of the endometriosis patients experienced no pelvic pain when followed up 1 year after starting therapy.

Your doctor can prescribe an additional 6 months of treatment along with Add-back* therapy for effective pain relief. This additional treatment may be prescribed if your symptoms of endometriosis recur following your initial course of Lupron Depot therapy. At this time, your doctor should assess your bone density. Be sure to discuss this with your doctor. You should also know that retreatment should be limited to 6 months. The decision to retreat is a medical decision made by your doctor for your condition.

*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.

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