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Add-Back Therapy

While treatment with Lupron Depot® can manage your endometriosis symptoms, lowered hormone levels can cause you to experience temporary side effects such as bone density loss and hot flashes. There is good news. With add-back therapy, you can help to minimize these common side effects of Lupron Depot.

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What is add-back therapy?

If your doctor prescribes Lupron Depot to manage your endometriosis, add-back therapy may also be included as part of your treatment program. Add-back therapy is a pill (norethindrone acetate 5 mg daily) that adds back low levels of a hormone without interfering with the effectiveness of Lupron Depot. It significantly reduces the bone density loss associated with the use of Lupron Depot. It can also help reduce hot flashes.

Add-back therapy can be given with an initial six-month course of Lupron Depot therapy. If an additional course of Lupron Depot is necessary, add-back therapy should be included in the treatment regimen. Lupron Depot lowers the levels of female hormones in your body and interrupts your monthly cycle. When you have endometriosis, reducing the hormone levels can be beneficial. However, lower hormone levels may cause side effects, including bone density loss and hot flashes.

Benefits of add-back therapy

Clinical studies have shown that taking norethindrone acetate 5 mg daily as add-back therapy while using Lupron Depot can help manage these side effects. Add-back therapy works by counteracting some of the effects of decreased hormone levels in your body. The benefits of add-back therapy may include:

  • A significant decrease in bone density loss
  • A reduction in the frequency of hot flashes you have each day, as well as a decline in the number of days you have hot flashes
  • No decrease in the effectiveness of Lupron Depot in relieving the pain associated with endometriosis

When to consider add-back therapy

When discussing Lupron as a treatment option, make sure to talk with your doctor about whether add-back therapy is appropriate for you.

If bone density loss is a particular concern, or if your family has a history of osteoporosis, talk with your doctor about add-back therapy. If you are concerned about hot flashes, tell your doctor.

If your pain returns after completing Lupron Depot therapy alone, your doctor may prescribe Lupron Depot plus add-back therapy for an additional 6 months.

Please see below for important information on Lupron Depot®, including side effects.

*Norethindrone acetate 5mg daily


 
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Important Safety and Other Information:

Lupron Depot® is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Lupron Depot with norethindrone acetate 5 mg daily is also indicated for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.

Most common side effects with Lupron Depot are generally those related to low estrogen levels, including hot flashes, headaches, and vaginal dryness. A small amount of bone loss (average 3.2% at month 6) may also occur during therapy with Lupron Depot alone.

The most commonly reported side effects of Lupron Depot plus norethindrone acetate 5 mg daily are hot flashes, headache, nausea/vomiting, depression/emotional liability, and asthenia. In addition, Lupron Depot plus norethindrone acetate-treated patients had significantly decreased HDL levels and significantly increased LDL/HDL rations. After treatment, mean serum lipid levels in patients with follow-up data returned to pretreatment values. Norethindrone acetate should be used with caution in women with cardiovascular risk factors including lipid abnormalities and cigarette smoking. Please refer to the norethindrone acetate prescribing information for warnings, precautions, contraindications, and adverse reactions.

Please see Complete Prescribing Information, as well as the Patient Product Information for Lupron Depot.

 
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