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 lability, and asthenia. In addition, Lupron Depot plus norethindrone acetate-treated patients had significantly decreased HDL levels and significantly increased LDL/HDL ratios. 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.