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1. Lupron Depot, a GnRH agonist, is effective for endometriosis. After completing a full 6-month course of therapy, 99% of patients reported improved relief of painful periods (dysmenorrhea), 77% reported improved relief of pelvic tenderness, and 70% reported improved relief of pelvic pain. 2. Treatment with Lupron Depot lasts. Symptom relief can extend well beyond the treatment period for many women. For example, 12 months after the end of Lupron Depot therapy, 76% of patients previously reporting painful sexual intercourse (dyspareunia) were still symptom-free. Of women who had pelvic tenderness before using Lupron Depot, 61% were symptom-free after a year. Over half of women with pelvic pain with menstruation (dysmenorrhea) were symptom-free a year after Lupron Depot therapy. 3. Lupron Depot therapy can actually shrink the endometriotic implants that have been causing pain in your abdomen. In clinical studies, women with pelvic pain underwent diagnostic laparoscopy before and after they were treated with Lupron Depot for 6 months. In the women in whom surgeons could actually see endometriotic lesions and implants, the surgeons observed that a full course of Lupron Depot therapy had substantially reduced the size of the endometrial implants. 4. Many women with endometriosis experience pain relief within the first 3 months of Lupron Depot therapy. In order to determine whether or not Lupron Depot is going to work for you, your physician may recommend a trial of therapy for 3 months. Many patients can tell within that period of time whether or not Lupron Depot will work to control their pelvic pain. If it is working for you, your physician may have you complete the entire 6-month regimen to ensure the longest period of pain relief possible. 5. Just 6 months of therapy can mean years of pain relief. While a course of GnRH agonist therapy is for 6 months, many women report pain relief for up to 5 years after they have finished therapy. In fact, in clinical trials, 63% of patients with mild disease reported being symptom-free 5 years after the end of GnRH agonist therapy, and 26% of patients with severe disease reported being symptom-free. 6. Lupron Depot is well tolerated. Lupron, like any of the other drugs in its class that are used for endometriosis, works by putting your body into a temporary state of menopause, so most side effects of Lupron Depot therapy are similar to what women experience during menopause. These can include hot flashes, headaches, stopped periods, and vaginal dryness. These symptoms were temporary and reversible in patients during clinical trials. Many patients have established ways of tolerating side effects, most notably hot flashes, in much the same way women going through the first stages of menopause have learned to cope with their symptoms. Examples include dressing in layers that can be easily removed, avoiding hot drinks and spicy foods that can trigger hot flashes, and using waterproof mascara to prevent makeup from running. 7. Side effects you may experience when taking Lupron Depot therapy usually disappear when you stop taking it. A course of Lupron Depot therapy for endometriosis is 6 months, yet many women experience pain relief for many years afterward. Side effects that may (or may not) be experienced during the 6 months of therapy should diminish soon after therapy ends. For example, your monthly period should return within two months after you've stopped Lupron Depot, and bone mineral loss experienced during therapy may be partially or completely recovered after you stop taking Lupron Depot. 8. Bone mineral loss experienced with 6 months of Lupron Depot therapy is actually lower than that experienced after breastfeeding an infant. Menopause can involve bone mineral loss that can eventually lead to osteoporosis, but the menopausal state achieved by Lupron Depot therapy is temporary, and can result in a small amount of bone mineral loss in some patients. After 6 months of therapy, vertebral bone density decreased by an average of 3.2%, compared with the pretreatment value. This effect may be partially or completely recovered after you stop taking Lupron Depot. To put this in perspective, clinical studies have shown that women who breastfeed 6 months or longer experience bone mineral density losses of an average of 5%. 9. There may be side effects with every medical treatment prescribed for endometriosis. As with any drug, side effects are possible but not always experienced. In the case of drugs that are prescribed for endometriosis, the following side effects are prevalent as described in the approved package insert for these drugs: Oral Contraceptives: Nausea, vomiting, abdominal cramps and bloating, breakthrough bleeding, spotting Anti-inflammatories: Constipation, heartburn, abdominal pain, headache, dizziness, ulcers Progestins, like danazol: Hot flashes, weight gain, depression, headache, acne GnRH agonists, like Lupron Depot, Zoladex®*, Synarel®*: Hot flashes, headache, vaginitis, depression, general pain *Zoladex® (goserelin acetate) is a registered trademark of Zeneca Pharmaceuticals. *Synarel® (nafarelin acetate) is a registered trademark of G.D. Searle & Co. 10. Overall, Lupron Depot therapy is associated with a lower incidence of side effects than danazol. In two clinical trials with 166 endometriosis patients, side effects were compared between patients receiving Lupron Depot therapy and danazol. The following summarizes the studies' findings: Adverse Events Reported to Be Causally Related to Drug in 5% of Patients Endometriosis (2 Studies) LUPRON DEPOT 3.75 mg Danazol Placebo (sugar pill) N=166 N=136 N=31 N (%) N (%) N (%) Body as a Whole ...Asthenia 5 (3) 9 (7) 0 (0) ...General pain 31 (19) 22 (16) 1 (3) ...Headache* 53 (32) 30 (22) 2 (6) Cardiovascular System ...Hot flashes/sweats* 139 (84) 77 (57) 9 (29) Gastrointestinal System ...Nausea/vomiting 21 (13) 17 (13) 1 (3) ...GI disturbances* 11 (7) 8 (6) 1 (3) Metabolic and Nutritional Disorders ...Edema 12 (7) 17 (13) 1 (3) ...Weight gain/loss 22 (13) 36 (26) 0 (0) Endocrine System ...Acne 17 (10) 27 (20) 0 (0) ...Hirsutism 2 (1) 9 (7) 1 (3) Musculoskeletal System ...Joint disorder* 14 (8) 11 (8) 0 (0) ...Myalgia* 1 (1) 7 (5) 0 (0) Nervous System ...Decreased libido* 19 (11) 6 (4) 0 (0) ...Depression/emotional lability* 36 (22) 27 (20) 1 (3) ...Dizziness 19 (11) 4 (3) 0 (0) ...Nervousness* 8 (5) 11 (8) 0 (0) ...Neuromuscular disorders* 11 (7) 17 (13) 0 (0) ...Paresthesias 12 (7) 11 (8) 0 (0) Skin and Appendages ...Skin reactions 17 (10) 20 (15) 1 (3) Urogenital System ...Breast changes/tenderness/pain* 10 (6) 12 (9) 0 (0) ...Vaginitis* 46 (28) 23 (17) 0 (0) *Physiologic effect of the drug. 11. If your doctor performs diagnostic surgery yet does not see any evidence of endometriosis, he or she may still prescribe Lupron Depot for your pelvic pain. Endometriosis isn't always visible to the physician performing diagnostic surgery. Sometimes endometriotic lesions are hidden behind scar tissue, have grown deep into tissue, or are hidden behind other organs in the abdomen. Since pelvic pain is often associated with endometriosis, your doctor may still suggest a trial of Lupron Depot for 3 months. If it works, you will probably continue for the full 6-month drug regimen to ensure a long-lasting effect, keeping you pain-free for the longest time possible. 12. If your doctor performed laparoscopic surgery and removed endometriotic lesions through laser ablation, he or she may still prescribe Lupron Depot for you after your surgery. Not all endometriosis can be seen during laparoscopic surgery. A surgeon is only able to remove whatever endometriotic tissue can be seen during surgery. When endometriotic implants grow deep into the tissues, or are hidden behind other abdominal organs, they cannot be removed without significant risk. So, your physician may recommend a 6-month course of Lupron Depot therapy following your surgery to treat the endometriosis that is missed or hidden, ensuring that you will obtain the best pain relief possible, for the longest period of time. 13. Lupron Depot is the Number One drug in its class prescribed for endometriosis. Of the available agents for endometriosis including Lupron Depot, Zoladex®*, Synarel®*, and danazol, 93% of prescriptions written for endometriosis and uterine fibroids are for Lupron Depot. This is testimony to the efficacy and safety of Lupron Depot, known and trusted by physicians and patients for more than 9 years. *Zoladex® (goserelin acetate) is a registered trademark of Zeneca Pharmaceuticals. *Synarel® (nafarelin acetate) is a registered trademark of G.D. Searle & Co. 14. Often, when birth control pills fail to control your endometriosis, Lupron Depot can work for you. The way birth control pills work is unlike the way Lupron Depot works against endometriosis. If oral contraceptives do not ease or eliminate endometriosis pain, it may be because your endometriosis may not respond to hormonal manipulation. However, the removal of hormones that occurs with Lupron Depot therapy may be just the right approach to control your endometriosis. Discuss your treatment options openly with your physician. 15. For your convenience, there are two different dosage options from which to choose when taking Lupron Depot. Lupron Depot is available as an intramuscular injection that can be given once every 3 months (-3 Month 11.25 mg) or once every month (3.75 mg). Which dosage form you select will determine how often you need to visit your physician's office to receive your injection of Lupron Depot. Together, you and your physician can decide which option is more convenient for you. 16. Lupron Depot (like many other drugs) has been referred to in the medical literature as chemotherapy because it is a chemical and it is used for therapy for a disease. Lupron Depot is NOT among the agents used exclusively for the treatment of cancer, which may cause nausea, vomiting, and/or hair loss. Lupron Depot is among several drugs in a class known as gonadotropin-releasing hormone analogs (or GnRH analogs). These agents work solely by reducing hormone production in the body. Just as Lupron Depot works in women by inhibiting the release of estrogen, the female hormone that fuels endometriosis, it also inhibits the release of testosterone, the male hormone that fuels prostate cancer in men. Hence, it has been found to be useful in limiting the growth of prostate cancer and in alleviating pain in advanced prostate cancer patients. For further information including adverse events about Lupron Depot, please see complete prescribing information or contact the Medical Services Department at 1-800-622-2011. |
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