References

  1. Guarnaccia MM, Silverberg K, Olive DL. Endometriosis and adenomyosis. In: Copeland LJ, Jarrell JF, eds. Textbook of Gynecology. 2nd ed. Philadelphia, PA: WB Saunders Co; 2000:687-722.
  2. Lupron Depot 3.75 mg and –3 Month 11.25 mg [package insert]. North Chicago, IL: Abbott Laboratories.
  3. Electronic Orange Book. FDA/Center for Drug Evaluation and Research Web site. Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ucm129662.htm. Accessed January 2010.
  4. Data on file, Abbott Laboratories.
  5. ACOG Education Pamphlet AP013: Endometriosis. Washington, DC: The American College of Obstetricians and Gynecologists; September 2008. ISSN 1074-8601.
  6. Olive DL, Schwartz LB. Endometriosis. N Engl J Med. 1993;328:1759-1769.
  7. Olive DL. Gonadotropin-releasing hormone agonists for endometriosis. N Engl J Med. 2008;359:1136-1142.
  8. Frye CA. An overview of oral contraceptives: mechanism of action and clinical use. Neurology. 2006;66 (suppl 3):S29-S36.
  9. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin, Number 11: Medical Management of Endometriosis. December 1999.
  10. Muzii L, Marana R, Caruana P, et al. Postoperative administration of monophasic combined oral contraceptives after laparoscopic treatment of ovarian endometriomas: a prospective randomized trial. Am J Obstet Gynecol. 2000;183:588-592.
  11. National Institute of Child Health & Human Development. Facts About Endometriosis. Washington, DC: US Dept of Health and Human Services, National Institutes of Health; 1991. NIH publication 91-2413.
  12. Tulandi T. Reproductive surgery. In: Copeland LJ, Jarrell JF, eds. Textbook of Gynecology. 2nd ed. Philadelphia, PA: WB Saunders Co; 2000:383-400.
  13. Martin DC, Hubert GD, Levy BS. Depth of infiltration of endometriosis. J Gynecol Surg. 1989;5:55-60.
  14. Koninckx PR, Martin DC. Deep endometriosis: a consequence of infiltration or retraction or possibly adenomyosis externa? Fertil Steril. 1992;58:924-928.
  15. Murphy AA, Green WR, Bobbie D, et al. Unsuspected endometriosis documented by scanning electron microscopy in visually normal peritoneum. Fertil Steril. 1986;46:522-524.
  16. Winkel CA, Bray M. Use of leuprolide acetate in combination with surgical treatment for women with endometriosis. In: Minaguchi H, Sugimoto O, eds. Endometriosis Today, Advances in Research and Practice: The Proceedings of the Vth World Congress on Endometriosis, Yokohama, Japan, October, 1996. New York, NY: Parthenon Publishing Group; 1997:365-369.
  17. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin, Number 51: Chronic Pelvic Pain. March 2004.
  18. Lupron Depot 3.75 mg and –3 Month 11.25 mg [patient information]. North Chicago, IL: Abbott Laboratories.

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

*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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