In the treatment of endometriosis

ZOLADEX
supports you.

If you have endometriosis, and have discussed ZOLADEX as a treatment option with your doctor, learn more here.

What is endometriosis?

Endometriosis is a condition that affects a woman’s uterus (the womb where a baby grows during pregnancy). The lining of the uterus is a type of tissue called the endometrium. Sometimes this lining tissue grows in areas outside of the uterus—like on the ovaries, behind the uterus, or on the bowels or bladder. The tissue that has grown outside of the uterus responds the same as the tissue inside. That means every month, when the hormone estrogen causes the lining of the uterus to build up, the tissue in surrounding areas will also build up. When the uterus sheds tissue and blood through the vagina as a menstrual period, the tissue in other areas also tries to shed, but the only place it can go is into the body—a painful process.

There is no known cause for endometriosis. These growths of endometriosis are not cancerous, but they can cause problems. Hormone treatment greatly reduces the amount of estrogen in your body so that your period is stopped and endometrial tissue doesn’t grow or shed. In some cases, surgery to destroy the excess tissue is needed (called endometrial ablation). Before the surgery, hormone therapy can help to thin the tissue in preparation for the procedure.

FAQs about ZOLADEX

Here are answers to frequently asked questions about ZOLADEX therapy for endometriosis. These answers may help you better understand what ZOLADEX is, how it works, and what you may expect from your therapy.

ZOLADEX is a prescription medication that is approved for the management of endometriosis, including pain relief and reducing endometrial lesions, for 6 months of therapy.

ZOLADEX is also indicated to thin the lining of the uterus (ie, the endometrium) before a procedure that destroys this lining (a process called endometrial ablation), which helps with extreme uterine bleeding. Because ZOLADEX may make the cervix more resistant to dilation, your doctor will dilate the cervix carefully before endometrial ablation.

Do not begin ZOLADEX if you have abnormal vaginal bleeding that is undiagnosed or if you are allergic to any of the ingredients of ZOLADEX. You should not receive ZOLADEX if you are pregnant, could become pregnant, or are nursing.

Please see Important Safety Information below.

ZOLADEX is a gonadotropin-releasing hormone agonist, or GnRH-A. It is an implant that is injected every month under the skin (subcutaneously). The implant gradually dissolves and releases the drug over the time between injections.

The rise and fall of hormones, like estrogen, during the menstrual cycle cause endometrial lesions to thicken, break down, and bleed during menstruation. The majority of estrogen is produced by the ovaries. A GnRH-A, like ZOLADEX, is used to prevent estrogen production by the ovaries, which prevents menstruation. Without estrogen, the growth of endometrial tissue will slow down and may shrink.

The most commonly reported side effects in women being treated with ZOLADEX for endometriosis and endometrial thinning were related to a decrease in estrogen levels. The most commonly reported side effects with ZOLADEX in clinical trials for endometriosis were hot flashes, vaginitis, headache, decreased libido, extreme emotions, depression, sweating, acne, shrinkage of breasts, a skin condition called seborrhea, and swelling due to accumulation of fluid.

The most commonly reported side effects with ZOLADEX in clinical trials for endometrial thinning were widening of blood vessels/hot flashes, headache, sweating, and abdominal pain.

GnRH is an abbreviation for gonadotropin-releasing hormone. Both men and women have GnRH, which controls sex hormones. “A” stands for “agonist.” An agonist is a pharmaceutical compound that behaves in a similar way to a natural compound in the body. ZOLADEX is a GnRH agonist that mimics GnRH to help control the hormone estrogen.

A reduction in bone mineral density has been reported in women who take ZOLADEX and drugs that work the same way as ZOLADEX. Current data suggest that most patients will recover bone loss when therapy is stopped.

Menstruation should stop with effective doses of ZOLADEX. Notify your doctor if you continue to menstruate. Menses usually resumes within 8 weeks after therapy is completed. Some patients may have a delay in resuming their menses. Rarely will a patient have their menses not return.

During the first 2 months of ZOLADEX use, some women experience temporary vaginal bleeding. This bleeding is not a menses. It is likely due to decreasing estrogen.

ZOLADEX is injected by a doctor just under the skin (subcutaneously) in the lower abdominal area below the navel (belly button). The implant gradually dissolves and releases the drug over the time between injections.

ZOLADEX 3.6 mg is administered once a month (every 28 days).

It is very important for you to get your injections as your doctor schedules to keep ZOLADEX levels consistently high enough to block estrogen production. Keep in mind that although a delay of a few days is permissible, every effort should be made to adhere to the dosing schedule your doctor has recommended. Patients who miss one or more doses in a row may have breakthrough bleeding.

If you need to be out of town when you are scheduled for a ZOLADEX injection, ask your doctor to help you arrange to receive your injection at a medical facility near where you will be staying. A few days late may be okay, but it’s important to stick to your overall injection schedule.

Adding HRT to treatment with ZOLADEX can help relieve vaginal dryness and bone mineral loss. HRT will not affect how ZOLADEX works.

Please talk to your doctor if you have questions about ZOLADEX.

Read full Prescribing Information for ZOLADEX 3.6 mg

Support resources for endometriosis

The following list of resources is provided as a convenience to you. AstraZeneca takes no responsibility for the content of, or services provided by, these resources and makes no representation as to the accuracy or completeness of any information provided by these resources. AstraZeneca shall have no liability for any damage or injuries of any kind arising from the information provided by the resources listed. The descriptions of the organizations are directly from their respective Web sites.

www.endofound.org

The Endometriosis Foundation of America strives to increase disease recognition, provide advocacy, facilitate expert surgical training, and fund landmark endometriosis research. It places particular emphasis on the critical importance of early diagnosis and effective intervention while providing education to the next generation of medical professionals and their patients.

Phone: 212-988-4160

www.endometriosis.org

Endometriosis.org delivers up-to-date, evidence-based information and news about endometriosis, and provides knowledge to empower women to make informed decisions about their treatment options. There is no contact information for this organization. The site is an information resource.

3107506 Last Updated 9/15

Important Safety Information About ZOLADEX

  • If you are pregnant, ZOLADEX can cause harm to your unborn child. You should not receive ZOLADEX if you are pregnant, could become pregnant, or are nursing unless you are being treated to relieve symptoms of advanced breast cancer
  • In both men and women ZOLADEX should not be administered if you are allergic to it, to any of its ingredients, or to similar hormone therapies
  • In women menstruation should stop with effective doses of ZOLADEX. Notify your doctor if regular menstruation persists
  • Injection site injury has been reported following injection of ZOLADEX. Contact your doctor immediately if you experience any of the following symptoms: abdominal pain, abdominal bloating, shortness of breath, dizziness, light-headedness and/or any signs of confusion
  • In women the most common side effects are those resulting from reduction of estrogen. Those seen are hot flashes (flushes), headaches, vaginal dryness, emotional lability, change in libido, depression, sweating, and change in breast size
Approved Uses for ZOLADEX

  • ZOLADEX is indicated for the management of endometriosis, including pain relief and reducing endometrial lesions, for 6 months of therapy.
  • ZOLADEX is also approved to thin the lining of the uterus (ie, the endometrium) before a procedure that destroys this lining (a process called endometrial ablation), which helps with extreme uterine bleeding.

Read full Prescribing Information for ZOLADEX 3.6 mg 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

This site is intended for US consumers only.

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about ZOLADEX, talk to your doctor or pharmacist. Only you and your health care professional can decide if ZOLADEX is right for you.