Zoladex® (goserelin acetate implant)

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A woman with endometriosis A woman with endometriosis

Understanding your condition

Endometriosis can be a confusing condition, especially because there is no known cause. Your doctor may have prescribed a number of treatments, including Zoladex. As you move forward with the treatment plan designed by your health care team, it may help to learn more about your disease.

Endometriosis5

Endometriosis is a condition that affects your 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 fallopian tubes.

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. This may end up being a painful process.

There is no known cause for endometriosis. These growths of endometriosis are not cancerous, but they can cause problems for you. Some hormone treatments greatly reduce the amount of estrogen in your body so that your period stops and endometrial tissue doesn’t grow or shed. In some cases, surgery to destroy the excess tissue may be needed (called endometrial ablation). Before the surgery, hormone therapy can help thin the tissue in preparation for the procedure.1

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References
  1. ZOLADEX® (goserelin acetate implant) [prescribing information]. Lake Forest, IL: TerSera Therapeutics LLC; 2017.
  2. Referenced with permission from the NCCN Guidelines for Patients, Breast Cancer. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed December 18, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2018. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed December 18, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  4. Referenced with permission from the NCCN Guidelines for Patients, Prostate Cancer. © National Comprehensive Cancer Network, Inc 2018. All rights reserved. Accessed December 28, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
  5. Mayo Clinic. Endometriosis diagnosis and treatment. https://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/drc-20354661. Accessed January 14, 2019.

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
  • Temporary worsening of symptoms of prostate or breast cancer including bone pain may sometimes develop during the first few weeks of ZOLADEX treatment. Also, rare cases of urinary tract blockage or spinal cord compression have been seen in men being treated for prostate cancer. Your doctor will monitor your condition closely for the first month of treatment
  • In women, menstruation should stop with effective doses of ZOLADEX. Notify your doctor if regular menstruation persists
  • In men, there is an increased risk for developing diabetes or worsening of glucose control, if you already have diabetes, if you are treated with drugs like ZOLADEX
  • In men, there is a small increased risk of heart attack, sudden cardiac death, and stroke if you are treated with drugs like ZOLADEX
  • 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
  • In men, the most common side effects are those related to a loss of testosterone. Those seen are hot flashes, sexual dysfunction, decreased erections, pain, urinary tract symptoms, enlarged breasts, body weakness, upper respiratory infection, and loss of appetite

Approved Uses for ZOLADEX

  • ZOLADEX is approved by the FDA for use in combination with another drug, flutamide, for the management of Stage T2b-T4 (Stage B2-C) prostate cancer. Treatment with ZOLADEX and flutamide should start 8 weeks before the start of radiation therapy and continue during radiation therapy.
  • ZOLADEX is also approved by the FDA to lessen or relieve symptoms in patients with advanced prostate cancer.
  • ZOLADEX is approved by the FDA to lessen or relieve symptoms of HR+ advanced breast cancer in premenopausal and perimenopausal women. Estrogen and progesterone receptor values may help predict whether ZOLADEX therapy is likely to be beneficial.
  • 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 (i.e., the endometrium) before a procedure that destroys this lining (a process called endometrial ablation), which helps with extreme uterine bleeding.

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 or contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.