Zoladex® (goserelin acetate implant)

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A woman with HR+ breast cancer A woman with HR+ breast cancer

Understanding your condition

Receiving a cancer diagnosis can be very difficult for you and your family. 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.

Premenopausal HR+ breast cancer2

Hormone-receptor-positive (or HR+) advanced breast cancer is one type of advanced breast cancer. If your breast cancer cells show a significant number of receptors for either estrogen or progesterone, then it is described as HR+ breast cancer. This diagnosis suggests that the cells receive signals from either estrogen or progesterone to continue growing.

If your breast cancer is HR+, blocking estrogen will likely be a key part of your breast cancer treatment plan. The types of estrogen-blocking medicines that may work best for you depend on whether you are premenopausal or postmenopausal.

If you are premenopausal, your ovaries make a lot of estrogen, so they are the main source of estrogen in your body. If you are postmenopausal, your ovaries no longer make a lot of estrogen, but small amounts of estrogen are still being made in other places in your body. Because medicines for blocking estrogen work differently from one another, your doctor will consider this important factor when recommending the treatments that are right for you.2

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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.