Zoladex® (goserelin implant)

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References
  1. ZOLADEX® (goserelin implant) [prescribing information]. Deerfield, IL: TerSera Therapeutics LLC; 2020.
  2. Referenced with permission from the NCCN patient Guidelines in Oncology (NCCN Guidelines®) for Invasive Breast Cancer. © National Comprehensive Cancer Network, Inc 2021. All rights reserved. Accessed December 7, 2021. 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.1.2022. © National Comprehensive Cancer Network, Inc 2021. All rights reserved. Accessed December 7, 2021. 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 patient Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer, Advanced Stage. © National Comprehensive Cancer Network, Inc 2021. All rights reserved. Accessed December 7, 2021. 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 September 28, 2021.

Important Safety Information

  • 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 3.6-mg and ZOLADEX 10.8-mg

  • 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 3.6-mg

  • 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.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also contact TerSera Therapeutics at 1-844-334-4035 or medicalinformation@tersera.com.