INDICATIONS ZOLADEX (goserelin implant) is a Gonadotropin Releasing Hormone (GnRH) agonist. ZOLADEX 3.6 mg is indicated for:
•
Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women
•
The management of endometriosis
•
Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding
ZOLADEX 3.6 mg and ZOLADEX 10.8 mg are indicated for:
•
Use in combination with flutamide for the management of locally confined carcinoma of the prostate
•
Palliative treatment of advanced carcinoma of the prostate
IMPORTANT SAFETY INFORMATION
GENERAL
Systemic hypersensitivity, antibody formation, and acute anaphylactic reactions have been reported in patients receiving ZOLADEX. ZOLADEX is contraindicated in patients with known hypersensitivity to GnRH, GnRH agonist, or any of the components in ZOLADEX.
Tumor Flare Phenomenon: Transient worsening of tumor symptoms may occur in the first few weeks of therapy in patients being treated for cancer. Monitor patients at risk for complications of tumor flare including ureteral obstruction, spinal cord compression, and increased bone pain.
Hypercalcemia has been reported in patients with bone metastases treated with ZOLADEX. Monitor and manage appropriately.
Injection site injury and vascular injury have been reported with ZOLADEX. Extra care should be taken when administering ZOLADEX to patients with low BMI and/or to patients receiving full dose anticoagulation.
FEMALES
ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. If used during pregnancy, the patient should be advised of the potential hazard to the fetus. Otherwise, pregnancy must be excluded and effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy.
ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation.
Depression may occur or worsen in women receiving GnRH agonists, including ZOLADEX. Monitor and manage appropriately.
MALES
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose levels and manage according to current clinical practice.
Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. Patients should be monitored for cardiovascular disease and be managed according to current clinical practice.
Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits.
ADVERSE REACTIONS
In men, the most common adverse reactions (>10%) include hot flashes, sexual dysfunction, decreased erections and lower urinary tract symptoms.
In women, the most common adverse reactions (>20%) include hot flashes, vaginitis, headache, emotional lability, decreased libido, sweating, depression, acne, breast atrophy, seborrhea, and peripheral edema.
For cost information for Colorado prescribers, please click here.
For cost information for Connecticut prescribers, please click here.
GnRH=gonadotropin-releasing hormone
*As of July 11, 2025 †According to ClinicalTrials.gov, 139studies have been registered that included goserelin or goserelin acetate and an evaluation of breast cancer outcomes. The first posted data was in 2003. Criteria included all ages, all sexes, regardless of menopausal status. The same search criteria found 52studies with leuprolide or leuprolide acetate (first posted data in 2003) and 30
studies with triptorelin or triptorelin pamoate (first posted data in 2003).
References: 1. ZOLADEX® (goserelin implant) 3.6 mg. Prescribing Information. TerSera Therapeutics LLC. 2. LUPRON DEPOT® (leuprolide acetate for depot suspension). Prescribing Information. AbbVie Inc. 3. ELIGARD® (leuprolide acetate). Prescribing Information. Tolmar Pharmaceuticals Inc. 4. TRELSTAR
® (triptorelin pamoate for injectable suspension). Prescribing Information. Verity Pharmaceuticals, Inc. 5. Data on file. TerSera Therapeutics LLC. 6. Loibl S, Turner NC, Ro J, et al. Palbociclib combined with fulvestrant in premenopausal women with advanced breast cancer and prior progression on endocrine therapy: PALOMA-3 results. Oncologist.
2017;22(9):1028-1038. 7. Lu YS, Im SA, Colleoni M, et al. Updated overall survival of ribociclib plus endocrine therapy versus endocrine therapy alone in pre- and perimenopausal patients with HR+/HER2- advanced breast cancer in MONALEESA-7: a phase III randomized clinical trial. Clin Cancer Res. 2022;28(5):851-859. 8. VERZENIO® (abemaciclib). Prescribing Information. Eli Lilly and Company.
This content is sponsored by TerSera Therapeutics LLC, and ION Oncology Practice Network has not independently reviewed or verified the information provided by TerSera Therapeutics LLC.
This email was sent to karleigh.bard-marsh@cencora.com because you have an account with or are a valued partner of Cencora Specialty GPOs | ION Oncology Practice Network. If you no longer wish to receive these types of emails, please click here to unsubscribe or update your email preferences.
