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Foundational in the care of pre- and perimenopausal women with advanced breast cancer

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Earned trust, one patient at a time

  • 1 AND ONLY GnRH AGONIST with FDA approval for pre- and perimenopausal women with advanced breast cancer and survival data to support its indication1‑5*

  • #1 PRESCRIBED GnRH AGONIST

    in the US for breast cancer6†

  • 1.5+ MILLION DOSES

    administered in breast cancer6‡

    ‡From TerSera launch of ZOLADEX in January 2017 through March 2026.

  • #1 STUDIED GnRH AGONIST

    in breast cancer6§

    145 total studies to date in breast cancer6§

    50 active and/or recruiting studies6§

    All 3 CDK4/6 inhibitors included goserelin in their phase 3 pivotal trials when ovarian function suppression was required7-9

  • *Randomized trial in premenopausal women with HR+ advanced BC, OS was similar between goserelin and oophorectomy, with no statistically significant difference observed (HR 0.80; 95% CI 0.53-1.20; median OS 37 mo vs 33 mo), respectively.
  • †Symphony Health, an ICON plc Company, PatientSource®, January 1, 2024 through July 14, 2026.
  • §According to ClinicalTrials.gov, 145 studies 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 56 studies with leuprolide or leuprolide acetate (first posted data in 2003) and 31 studies with triptorelin or triptorelin pamoate (first posted data in 2003).

Additional ZOLADEX indications include:

Prostate cancer background image
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Treatment of advanced prostate cancer

Learn more
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Endometriosis background image
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Management of endometriosis

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BC=breast cancer; CI=confidence interval; GnRH=gonadotropin-releasing hormone; HR=hazard ratio; HR+=hormone receptor positive; OS=overall survival.

  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. Taylor CW, Green S, Dalton WS, et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol. 1998;16(3):994-999.
  6. Data on file. TerSera Therapeutics LLC.
  7. 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.
  8. 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.
  9. Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZOLADEX is contraindicated in patients with known hypersensitivity to GnRH, GnRH agonist, or any of the components in ZOLADEX.

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.

WARNINGS AND PRECAUTIONS

Women of Childbearing Potential and Pregnancy: Women of childbearing potential should avoid becoming pregnant. ZOLADEX can cause fetal harm. 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. 

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.

Hyperglycemia and Diabetes: 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.

Cardiovascular Diseases: 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.

Hypercalcemia: Hypercalcemia has been reported in some prostate and breast cancer patients with bone metastases. Monitor and manage appropriately.

Hypersensitivity: Systemic hypersensitivity, antibody formation, and acute anaphylactic reactions have been reported in patients receiving ZOLADEX.

Severe Cutaneous Adverse Reactions: ZOLADEX can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). SCARs, including SJS/TEN, DRESS, and AGEP, occurred in patients receiving ZOLADEX or other GnRH agonists, including cases with visceral involvement and/or requiring skin grafts. Monitor patients for the development of SCARs. If a SCAR is suspected, interrupt ZOLADEX until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other grade 4 skin reactions, permanently discontinue ZOLADEX.

Cervical Resistance: ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation.

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits.

Injection Site Injury: 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.

Depression: Depression may occur or worsen in women receiving GnRH agonists, including ZOLADEX. Monitor and manage appropriately. Carefully observe women for depression, especially those with a history and consider if risks outweigh the 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.

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.

Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg.

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, including pain relief and reduction of endometriotic lesions for the duration of therapy
  • 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 and Indications

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZOLADEX is contraindicated in patients with known hypersensitivity to GnRH, GnRH agonist, or any of the components in ZOLADEX.

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.

WARNINGS AND PRECAUTIONS

Women of Childbearing Potential and Pregnancy: Women of childbearing potential should avoid becoming pregnant. ZOLADEX can cause fetal harm. 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. 

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.

Hyperglycemia and Diabetes: 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.

Cardiovascular Diseases: 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.

Hypercalcemia: Hypercalcemia has been reported in some prostate and breast cancer patients with bone metastases. Monitor and manage appropriately.

Hypersensitivity: Systemic hypersensitivity, antibody formation, and acute anaphylactic reactions have been reported in patients receiving ZOLADEX.

Severe Cutaneous Adverse Reactions: ZOLADEX can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). SCARs, including SJS/TEN, DRESS, and AGEP, occurred in patients receiving ZOLADEX or other GnRH agonists, including cases with visceral involvement and/or requiring skin grafts. Monitor patients for the development of SCARs. If a SCAR is suspected, interrupt ZOLADEX until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed, or for other grade 4 skin reactions, permanently discontinue ZOLADEX.

Cervical Resistance: ZOLADEX may cause an increase in cervical resistance. Therefore, caution is recommended when dilating the cervix for endometrial ablation.

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits.

Injection Site Injury: 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.

Depression: Depression may occur or worsen in women receiving GnRH agonists, including ZOLADEX. Monitor and manage appropriately. Carefully observe women for depression, especially those with a history and consider if risks outweigh the 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.

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.

Please see Full Prescribing Information for ZOLADEX 3.6 mg and ZOLADEX 10.8 mg.

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, including pain relief and reduction of endometriotic lesions for the duration of therapy
  • 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