When choosing a GnRH agonist for pre- and perimenopausal women with advanced breast cancer,

There’s ONLY 1 ZOLADEX

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Curved Edge Curved Edge

1 and only GnRH agonist with FDA approval for pre- and perimenopausal women with advanced breast cancer and survival data to support its indication1‑4

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#1 PRESCRIBED GnRH AGONIST

in the US for premenopausal women with advanced breast cancer5*

*Symphony Health, an ICON plc Company, PatientSource®, January 1, 2024 through June 30, 2025.

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#1 STUDIED GnRH AGONIST5†

and ONLY 1 studied with all three CDK4/6 inhibitors in their phase 3 pivotal trials6-8

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1+ MILLION DOSES

administered in breast cancer5‡

From TerSera launch of ZOLADEX in January 2017 through June 2025.

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ONLY GnRH AGONIST WITH A FULL SUITE OF PATIENT SUPPORT SERVICES

for women with advanced breast cancer once ZOLADEX is prescribed

GnRH=gonadotropin-releasing hormone.

According to ClinicalTrials.gov, 139 studies have been registered that included 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 52 studies with leuprolide or leuprolide acetate (first posted data in 2003) and 30 studies with triptorelin or triptorelin pamoate (first posted data in 2003).

Additional ZOLADEX indications include:

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Treatment of advanced prostate cancer

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Management of endometriosis

  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.

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.

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.

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.

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 accompanying 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
  • 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.

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.

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.

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 accompanying 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
  • 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