Close-up of two women's hands clasped together

When choosing ovarian suppression, ZOLADEX^® is the ONLY GnRH agonist:

	with FDA approval for premenopausal women with advanced breast cancer¹
	that has survival data to support its indication in breast cancer^1-4
	studied with all three CDK4/6 inhibitors in their phase 3 pivotal trials^5-7
	with a full suite of patient support services for women with advanced breast cancer once ZOLADEX is prescribed

CDK4/6 = cyclin-dependent kinase 4 and 6; GnRH = gonadotropin-releasing hormone; HR+ = hormone receptor-positive.

Select Safety Information

Anaphylactic reactions to ZOLADEX have been reported in the medical literature. ZOLADEX is contraindicated in patients with a known hypersensitivity to GnRH, GnRH agonist analogues, or any of the components in ZOLADEX.

Looking for more information about ZOLADEX?

For more information, visit ZOLADEXhcp.com

Important Safety Information (Cont)

ZOLADEX is contraindicated during pregnancy unless used for palliative treatment of advanced breast cancer. ZOLADEX can cause fetal harm when administered to a pregnant woman. If used during pregnancy, the patient should be apprised of the potential hazard to the fetus. There is an increased risk for pregnancy loss due to expected hormonal changes that occur with ZOLADEX treatment. ZOLADEX should not be given to women with undiagnosed abnormal vaginal bleeding.

Pregnancy must be excluded for use in benign gynecological conditions. Women should be advised against becoming pregnant while taking ZOLADEX. Effective nonhormonal contraception must be used by all premenopausal women during ZOLADEX therapy and for 12 weeks following discontinuation of therapy.

Transient worsening of tumor symptoms, or the occurrence of additional signs and symptoms of breast cancer, may occasionally develop during the first few weeks of treatment. Some patients may experience a temporary increase in bone pain. Monitor patients at risk for complications of tumor flare.

Hyperglycemia and an increased risk of developing diabetes or worsening of glycemic control in patients with diabetes have been reported in men receiving GnRH agonists like ZOLADEX. Monitor blood glucose levels and glycosylated hemoglobin (HbA1c) periodically and manage according to current clinical practice.

Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists like ZOLADEX in men. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.

Hypercalcemia has been reported in some breast cancer patients with bone metastases after starting treatment with ZOLADEX. If hypercalcemia does occur, appropriate treatment measures should be initiated.

Hypersensitivity, antibody formation and acute anaphylactic reactions have been reported with GnRH agonist analogues.

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

GnRH agonists may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Injection site injury and vascular injury including pain, hematoma, hemorrhage and hemorrhagic shock, requiring blood transfusions and surgical intervention, 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 may occur or worsen in women receiving GnRH agonists.

Treatment with ZOLADEX may be associated with a reduction in bone mineral density over the course of treatment. Data suggest a possibility of partial reversibility. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients.

In women, the most frequently reported adverse reactions were related to hypoestrogenism. The adverse reaction profile was similar for women treated for breast cancer, dysfunctional uterine bleeding, and endometriosis.

The most commonly reported adverse reactions with ZOLADEX in breast cancer clinical trials were hot flashes (70%), decreased libido (47.7%), tumor flare (23%), nausea (11%), edema (5%), and malaise/fatigue/lethargy (5%). Injection site reactions were reported in less than 1% of patients.

Indication

Palliative treatment of advanced breast cancer in pre- and perimenopausal women.

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 cost information for Colorado prescribers, please click here.

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. Im SA, Lu YS, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381:307-316. 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. VERZENIO^® (abemaciclib). Prescribing Information. Eli Lilly and Company.

ZOLADEX is a registered trademark of AstraZeneca or its affiliates and is used herein under license.
TERSERA and the TERSERA LOGO are registered trademarks of TerSera Therapeutics LLC.
©2024 TerSera Therapeutics LLC. All rights reserved.
ZOL-P-1188 (09‍/‍2024)

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