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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.