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.