1. Menstruation should stop with effective doses of ZOLADEX. The patient should notify her physician if regular menstruation persists. Patients missing one or more successive doses of ZOLADEX may experience breakthrough menstrual bleeding [see Warnings and Precautions (5.1)].
  2. ZOLADEX should not be used in a pregnant or breastfeeding woman except for the palliative treatment of advanced breast cancer. ZOLADEX may harm the fetus and increase the risk for pregnancy loss [see Contraindications (4.2), Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
  3. A woman should not begin ZOLADEX treatment if she has undiagnosed abnormal vaginal bleeding, or is allergic to any of the components of ZOLADEX [see Clinical Studies (14.3)].
  4. Premenopausal women using ZOLADEX must use nonhormonal contraception during treatment and for 12 weeks after treatment ends [see Warnings and Precautions (5.1)].
  5. If a patient becomes pregnant while using ZOLADEX for endometriosis or endometrial thinning, ZOLADEX treatment should be discontinued. The patient should be advised of the possible risks to the pregnancy and fetus, including an increased risk of pregnancy loss [see Contraindications (4.2) and Use in Specific Populations (8.1)].
  6. Those adverse events occurring most frequently in clinical studies with ZOLADEX are associated with hypoestrogenism; of these, the most frequently reported are hot flashes (flushes), headaches, vaginal dryness, emotional lability, change in libido, depression, sweating and change in breast size. Clinical studies in endometriosis suggest the addition of Hormone Replacement Therapy (estrogens and/or progestins) to ZOLADEX may decrease the occurrence of vasomotor symptoms and vaginal dryness associated with hypoestrogenism without compromising the efficacy of ZOLADEX in relieving pelvic symptoms. The optimal drugs, dose and duration of treatment has not been established [see Dosage and Administration (2.3) and Adverse Reactions (6.5) and (6.7)].
  7. The use of GnRH agonists in women may cause a reduction in bone mineral density. In women, current available data suggest that recovery of bone loss occurs on cessation of therapy in the majority of patients.  
In patients with a history of prior treatment that may have resulted in bone mineral density loss and/or in patients with major risk factors for decreased bone mineral density such as chronic alcohol abuse and/or tobacco abuse, significant family history of osteoporosis, or chronic use of drugs that can reduce bone density such as anticonvulsants or corticosteroids, ZOLADEX therapy may pose an additional risk. In these patients the risks and benefits must be weighed carefully before therapy with ZOLADEX is instituted [see Adverse Reactions (6.8) and (6.10)].
  8. Currently, there are no clinical data on the effects of retreatment or treatment of benign gynecological conditions with ZOLADEX for periods in excess of 6 months [see Dosage and Administration (2.3)].
  9. As with other hormonal interventions that disrupt the pituitary-gonadal axis, some patients may have delayed return to menses. The rare patient, however, may experience persistent amenorrhea [see Drug Interactions (7.1) and Clinical Studies (14.3) and (14.4)].
  10. Injection site injury has been reported following injection of ZOLADEX. Inform patients to contact their doctor immediately if they experience any of the following symptoms: abdominal pain, abdominal distension, dyspnea, dizziness, hypotension and/or any altered levels of consciousness [see Warnings and Precautions (5.9)].



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Rev. 02/2020