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The use of ZOLADEX in patients at particular risk of developing ureteral obstruction or spinal cord compression should be considered carefully and the patients monitored closely during the first month of therapy. Patients with ureteral obstruction or spinal cord compression should have appropriate treatment prior to initiation of ZOLADEX therapy [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
The use of GnRH agonists may cause a reduction in bone mineral density. In men, data suggest the use of a bisphosphonate in combination with a GnRH agonist may reduce bone mineral loss [see ADVERSE REACTIONS].
Patients should be informed that diabetes or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with GnRH agonists, including ZOLADEX. Therefore, consideration should be given to monitoring blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving ZOLADEX [see WARNINGS AND PRECAUTIONS] .
A small increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists 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 [see WARNINGS AND PRECAUTIONS].
- 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].
- 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, WARNINGS AND PRECAUTIONS and Use In Specific Populations].
- 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].
- Premenopausal women using ZOLADEX must use nonhormonal contraception during treatment and for 12 weeks after treatment ends [see WARNINGS AND PRECAUTIONS].
- 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 and Use In Specific Populations].
- 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 and ADVERSE REACTIONS].
- 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].
- 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].
- 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 and Clinical Studies].
Last reviewed on RxList: 10/17/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Zoladex 3.6 Information
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