Patients should be started at the lowest approved dose of 0.3 mg ENJUVIA daily. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider.
The most common side effects in the clinical trials were headache, pain, nausea, and breast pain. In clinical trials, adverse events that occurred at a rate greater than or equal to 5% and greater than placebo, regardless of relationship to study drug, included: abdominal pain, accidental injury, breast pain, bronchitis, dizziness, dysmenorrhea, flatulence, flu syndrome, headache, nausea, pain, paresthesia, rhinitis, sinusitis, and vaginitis.
ENJUVIA tablets should not be used in individuals with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active or recent (e.g. within the past year) arterial thromboembolic disease (e.g. stroke, myocardial infarction); liver dysfunction or disease; hypersensitivity to its ingredients; or known or suspected pregnancy. There is no indication for ENJUVIA in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.
|SOURCE Barr Pharmaceuticals, Inc.|
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