Do not initiate if ALT or AST is ≥2x ULN or if total bilirubin is ≥2x ULN. Discontinue use if transaminase elevations are >5x ULN; >3x ULN & total bilirubin level is >2x ULN. Immediately discontinue & seek medical attention, including hepatic lab tests, if signs or symptoms of hepatotoxicity eg, new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale faeces, dark urine, or abdominal pain occur. Not recommended to be used in women undergoing oncologic treatment (eg, chemotherapy, RT, anti-hormone therapy) for breast cancer or other oestrogen-dependent malignancies. Not recommended to be used w/ HRT w/ oestrogens (local vag prep excluded). Elevations in serum ALT & AST at least 3x ULN. Known or history of breast cancer or other oestrogen-dependent malignancies; seizures or other convulsive disorders. Careful diagnosis & complete medical history (including family history) should be made prior to initiation or reinstitution of treatment. Evaluate hepatic function (ALT, AST, alkaline phosphatase, & bilirubin) before initiating therapy. Mthly follow-up evaluation of hepatic function is recommended for 1st 3 mth of initiating treatment & periodically thereafter. Periodic check-ups must be carried out according to standard clinical practice during treatment. Not recommended in patients w/ Child-Pugh Class B (moderate) or C (severe) chronic hepatic impairment; severe renal impairment (eGFR <30 mL/min/1.73 m
2); ESRD (eGFR <15 mL/min/1.73 m
2). Perimenopausal women of childbearing potential should use effective contraception. Immediately w/draw if pregnancy occurs. Lactation. Elderly >65 yr.
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