tially 5mg once weekly; increase to 5mg twice weekly (≥3 days apart) then to 10mg twice weekly (≥3 days apart) ifinadequate reduction in ALP and/or total bilirubin after 3 months and tolerated the drug. Intolerable pruritus: consider adding an antihistamine or bile acid bindingresin; or reducing dose to 5mg every other day (if intolerant to 5mg daily) or 5mg once daily (if intolerant to 10mg daily); or temporarily interrupt for up to 2 weeksthen restart at lower dose. Increase dose to 10mg once daily as tolerated for optimal response.
Children:
Not established.
Contraindications:
Complete biliary obstruction.
Warnings/Precautions:
Discontinue if intolerable pruritus persists or complete biliary obstruction develops. Monitor for elevations in liver biochemical tests and liver-related adverseeffects. Monitor for changes in serum lipid levels. If unresponsive after 1 year of treatment at max tolerable dose (10mg once daily) and experienced HDL-C reduction,reeva luate. Pregnancy. Nursing mothers.
Interactions:
Separate dosing by ≥4hrs or at greatest possible interval with bile acid binding resins (eg, cholestyramine, colestipol, colesevelam). Concomitant warfarin: monitorINR and adjust dose as needed. Concomitant CYP1A2 substrates with narrow therapeutic index (eg, theophylline, tizanidine); monitor.
Pharmacological Class:
Farnesoid X receptor (FXR) agonist.
Adverse Reactions:
Pruritus, fatigue, abdominal pain/discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, eczema; liver-relatedeffects, HDL-C reduction.
Generic Availability:
NO
How Supplied:
Tabs—30
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cdfbe0cd-eb15-45a1-ac17-531bcda21aec
--------------------------------------------------
产地国家： 美国
原产地英文商品名:
Ocaliva tabs 5mg/tablet 30tablets/bottle
原产地英文药品名:
obeticholic acid
中文参考商品译名:
Ocaliva片 5毫克/片 30片/瓶
中文参考药品译名:
奥贝胆酸
生产厂家中文参考译名:
Intercept Pharmaceuticals, Inc
生产厂家英文名:
Intercept Pharmaceuticals, Inc
--------------------------------------------------
产地国家： 美国
原产地英文商品名:
Ocaliva tabs 10mg/tablet 30tablets/bottle
原产地英文药品名:
obeticholic acid
中文参考商品译名:
Ocaliva片 10毫克/片 30片/瓶
中文参考药品译名:
奥贝胆酸
生产厂家中文参考译名:
Intercept Pharmaceuticals, Inc
生产厂家英文名:
Intercept Pharmaceuticals, Inc
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