{"id":610,"date":"2026-04-12T15:39:23","date_gmt":"2026-04-12T15:39:23","guid":{"rendered":"https:\/\/luciuspharmacy.com\/?post_type=product&p=610"},"modified":"2026-08-30T03:53:25","modified_gmt":"2026-08-30T03:53:25","slug":"luciobe-obeticholic-acid-5-mgx30-tablets","status":"publish","type":"product","link":"https:\/\/luciuspharmacy.com\/ru\/product\/luciobe-obeticholic-acid-5-mgx30-tablets\/","title":{"rendered":"LuciObe"},"content":{"rendered":"

HIGHLIGHTS OF PRESCRIBING INFORMATION <\/strong><\/span><\/p>\n

These highlights do not include all the information needed to use LuciObe safely and effectively. See full prescribing information for LuciObe.<\/strong><\/span><\/p>\n

 <\/span><\/p>\n

INDICATIONS AND USAGE<\/strong><\/strong><\/span><\/p>\n

LuciObe, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) <\/span><\/p>\n

\u2022 without cirrhosis or  <\/span><\/p>\n

\u2022 with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.  <\/span><\/p>\n

This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. <\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE AND ADMINISTRATION <\/strong><\/strong><\/span><\/p>\n

Recommended Dosage Regimen <\/span><\/p>\n

The recommended starting dosage of LuciObe, for PBC patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year or who are intolerant to UDCA follows below: <\/span><\/p>\n

\u2022 Start with a dosage of 5 mg once daily for the first 3 months. <\/span><\/p>\n

\u2022 After the first 3 months, for patients who have not achieved an adequate reduction in ALP and\/or total bilirubin and who are tolerating LuciObe, increase to a maximum dosage of 10 mg once daily. <\/span><\/p>\n

Routinely monitor patients during LuciObe treatment for biochemical response, tolerability, and progression of PBC. <\/span><\/p>\n

Management of Patients with Intolerable Pruritus  <\/span><\/p>\n

\u2022 See full prescribing information for management options. <\/span><\/p>\n

Administration Instructions <\/span><\/p>\n

\u2022 Take with or without food. <\/span><\/p>\n

\u2022 For patients taking bile acid binding resins, take LuciObe at least 4 hours before or 4 hours after taking a bile acid binding resin, or at as great an interval as possible. <\/span><\/p>\n

 <\/span><\/p>\n

DOSAGE FORMS AND STRENGTHS <\/strong><\/strong><\/span><\/p>\n

Tablets: 5 mg\u00d730 tablets<\/span><\/p>\n

 <\/span><\/p>\n

CONTRAINDICATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event.<\/span><\/p>\n

\u2022 compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia).<\/span><\/p>\n

\u2022 complete biliary obstruction.<\/span><\/p>\n

 <\/span><\/p>\n

WARNINGS AND PRECAUTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Hepatic Decompensation and Failure in PBC Patients with Cirrhosis: Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments. Closely monitor patients at risk of hepatic decompensation. Permanently discontinue in patients who develop laboratory or clinical evidence of hepatic decompensation; have compensated cirrhosis and develop evidence of portal hypertension; experience clinically significant hepatic adverse reactions; or develop complete biliary obstruction. Interrupt treatment in patients with severe intercurrent illness.<\/span><\/p>\n

\u2022 Severe Pruritus: Management strategies include the addition of bile acid binding resins or antihistamines; LuciObe dosage reduction and\/or temporary dosing interruption.<\/span><\/p>\n

\u2022 Reduction in HDL-C: Monitor for changes in serum lipid levels during treatment. <\/span><\/p>\n

 <\/span><\/p>\n

ADVERSE REACTIONS <\/strong><\/strong><\/span><\/p>\n

Most common adverse reactions (\u2265 5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. <\/span><\/p>\n

 <\/span><\/p>\n

DRUG INTERACTIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Warfarin: Potential for decreased INR; monitor INR and adjust the dosage of warfarin, as needed, to maintain the target INR range. <\/span><\/p>\n

\u2022 CYP1A2 Substrates with Narrow Therapeutic Index (e.g., theophylline and tizanidine): Potential for increased exposure to CYP1A2 substrates; monitor drug concentrations of CYP1A2 substrates with narrow therapeutic index.<\/span><\/p>\n

\u2022 Inhibitors of Bile Salt Efflux Pump (e.g., cyclosporine): Avoid use. If concomitant use is necessary, monitor serum transaminases and bilirubin. <\/span><\/p>\n

 <\/span><\/p>\n

Storage <\/strong><\/strong><\/span><\/p>\n

Store at 20\u00b0C to 25\u00b0C (68\u00b0F to 77\u00b0F), excursions permitted between 15\u00b0C and 30\u00b0C (59\u00b0F and 86\u00b0F) [see USP Controlled Room Temperature]. Protect from moisture. <\/span><\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

LuciObe, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)<\/p>","protected":false},"featured_media":1826,"comment_status":"open","ping_status":"closed","template":"","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"jetpack_seo_schema_type":""},"product_brand":[],"product_cat":[48],"product_tag":[],"class_list":["post-610","product","type-product","status-publish","has-post-thumbnail","product_cat-other-medicines","first","instock","shipping-taxable","purchasable","product-type-simple"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product\/610","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/comments?post=610"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/media\/1826"}],"wp:attachment":[{"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/media?parent=610"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product_brand?post=610"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product_cat?post=610"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/ru\/wp-json\/wp\/v2\/product_tag?post=610"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}