{"id":637,"date":"2026-04-12T17:27:44","date_gmt":"2026-04-12T17:27:44","guid":{"rendered":"https:\/\/luciuspharmacy.com\/?post_type=product&p=637"},"modified":"2026-08-30T03:53:25","modified_gmt":"2026-08-30T03:53:25","slug":"lucielafib-elafibranor-80-mgx30-tablets","status":"publish","type":"product","link":"https:\/\/luciuspharmacy.com\/es\/product\/lucielafib-elafibranor-80-mgx30-tablets\/","title":{"rendered":"LuciElafib"},"content":{"rendered":"

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

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

 <\/span><\/p>\n

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

LuciElafib is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. <\/span><\/p>\n

 <\/span><\/p>\n

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).<\/span><\/p>\n

 <\/span><\/p>\n

Limitations of Use:<\/span><\/p>\n

Use of LuciElafib is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). <\/span><\/p>\n

 <\/span><\/p>\n

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

\u2022 Before treatment, evaluate for muscle pain or myopathy, and\/or verify that females of reproductive potential are not pregnant. <\/span><\/p>\n

\u2022 The recommended dosage is 80 mg orally once daily with or without Food.<\/span><\/p>\n

 <\/span><\/p>\n

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

Tablets: 80 mg\u00d730 tablets<\/span><\/p>\n

 <\/span><\/p>\n

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

None<\/span><\/p>\n

 <\/span><\/p>\n

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

\u2022 Myalgia, Myopathy, and Rhabdomyolysis: Assess for muscle pain and myopathy prior to LuciElafib initiation. Consider periodic assessment (clinical exam, CPK measurement). Interrupt LuciElafib if there is new onset or worsening of muscle injury, or muscle pain. <\/span><\/p>\n

\u2022 Fractures: The risk of fracture should be considered in the care of patients treated with LuciElafib. Apply current standards of care for assessing and maintaining bone health. <\/span><\/p>\n

\u2022 Adverse Effects on Fetal and Newborn Development: May cause fetal harm. Verify that a female of reproductive potential is not pregnant prior to initiating LuciElafib. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. <\/span><\/p>\n

\u2022 Drug-Induced Liver Injury: Obtain clinical and laboratory assessments at treatment initiation and monitor thereafter according to routine patient management. Interrupt the treatment if liver tests worsen, or patients develop signs and symptoms consistent with clinical hepatitis. Consider permanent discontinuation if liver tests worsen after restarting LuciElafib. <\/span><\/p>\n

\u2022 Hypersensitivity Reactions: If severe hypersensitivity reactions occur, permanently discontinue LuciElafib. If a mild or moderate hypersensitivity reaction occurs, interrupt LuciElafib and treat promptly. Monitor until signs and symptoms resolve. <\/span><\/p>\n

\u2022 Biliary Obstruction: Avoid use in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt LuciElafib and treat as clinically indicated.<\/span><\/p>\n

 <\/span><\/p>\n

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

Most common adverse reactions with LuciElafib (reported in \u2265 5% and higher compared to placebo) are weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash. <\/span><\/p>\n

 <\/span><\/p>\n

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

\u2022 Hormonal Contraceptives: Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after last dose.<\/span><\/p>\n

\u2022 HMG-CoA Reductase Inhibitors: Monitor for signs and symptoms of muscle injury.<\/span><\/p>\n

\u2022 Rifampin:Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during LuciElafib treatment.<\/span><\/p>\n

\u2022 Bile Acid Sequestrants: Administer at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible.<\/span><\/p>\n

 <\/span><\/p>\n

USE IN SPECIFIC POPULATIONS <\/strong><\/strong><\/span><\/p>\n

\u2022 Lactation: Advise not to breastfeed during treatment and for 3 weeks after last dose. <\/span><\/p>\n

\u2022 Hepatic Impairment: Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuation if patient progresses to moderate or severe hepatic impairment (Child-Pugh B or C).<\/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":"

LuciElafib is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. <\/p>","protected":false},"featured_media":2133,"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-637","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\/es\/wp-json\/wp\/v2\/product\/637","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/types\/product"}],"replies":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/comments?post=637"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/media\/2133"}],"wp:attachment":[{"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/media?parent=637"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product_brand?post=637"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product_cat?post=637"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/luciuspharmacy.com\/es\/wp-json\/wp\/v2\/product_tag?post=637"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}