Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
OBETICHOLIC ACID (UNII: 0462Z4S4OZ) (OBETICHOLIC ACID - UNII:0462Z4S4OZ)
Intercept Pharmaceuticals Inc
Obeticholic Acid
Obeticholic Acid 5 mg
ORAL
PRESCRIPTION DRUG
OCALIVA® is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) - without cirrhosis or - 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. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP) [see Clinical Studies (14)] . 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. OCALIVA is contraindicated in patients with: - decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event [see Warnings and Precautions (5.1)] . - compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) [see Warnings and
OCALIVA tablets are packaged in a 40 mL high density polyethylene bottle closed with a 33 mm polypropylene child resistant cap containing an induction seal. Each bottle contains 30 tablets. 5 mg Tablets OCALIVA tablets are available as off-white to yellow, round tablets debossed with INT on one side and 5 on the other side. Each tablet contains 5 mg of obeticholic acid. 10 mg Tablets OCALIVA tablets are available as off-white to yellow, triangular tablets debossed with INT on one side and 10 on the other side. Each tablet contains 10 mg of obeticholic acid. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
New Drug Application
Intercept Pharmaceuticals Inc ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: April 2022 MEDICATION GUIDE OCALIVA® (o-CAL-eh-vah) (obeticholic acid) tablets What is the most important information I should know about OCALIVA? • Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA. OCALIVA can cause serious side effects including: Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA. • Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA: • swelling of your stomach-area from a build-up of fluid • yellowing of your skin or the whites of your eyes • black, tarry, or bloody stools • coughing up or vomiting blood, or your vomit looks like "coffee grounds" • mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality • Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away: • stomach-area pain • nausea, vomiting, or diarrhea • loss of appetite or weight loss • new or worsening fatigue • weakness • fever and chills • light-headedness • less frequent urination What is OCALIVA? OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone in adults who cannot tolerate UDCA. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. It is not known if OCALI Lestu allt skjalið
OCALIVA- OBETICHOLIC ACID TABLET, FILM COATED INTERCEPT PHARMACEUTICALS INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OCALIVA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCALIVA. OCALIVA (OBETICHOLIC ACID) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2016 WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ HEPATIC DECOMPENSATION AND FAILURE, SOMETIMES FATAL OR RESULTING IN LIVER TRANSPLANT, HAVE BEEN REPORTED WITH OCALIVA TREATMENT IN PRIMARY BILIARY CHOLANGITIS (PBC) PATIENTS WITH EITHER COMPENSATED OR DECOMPENSATED CIRRHOSIS. (5.1) OCALIVA IS CONTRAINDICATED IN PBC PATIENTS WITH DECOMPENSATED CIRRHOSIS, A PRIOR DECOMPENSATION EVENT, OR WITH COMPENSATED CIRRHOSIS WHO HAVE EVIDENCE OF PORTAL HYPERTENSION. (4) PERMANENTLY DISCONTINUE OCALIVA IN PATIENTS WHO DEVELOP LABORATORY OR CLINICAL EVIDENCE OF HEPATIC DECOMPENSATION, HAVE COMPENSATED CIRRHOSIS AND DEVELOP EVIDENCE OF PORTAL HYPERTENSION, OR EXPERIENCE CLINICALLY SIGNIFICANT HEPATIC ADVERSE REACTIONS WHILE ON TREATMENT. (2.3, 5.1) INDICATIONS AND USAGE OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or 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. 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. (1) DOSAGE AND ADMINISTRATION Recommended Dosage Regimen The recommended starting dosage of OCALIVA, for PBC patients without Lestu allt skjalið