Obeticholic Acid Brand Name– OCALIVA
What is Obeticholic Acid
Obeticholic acid is a farnesoid X receptor (FXR) agonist for the treatment of primary biliary cirrhosis, as monotherapy in adults unable to tolerate ursodeoxycholic acid or in combination with ursodeoxycholic acid in adults with inadequate response to ursodeoxycholic acid.
Obeticholic acid contains a black box warning for hepatic decompensation and failure in incorrectly dosed primary biliary cholangitis (PBC) patients with Child-Pugh Class B or C or decompensated cirrhosis; healthcare professionals should adhere to the recommended dosing and monitoring in the current drug label.
Obeticholic acid was FDA-approved in May 2016.
Indications
- biliary cirrhosis
For the treatment of primary biliary cholangitis / primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA
Side Effects
- abdominal pain
- arthralgia
- ascites
- asthenia
- biliary obstruction
- cholangitis
- constipation
- decreased HDL cholesterol (HDL-C) concentration
- dizziness
- eczema vaccinatum
- elevated hepatic enzymes
- fatigue
- fever
- GI bleeding
- hepatic encephalopathy
- hypothyroidism
- jaundice
- maculopapular rash
- ocular pruritus
- palpitations
- peripheral edema
- pruritus
- pruritus ani
- rash
- syncope
- urticaria
Monitoring Parameters
- LFTs
- serum bilirubin (total and direct)
- serum cholesterol
Contraindications
- biliary obstruction
- breast-feeding
- dehydration
- gastroenteritis
- hepatic decompensation
- hepatic disease
- jaundice
- peritonitis
- pregnancy
Interactions
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Aliskiren; Valsartan
- Alosetron
- Alprazolam
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Valsartan
- Amoxicillin; Clarithromycin; Omeprazole
- Anagrelide
- Asenapine
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Omeprazole
- Bendamustine
- Bictegravir; Emtricitabine; Tenofovir Alafenamide
- Bupivacaine; Lidocaine
- Caffeine
- Caffeine; Ergotamine
- Cholestyramine
- Cinacalcet
- Clomipramine
- Clozapine
- Colesevelam
- Colestipol
- Cyclosporine
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Elagolix
- Elagolix; Estradiol; Norethindrone acetate
- Elbasvir; Grazoprevir
- Eluxadoline
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Emtricitabine; Rilpivirine; Tenofovir alafenamide
- Emtricitabine; Tenofovir alafenamide
- Ezetimibe; Simvastatin
- Fluoxetine; Olanzapine
- Flutamide
- Fluvoxamine
- Hydrochlorothiazide, HCTZ; Triamterene
- Hydrochlorothiazide, HCTZ; Valsartan
- Imipramine
- Lidocaine
- Lidocaine; Prilocaine
- Maraviroc
- Melatonin
- Mexiletine
- Nebivolol; Valsartan
- Niacin; Simvastatin
- Olanzapine
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Pimozide
- Pirfenidone
- Propafenone
- Ramelteon
- Rasagiline
- Revefenacin
- Rifaximin
- Roflumilast
- Ropinirole
- Ropivacaine
- Rosuvastatin
- Sacubitril; Valsartan
- Simeprevir
- Simvastatin
- Simvastatin; Sitagliptin
- Sofosbuvir; Velpatasvir; Voxilaprevir
- Tasimelteon
- Tenofovir Alafenamide
- Tenofovir Alafenamide
- Theophylline, Aminophylline
- Thiabendazole
- Thiothixene
- Tizanidine
- Triamterene
- Valsartan
- Warfarin
- Zileuton
- Zolmitriptan
