Bilovia^®

BILOVIA  is a preparation of Obeticholic Acid which is an agonist for famesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. FXR activation decreases the intracellular hepatocyte concentrations of bile acids by suppressing de novo synthesis from cholesterol as well as by increased transport of bile acids out of the hepatocytes. These mechanisms limit the overall size of the circulating bile acid pool while promoting choleresis, thus reducing hepatic exposure to bile acids.

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BILOVIA 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.

Route of administration:

BILOVIA should be taken orally with or without food. Start BILOVIA ® 5 once daily for the first three months. After the first three months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating obeticholic acid increase to a maximum dosage of BILOVIA ® 10 once daily.
For patients with intolerable pruritus on BILOVIA dosage can be reduced to:

• 5 mg every other day, for patients intolerant to 5 mg once daily.
• 5 mg once daily, for patients intolerant to 10 mg once daily.
• Temporarily interrupt BILOVIA ® dosing for up to two weeks. Restart at a reduced dosage.

For patients whose dosage is reduced or interrupted, titrate the dosage based on biochemical response and tolerability. Consider discontinuing BILOVIA® treatment in patients who continue to experience persistent, intolerable pruritus despite dose adjustment.

Pregnancy: There are no adequate and well-controlled studies on use of obeticholic acid in pregnant women. 

Lactation: There is no information on the presence of obeticholic acid in human milk, the effects on the breast-fed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for obeticholic acid and any potential adverse effects on the breastfed infant from obeticholic acid or from the underlying maternal condttion.

Use in children and adolescents
Safety and effectiveness of obeticholic acid in pediatric patients have not been established.

Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with obeticholic acid treatment in PBC patients with cirrhosis, either compensated or decompensated. Routinely monitor patients for progression of PBC including hepatic adverse reactions and with laboratory and clinical assessments, determine whether drug discontinuation is needed. Permanently discontinue 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. Obeticholic acid can cause severe pruritus and reduction in HDL-C . Routine monitoring, proper clinical evaluation and dosage reduction and/or temporary dosing interruption should be considered.

The most common side effects are pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality and eczema.

It is contraindicated in patients with history of known hypersensitivity to obeticholic acid or any other components of this product. It is also contraindicated in patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event, compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia) and complete biliary obstruction.

Drug interaction with medication: 

Concomitant use with bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure and efficacy of obeticholic acid. If taking a bile acid binding resin, take obeticholic acid at least four hours before or four hours after taking the bile acid binding resin or at as great an interval as possible. The International Normalized Ratio (INR) decreases following coadministration of warfarin and obeticholic acid. Monitor INR and adjust the dosage of warfarin as needed. Obelicholic acid may increase the exposure to concomitant drugs that are CYP1A2. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline and tizanidine) is recommended when co-administered with obeticholic acid. Concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine should be avoided. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin.

Drug interaction with food and others:

Not applicable.

In the case of overdosage, patients should be carefully observed and supportive care administered as appropriate.

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BILOVIA  5 tablet: Each coated tablet contains Obeticholic Acid INN 5 mg.
B1LOVIA 10 tablet: Each coated tablet contains Obeticholic Acid INN 10 mg.

BILOVIA 5: Carton of 10 tablets in blister pack.

BILOVIA 10: Carton of 10 tablets in blister pack.