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These brands contain the same active ingredient (Obeticholic Acid). Same strength and form. Confirm the switch with your doctor or pharmacist.
More from Obeliva
Other strengths and forms by Everest Pharmaceuticals Ltd.
Indications & Uses
Obeliva is indicated for:
Pharmacology
Mechanism of Action: Obeticholic acid is an agonist of the Farnesoid X Receptor (FXR), a nuclear receptor found in the liver and intestine. FXR is a main regulator of bile acid, inflammatory, fibrotic and metabolic pathways. When FXR is activated, the concentration of bile acids inside the hepatocytes falls. This happens in two ways: de novo synthesis of bile acids from cholesterol is suppressed, and more bile acids are transported out of the hepatocytes. Together these actions limit the size of the circulating bile acid pool and promote choleresis, so the liver is exposed to less bile acid.
Pharmacodynamics: Pharmacodynamic Markers: In the trial, obeticholic acid 10 mg once daily was linked with a 173% increase in FGF-19 concentrations from baseline to Month 12. FGF-19 is an FXR-inducible enterokine involved in bile acid homeostasis. Over the same period, cholic acid fell by 2.7 micromolar and chenodeoxycholic acid by 1.4 micromolar. The clinical relevance of these findings is unknown.
Cardiac Electrophysiology: At 10 times the maximum recommended dose, obeticholic acid does not prolong the QT interval to any clinically relevant extent.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Important dosage and administration instructions come first. Before starting Obeticholic acid, the doctor should find out whether the patient has decompensated cirrhosis (for example Child-Pugh Class B or C), has had a prior decompensation event, or has compensated cirrhosis with evidence of portal hypertension (for example ascites, gastroesophageal varices, persistent thrombocytopenia). Obeticholic acid is contraindicated in these patients.
The recommended dosage regimen is for PBC patients without cirrhosis, or with compensated cirrhosis who have no evidence of portal hypertension. These patients have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year, or they are intolerant to UDCA. Start with 5 mg once daily for the first 3 months. After the first 3 months, if the patient has not achieved an adequate reduction in ALP and/or total bilirubin and is tolerating Obeticholic acid, increase to a maximum dosage of 10 mg once daily.
Monitoring is how you assess safety and the need for Obeticholic acid discontinuation. Routinely monitor patients during treatment for biochemical response, tolerability and progression of PBC. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (for example autoimmune hepatitis, alcoholic liver disease) and/or severe intercurrent illness. Look for new evidence of portal hypertension (for example ascites, gastroesophageal varices, persistent thrombocytopenia) or increases above the upper limit of normal in total bilirubin, direct bilirubin or prothrombin time. Permanently discontinue Obeticholic acid 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.
For the management of intolerable pruritus on Obeticholic acid, consider one or more of these strategies. Add an antihistamine or bile acid-binding resin. Reduce the dosage to 5 mg every other day for patients intolerant to 5 mg once daily, or to 5 mg once daily for patients intolerant to 10 mg once daily. Another option is to temporarily interrupt dosing for up to 2 weeks and then restart at a reduced dosage. When the dosage has been reduced or interrupted, titrate it based on biochemical response and tolerability. If a patient still has persistent, intolerable pruritus despite these strategies, consider discontinuing Obeticholic acid.
Side Effects
The most common side effects of Obeticholic Acid are pruritus (itching), fatigue, and stomach pain and discomfort. Other side effects that people often report are rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness and constipation. Abnormal thyroid function and eczema (inflammation of the skin) are also seen.
Cautions & Contraindications
Warnings & Precautions
Hepatic Decompensation and Failure in PBC Patients with Cirrhosis Hepatic decompensation and failure have been reported in PBC patients with cirrhosis, either compensated or decompensated, who were treated with Obeticholic Acid. Some of these cases were fatal or ended in a liver transplant. Among the postmarketing cases that reported it, the median time to hepatic decompensation (for example, new onset ascites) was 4 months in patients with compensated cirrhosis. The median time to a new decompensation event (for example, hepatic encephalopathy) was 2.5 months in patients with decompensated cirrhosis. Some cases in patients with decompensated cirrhosis happened when they were given a higher dosage than the one recommended for that group. But cases of hepatic decompensation and failure have still been reported in patients with decompensated cirrhosis who received the recommended dosage. Hepatotoxicity was seen in the Obeticholic Acid clinical trials. In two 3-month, placebo-controlled trials in patients with primarily early stage PBC, a dose-response relationship was seen for hepatic adverse reactions, including jaundice, worsening ascites and primary biliary cholangitis flare. The dosages ranged from 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), and the reactions appeared as early as one month after starting treatment. A pooled analysis of three placebo-controlled trials, again in patients with primarily early-stage PBC, looked at all serious and otherwise clinically significant hepatic adverse reactions and isolated elevations in liver biochemical tests. The exposure-adjusted incidence rates per 100 patient exposure years (PEY) were 5.2 in the 10 mg group (the highest recommended dosage), 19.8 in the 25 mg group (2.5-times the highest recommended dosage) and 54.5 in the 50 mg group (5-times the highest recommended dosage). In the placebo group the rate was 2.4. Severe Pruritus In Trial 1, a 12-month double-blind randomized controlled clinical trial of 216 patients, severe pruritus was reported in 23% of patients in the Obeticholic Acid 10 mg arm, 19% in the titration arm and 7% in the placebo arm. Severe pruritus was defined as intense or widespread itching that interfered with activities of daily living, or caused severe sleep disturbance or intolerable discomfort, and typically needed medical intervention. Some patients in the titration arm raised their dosage from 5 mg once daily to 10 mg once daily after 6 months of treatment (n=33). In this subgroup the incidence of severe pruritus was 0% from months 0 to 6 and 15% from months 6 to 12. The median time to onset of severe pruritus was 11 days in the Obeticholic Acid 10 mg arm, 158 days in the titration arm and 75 days in the placebo arm. Consider clinical evaluation of patients with new onset or worsening severe pruritus. Management strategies include adding bile acid binding resins or antihistamines, reducing the Obeticholic Acid dosage, and/or temporarily interrupting dosing. Reduction in HDL-C Patients with PBC generally have hyperlipidemia, with a significant rise in total cholesterol mainly due to increased levels of high-density lipoprotein-cholesterol (HDL-C). In the trial, dose-dependent reductions from baseline in mean HDL-C levels were seen at 2 weeks in patients treated with Obeticholic Acid. These were 20% in the 10 mg arm and 9% in the titration arm, compared to 2% in the placebo arm. At Month 12, the reduction from baseline in mean HDL-C was 19% in the 10 mg arm, 12% in the titration arm and 2% in the placebo arm. HDL-C fell to less than 40 mg/dL in 9 patients in the 10 mg arm and 6 patients in the titration arm, versus 3 patients in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. If a patient has not responded to Obeticholic Acid after 1 year at the highest recommended dosage they can tolerate (maximum of 10 mg once daily) and also has a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment.
Contraindications
Obeticholic acid must not be given to patients with decompensated cirrhosis (for example Child-Pugh Class B or C) or to those who have had a decompensation event before. It is also contraindicated in patients with compensated cirrhosis who show signs of portal hypertension (for example ascites, gastroesophageal varices or persistent thrombocytopenia). The third contraindication is complete biliary obstruction.
Pregnancy & Breastfeeding
Pregnancy: There isn't enough human data on obeticholic acid in pregnancy to say whether it carries a risk to the baby. In animal reproduction studies, pregnant rats and rabbits were given obeticholic acid during organogenesis, at exposures of about 13-times and 6-times the human exposure at the maximum recommended human dose (MRHD) of 10 mg. No developmental abnormalities or fetal harm were seen.
Lactation: Nothing is known about whether obeticholic acid passes into human milk, what it does to a breastfed infant, or how it affects milk production. A doctor should weigh the developmental and health benefits of breastfeeding against the mother's clinical need for obeticholic acid. They should also consider any possible adverse effects on the breastfed infant, whether from obeticholic acid or from the mother's underlying condition.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use
The safety and effectiveness of Obeticholic Acid in pediatric patients have not been established.
Geriatric Use
In the clinical trials, 201 patients received the recommended dose of Obeticholic Acid (5 mg or 10 mg once daily). Of these, 41 (20%) were 65 years of age and older, and 9 (4%) were 75 years of age and older. The researchers saw no overall differences in safety or effectiveness between these patients and those under 65. Still, some older people may be more sensitive to the medicine, and this cannot be ruled out.
Hepatic Impairment
Hepatic decompensation and failure have been reported in PBC patients with cirrhosis (compensated or decompensated) treated with Obeticholic Acid. Some of these cases were fatal or ended in a liver transplant. Obeticholic Acid is contraindicated in patients with decompensated cirrhosis (e.g., Child-Pugh Class B or C), in those with a prior decompensation event, and in those with compensated cirrhosis who have evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). In the PBC clinical trials, the occurrence of hepatic adverse reactions showed a dose-response relationship with Obeticholic Acid.
Overdose
In clinical trials, people with PBC who took Obeticholic Acid 25mg once daily (2.5 times the highest recommended dosage) or 50mg once daily (5 times the highest recommended dosage) had more hepatic adverse reactions as the dose went up. These included raised liver biochemical tests, ascites, jaundice, portal hypertension and primary biliary cholangitis flares.
After the medicine came on the market, serious hepatic adverse reactions were reported in PBC patients with decompensated cirrhosis when Obeticholic Acid was taken more often than the recommended dosage. Some patients who took the recommended dosage had these reactions too. If an overdose happens, patients should be watched carefully and given supportive care as appropriate.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Obeticholic Acid below 30°C in a dry place and away from light. Make sure children can't reach it.
Drug Interactions
Common questions about Obeliva 5 mg
What is Obeliva 5 mg Tablet?
Obeliva 5 mg Tablet is a medicine that contains Obeticholic Acid. It is made by Everest Pharmaceuticals Ltd. It belongs to the Farnesoid X Receptor Agonists group of medicines.
What is Obeliva used for?
Obeliva is used for: Hypertension.
What are the side effects of Obeliva?
The most common side effects of Obeticholic Acid are pruritus (itching), fatigue, and stomach pain and discomfort. Other side effects that people often report are rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness and constipation.
Can I take Obeliva during pregnancy or while breastfeeding?
Pregnancy: There isn't enough human data on obeticholic acid in pregnancy to say whether it carries a risk to the baby. In animal reproduction studies, pregnant rats and rabbits were given obeticholic acid during organogenesis, at exposures of about 13-times and 6-times the human exposure at the maximum recommended human dose (MRHD) of 10 mg. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Obeliva?
In clinical trials, people with PBC who took Obeticholic Acid 25mg once daily (2.5 times the highest recommended dosage) or 50mg once daily (5 times the highest recommended dosage) had more hepatic adverse reactions as the dose went up. These included raised liver biochemical tests, ascites, jaundice, portal hypertension and primary biliary cholangitis flares. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Obeliva?
Keep Obeticholic Acid below 30°C in a dry place and away from light. Make sure children can't reach it.
Can I take other medicines with Obeliva?
Some medicines can interact with Obeticholic Acid, for example: Cyclosporine, Theophylline, Cholestyramine, Tizanidine, Warfarin Sodium, Colesevelam Hydrochloride. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Olic by The ACME Laboratories Ltd. has the same ingredient and strength for ৳27.00 per unit, compared with ৳30.00 for Obeliva. Ask your doctor or pharmacist before switching.
Do I need a prescription for Obeliva?
Obeliva is a prescription (Rx) medicine. Take it as your doctor advises.