Buy Ocaliva 10 mg online, Buy Obeticholic Acid 10 mg online.
Obeliva (Obeticholic Acid) 10 mg by Everest is the only choice for Primary Biliary Cirrhosis (PBC) with the combination of UDCA (Ursodeoxycholic Acid).
Obeliva is the alternative & generic version of Ocaliva by Intercept Pharmaceuticals, Inc. Obeliva is manufactured by Everest Pharmaceuticals Bangladesh which is the biggest pharmaceutical company in Bangladesh.
Therapeutic Class
Farnesoid X Receptor Agonists
Pharmacology
Obeticholic Acid is an agonist for 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.
Dosage & Administration
Starting Dosage: The recommended starting dosage of Obeticholic Acid is 5 mg orally once daily in adult patients who have not achieved an adequate biochemical response to an appropriate dosage of Ursodeoxycholic Acid (UDCA) for at least 1 year or are intolerant to UDCA.
Dosage Titration: If an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin has not been achieved after 3 months of Obeticholic Acid 5 mg once daily, and the patient is tolerating Obeticholic Acid.
Maximum Dosage: The maximum recommended dosage of Obeticholic Acid is 10 mg once daily.
Management of Patients with Intolerable Pruritus on Obeticholic Acid: For patients with intolerable pruritus on Obeticholic Acid, consider one or more of the following:
Add an antihistamine or bile acid binding resin. Reduce the dosage of Obeticholic Acid to:
Temporarily interrupt Ocaliva / Obeticholic Acid dosing for up to 2 weeks followed by restarting at a reduced dosage
Increase the dosage of Obeticholic Acid to 10 mg once daily, as tolerated, to achieve optimal response. Consider discontinuing Obeticholic Acid treatment in patients who continue to experience persistent, intolerable pruritus.
Interaction
Bile Acid Binding Resins: 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 Ocaliva / Obeticholic Acid at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible.
Warfarin: The International Normalized Ratio (INR) decreased following co-administration of warfarin and Obeticholic Acid. Monitor INR and adjust the dosage of warfarin, as needed, to maintain the target INR range when co-administering Obeticholic Acid and warfarin.
CYP1A2 Substrates with Narrow Therapeutic Index: Ocaliva / Obeticholic Acid may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index.
Contraindications
Contraindicated in patients known to have hypersensitivity to the drug or any of its components & in patients with complete biliary obstruction.
Side Effects
The most common side effects of Ocaliva / Obeticholic Acid include: Pruritus, Fatigue & Stomach pain and discomfort. Other common side effects include rash, arthralgia (joint pain), oropharyngeal pain (pain in the middle part of the throat), dizziness, constipation, abnormal thyroid function.
Pregnancy & Lactation
The limited available human data on the use of Obeticholic Acid during pregnancy are not sufficient to inform a drug-associated risk.
There is no information on the presence of Ocaliva / Obeticholic Acid in human milk, the effects on the breast-fed infant or the effects on milk production.
Precautions & Warnings
The following clinically significant reactions are described:
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Liver-Related Adverse Reactions
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Severe Pruritus
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Reduction in high density lipoprotein-cholesterol (HDL-C)