Buy Obetix 5 MG (Obeticholic Acid) - Mediaid pharmacy

Obetix 5 MG (Obeticholic Acid)

Product Name : obetix(Obeticholic Acid)
Generic Name : Obeticholic Acid
Formulation : Tablet
Available Pack Size : 30’s Pot
Available Strengths : 5 mg
Registrations : Export Only

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Product Information

Obetix (Obeticholic Acid) 5mg is a potent and selective Farnesoid X Receptor (FXR) agonist used to treat Primary Biliary Cholangitis (PBC) in adult patients who have had an inadequate response to Ursodeoxycholic Acid (UDCA) or who are unable to tolerate UDCA. It works by activating the Farnesoid X nuclear receptor, a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways in the liver, thereby reducing toxic bile acid accumulation and suppressing ongoing liver inflammation and damage. Manufactured by Beacon Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.

Basic Product Information of Obetix (Obeticholic Acid) 5mg

Brand Name	Obetix (Obeticholic Acid)
Generic Name	Obeticholic Acid INN
Drug Class	Farnesoid X Receptor (FXR) Agonist
Available Strengths	5mg
Formulation	Film-Coated Tablet
Pack Size	30 Tablets per Pot
Primary Indication	Primary Biliary Cholangitis (PBC), in combination with Ursodeoxycholic Acid (UDCA) or as monotherapy
Regulatory Approvals	Originator molecule received USFDA Accelerated Approval and EMA Conditional Marketing Authorisation for Primary Biliary Cholangitis. Regulatory status varies by region. Please consult your local regulatory authority for the current approval status in your country.
Originator Brand	Ocaliva by Intercept Pharmaceuticals (now part of Alfasigma)
Manufacturer	Beacon Pharmaceuticals Ltd., Mymensingh, Bangladesh
Global Supplier	Mediaid Pharmacy, Worldwide Shipping Available
Registration Status	Export Only
Storage Conditions	Store below 30 degrees Celsius. Keep in a dry place away from light and moisture. Keep out of the reach of children.

How Obetix (Obeticholic Acid) Works

Obetix contains Obeticholic Acid, a potent and selective agonist of the Farnesoid X Receptor (FXR), a nuclear receptor found predominantly in the liver and intestine. FXR is a master regulator of bile acid homeostasis, and its activation controls the synthesis, transport, and detoxification of bile acids within the body. In Primary Biliary Cholangitis, the bile ducts inside the liver are progressively destroyed by the immune system, causing toxic bile acids to accumulate in liver tissue and drive ongoing inflammation, fibrosis, and liver damage.

Obeticholic Acid works by binding to and activating FXR in the liver and intestine. Activation of FXR reduces the concentration of bile acids in the liver by suppressing their synthesis from cholesterol through the CYP7A1 pathway, while simultaneously promoting their transport out of liver cells and increasing their excretion. In addition, FXR activation reduces hepatic inflammation and fibrogenesis, protecting liver cells from further bile acid-induced injury.

Clinically, treatment with Obeticholic Acid has been shown to significantly reduce alkaline phosphatase (ALP) and bilirubin levels, which are the primary biochemical markers used to assess disease severity and predict long-term outcomes in PBC. Obetix is taken as a convenient once-daily oral tablet, either alone or in combination with Ursodeoxycholic Acid (UDCA), the established first-line therapy for PBC.

Indications for Obetix (Obeticholic Acid)

Obetix (Obeticholic Acid) is indicated for the following conditions:

PBC in Combination with UDCA

For adult patients with Primary Biliary Cholangitis who have had an inadequate response to Ursodeoxycholic Acid (UDCA). In this setting, Obeticholic Acid is added to UDCA therapy to achieve further reductions in alkaline phosphatase and bilirubin, the key biochemical markers of disease activity and progression.

PBC as Monotherapy

For adult patients with Primary Biliary Cholangitis who are unable to tolerate UDCA. In this setting, Obeticholic Acid is used as a standalone treatment to control bile acid levels, reduce hepatic inflammation, and slow disease progression in patients for whom the standard first-line agent is not suitable.

Understanding Primary Biliary Cholangitis

PBC is a chronic, progressive autoimmune liver disease in which the small bile ducts in the liver are gradually destroyed. This leads to a build-up of toxic bile acids in the liver, causing inflammation, scarring (fibrosis), and potentially liver failure or the need for transplantation if left untreated.

Biochemical Response and Disease Monitoring

Treatment aims to achieve a meaningful reduction in alkaline phosphatase (ALP) and normalisation or near-normalisation of total bilirubin levels. These biochemical improvements are recognised surrogate markers associated with reduced risk of liver transplantation and improved long-term outcomes in PBC.

Benefits of Obetix (Obeticholic Acid) 5mg

First-in-Class FXR Agonist

Obeticholic Acid was the first Farnesoid X Receptor agonist approved for the treatment of PBC, offering a novel mechanism of action that directly addresses the underlying bile acid dysregulation driving liver damage in this chronic disease.

Significant Biochemical Improvement

Clinical trials demonstrated that Obeticholic Acid significantly reduces alkaline phosphatase and total bilirubin levels in PBC patients, both as an add-on to UDCA and as monotherapy, achieving biochemical endpoints associated with improved long-term prognosis.

Dual Use: Combination or Monotherapy

Obetix can be used alongside UDCA for patients with an inadequate response, or as a standalone treatment for patients who cannot tolerate UDCA, providing flexibility in the clinical management of PBC across different patient profiles.

Affordable Alternative to Ocaliva

Obetix contains the same active ingredient as Ocaliva by Intercept Pharmaceuticals, at a significantly lower cost. This makes long-term treatment for chronic liver disease financially accessible for patients in developing and developed countries alike.

Convenient Once-Daily Oral Dosing

Taken as a single tablet once daily, Obetix offers a simple and convenient oral regimen that can be easily incorporated into a patient’s existing treatment plan, supporting long-term adherence in the management of a chronic liver condition.

WHO-GMP and cGMP Certified

Produced by Beacon Pharmaceuticals Ltd. under strict WHO-GMP, cGMP, and ISO-certified manufacturing standards, ensuring every batch of Obetix meets consistent quality, safety, and efficacy requirements.

How to Take Obetix (Obeticholic Acid)

Route: Oral, taken by mouth

Starting dose: 5mg once daily. After three months, if an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin has not been achieved and the patient is tolerating the medication, the dose may be increased to 10mg once daily (two 5mg tablets) as the maximum recommended dose.

Patients with advanced liver disease: For patients with current or prior evidence of hepatic decompensation (such as ascites, hepatic encephalopathy, or variceal bleeding) or with Child-Pugh Class B or C hepatic impairment, the recommended starting dose is 5mg once weekly. This may be titrated to 5mg twice weekly, and then to a maximum of 10mg twice weekly, based on response and tolerability and under close specialist supervision.

With food: Can be taken with or without food, at the same time each day (or on the same day each week for weekly dosing schedules).

Bile acid binding resins: If taking bile acid binding resins such as cholestyramine, colestipol, or colesevelam, take Obetix at least four to six hours before or after taking the resin, or at as great an interval as possible, to avoid reduced absorption.

Warfarin co-administration: Patients taking warfarin should have their International Normalised Ratio (INR) monitored frequently when starting, adjusting, or stopping Obetix, as Obeticholic Acid may reduce the anticoagulant effect of warfarin.

Renal impairment: No dose adjustment is required for patients with renal impairment.

Paediatric use: The safety and efficacy of Obetix in children and adolescents below 18 years of age have not been established. No data are currently available.

Prescription Hepatology Medication with Important Liver Safety Warnings. Obetix must be used under the supervision of a hepatologist or specialist physician experienced in the management of liver diseases. Incorrect dosing in patients with advanced cirrhosis or hepatic decompensation has been associated with serious liver injury, liver failure, and death. It is critical that the correct dosing schedule is followed, especially in patients with any degree of hepatic impairment. Liver function tests including ALP, bilirubin, and transaminases should be monitored regularly before and during treatment. Report any signs of worsening liver function such as jaundice, dark urine, new or worsening ascites, confusion, or unusual bleeding to your doctor immediately.

Monitoring and Dosage Adjustments

Regular and careful monitoring is essential during Obetix treatment. Your healthcare provider will routinely assess liver function tests including alkaline phosphatase (ALP), total bilirubin, direct bilirubin, transaminases (ALT and AST), and gamma-glutamyl transferase (GGT), both to evaluate treatment response and to detect any signs of liver injury. Monitoring also includes assessment for signs of hepatic decompensation such as new or worsening ascites, hepatic encephalopathy, and variceal bleeding. Lipid profiles should be checked, as changes in cholesterol levels may occur. Patients taking warfarin require frequent INR monitoring. If liver function worsens or clinically significant liver-related adverse events occur, treatment may need to be interrupted, the dose reduced, or therapy stopped permanently. Always attend scheduled blood tests and report any new symptoms to your treating physician.

Drug Interactions and Important Information

Bile acid binding resins such as cholestyramine, colestipol, and colesevelam can reduce the absorption of Obeticholic Acid. If concurrent use is necessary, take Obetix at least four to six hours before or after the resin to minimise this interaction and maintain therapeutic drug levels.

Warfarin and other vitamin K antagonists may show a decreased anticoagulant effect when used with Obeticholic Acid, due to changes in the intestinal absorption of vitamin K. Frequent INR monitoring is essential when starting, adjusting, or stopping Obetix in patients receiving anticoagulant therapy. Obeticholic Acid may also affect the pharmacokinetics of other drugs that are substrates of transporters or are metabolised via CYP enzymes. Always inform your physician of all prescription medicines, over-the-counter products, supplements, and herbal remedies you are taking before starting Obetix.

Side Effects and Precautions

Common Side Effects

Pruritus (itching), the most frequently reported side effect

Fatigue and tiredness

Abdominal pain and discomfort

Joint pain (arthralgia)

Oropharyngeal pain (throat discomfort)

Dizziness

Constipation

Changes in lipid levels including elevated LDL cholesterol

Serious Warnings and Precautions

Hepatic decompensation and liver failure, including fatal cases, have been reported, particularly when prescribed at doses higher than recommended in patients with cirrhosis. Correct dosing is critical.

Liver-related adverse reactions including jaundice, rising bilirubin, and worsening ascites. Discontinue treatment if clinically significant liver injury occurs.

Severe pruritus in some patients may require dose reduction, temporary interruption, or addition of anti-pruritic therapy.

Reduced effectiveness of warfarin and other vitamin K antagonists requiring close INR monitoring.

Not recommended during pregnancy or breastfeeding due to potential risk to the unborn child.

Patients with complete biliary obstruction should not use Obetix.

Use with extreme caution and specialist oversight in patients with any degree of hepatic impairment or prior hepatic decompensation events.

Who Should Use Obetix (Obeticholic Acid)?

Obetix is suitable for adult patients diagnosed with Primary Biliary Cholangitis (PBC) who have had an inadequate biochemical response to UDCA (defined as persistently elevated ALP and/or bilirubin despite at least 12 months of adequate UDCA therapy) or who are unable to tolerate UDCA. It is prescribed and supervised by hepatologists, gastroenterologists, and specialist physicians experienced in the management of chronic liver diseases. A thorough assessment including liver function tests, assessment of hepatic reserve and cirrhosis severity, lipid profiles, and review of all current medications is required before initiating treatment. Obetix is contraindicated in patients with complete biliary obstruction.

Manufacturer: Beacon Pharmaceuticals Ltd.

Beacon Pharmaceuticals Ltd. is a leading pharmaceutical manufacturer based in Mymensingh, Bangladesh, and the number one oncology and specialty medicine company in the country. Beacon is the first company in Bangladesh to export cancer drugs and currently exports to Asia, Africa, Europe, and Latin America. With more than 200 generic drugs and 65 oncology products in its portfolio, Beacon operates under strict WHO-GMP, cGMP, and ISO-certified standards. Obetix is one of Beacon’s specialty hepatology products, offering an affordable and bioequivalent alternative to Ocaliva by Intercept Pharmaceuticals at a fraction of the cost.

Global Supplier: Mediaid Pharmacy with Worldwide Shipping

Mediaid Pharmacy is a trusted global supplier of specialty and hepatology medications. We ensure Obetix (Obeticholic Acid) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.

Why Choose Obetix (Obeticholic Acid) from Mediaid Pharmacy?

Obetix represents an important treatment option for patients with Primary Biliary Cholangitis who need more than UDCA alone. As the generic equivalent of Ocaliva by Intercept Pharmaceuticals, it delivers the same active ingredient, Obeticholic Acid, with the same proven Farnesoid X Receptor agonist mechanism at a dramatically more affordable price. Manufactured by the internationally trusted Beacon Pharmaceuticals Ltd. under WHO-GMP and cGMP standards, and distributed globally by Mediaid Pharmacy, Obetix gives patients worldwide access to high-quality hepatology therapy without the financial burden of brand-name alternatives. For patients and hepatologists seeking a proven, affordable, and accessible Obeticholic Acid option with worldwide delivery, Obetix from Mediaid Pharmacy is the trusted choice.

Frequently Asked Questions About Obetix (Obeticholic Acid)

What is Obetix (Obeticholic Acid) used for?

Obetix (Obeticholic Acid) is a Farnesoid X Receptor (FXR) agonist used to treat Primary Biliary Cholangitis (PBC) in adults. It is prescribed for patients who have had an inadequate response to Ursodeoxycholic Acid (UDCA) or who cannot tolerate UDCA. It works by activating FXR in the liver and intestine to reduce toxic bile acid accumulation, suppress liver inflammation, and slow disease progression.

How should I take Obetix (Obeticholic Acid)?

Obetix is taken orally once daily, with or without food. The starting dose is 5mg once daily for three months. If your biochemical response is inadequate and you are tolerating the medication, your physician may increase the dose to 10mg once daily. For patients with liver cirrhosis or prior hepatic decompensation, a reduced starting dose of 5mg once weekly is used, with careful dose titration under specialist supervision. Always follow your prescribing physician’s exact dosing instructions.

What strength and pack size is Obetix (Obeticholic Acid) available in?

Obetix is available in 5mg film-coated tablets, supplied in a pot of 30 tablets. For patients on the 10mg daily dose, two 5mg tablets are taken once daily. The 5mg tablet also facilitates the reduced weekly dosing schedules required for patients with hepatic impairment.

Is Obetix the same as Ocaliva (Obeticholic Acid by Intercept Pharmaceuticals)?

Yes. Obetix is the generic equivalent of Ocaliva. Both contain the same active ingredient, Obeticholic Acid, in the same dosage form and strength. Obetix is manufactured by Beacon Pharmaceuticals Ltd. in Bangladesh and delivers the same FXR agonist mechanism of action as Ocaliva at a significantly lower cost, making it a more accessible option for patients worldwide.

What are the side effects of Obetix (Obeticholic Acid)?

The most common side effect is pruritus (itching), which can range from mild to severe and may require symptomatic treatment or dose adjustment. Other common side effects include fatigue, abdominal pain, joint pain, dizziness, and constipation. Serious risks include hepatic decompensation and liver failure, particularly if the wrong dose is used in patients with advanced liver disease. Always consult your physician for a complete assessment of your individual risks and benefits before starting treatment.

Can I take Obetix with UDCA or other medications?

Yes. Obetix is commonly used in combination with Ursodeoxycholic Acid (UDCA) for patients with an inadequate response to UDCA alone. However, if you are taking bile acid binding resins such as cholestyramine, you must take Obetix at least four to six hours before or after the resin. Patients on warfarin require frequent INR monitoring when starting, adjusting, or stopping Obetix.

Is Obetix (Obeticholic Acid) safe during pregnancy or breastfeeding?

Obetix is not recommended during pregnancy or breastfeeding due to potential risk to the unborn child. Women of childbearing potential should use effective contraception during treatment. Please inform your doctor before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.

Can I order Obetix (Obeticholic Acid) online with worldwide shipping?

Yes. Mediaid Pharmacy supplies Obetix (Obeticholic Acid) 5mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.

Order Obetix (Obeticholic Acid) 5mg with Worldwide Shipping

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