Ocaliva (Obeticholic acid)

Brand Options

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Brand Name : Ocaliva

Marketing Authorization Holder : Intercept

Prescription Required

 
 

Generic Option

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Generic Name : Obeticholic acid

Manufactured By : Authorized Indian Generic

Prescription Required

 
 

Product Details

Ocaliva

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Brand Ocaliva comes in Non-english packaging - English label and English insert included. Plan in advance - allow us 7 days to ship your medicine

Three Manufacturer are approved to make Ocaliva for Europe: - Almac Pharma Services (Ireland) Limited, Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD , Ireland - Almac Pharma Services, Seagoe Industrial Estate, Portadown, Craigavon, BT63 5UA, United Kingdom - Millmount Healthcare Limited, Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD6, Ireland

Prescription Ocaliva is a treatment for primary biliary cholangitis (PBC), usually alongside of ursodeoxycholic acid (ursodiol). Ocaliva is used by adults who have not responded to ursodeoxycholic acid (ursodiol) alone or who cannot tolerate it.

Ocaliva may lower ALP (alkaline phosphatase) levels which are often caused by liver disease. High ALP levels are a key marker used to track PBC and measuring the effectiveness of treatment. Ocaliva may show a reduction in ALP levels after 2 weeks of treatment. Ongoing studies are being conducted to find out if Ocaliva patients live longer or if their symptoms improve after treatment.

Ocaliva should be taken exactly as prescribed with or without food.

Ocaliva reduces toxic bile build up caused by PBC which damages the liver. Ocaliva increases the flow of bile acids and reduces production of bile acids.

Ocaliva requires simple regular testing for ALP every 3 to 6 months to measure the changes produced by treatment.

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Information about Ocaliva (Obeticholic Acid)

Ocaliva (Obeticholic acid) is a prescription medication used primarily to treat chronic liver conditions, including primary biliary cholangitis (PBC), a progressive autoimmune liver disease. It is an oral drug that acts as a farnesoid X receptor (FXR) agonist, which helps regulate bile acid production and improve bile flow, reducing liver inflammation and preventing damage.

Product Highlights

  • Ocaliva is approved for the treatment of adults with PBC, either in combination with UDCA for those who do not respond adequately or as a standalone treatment for those who cannot tolerate UDCA.

Key Ingredient

  • Obeticholic Acid

Key Benefits

  • Helps reduce serum alkaline phosphatase (ALP) levels and bilirubin levels in patients with PBC, indicating improved liver function.
  • In clinical trials, Obeticholic acid has been shown to slow the progression of PBC, potentially delaying liver cirrhosis and the need for a liver transplant.
  • Offers an option for patients with PBC who do not respond adequately to the first-line treatment, ursodeoxycholic acid (UDCA).
  • Can be used as monotherapy in patients who are unable to tolerate UDCA.

Direction of Use

  • Ocaliva is typically taken as a tablet once a day, with or without food.
  • The dosage depends on whether the patient is also taking UDCA and the patient's liver function. The initial dose is often 5 mg once daily, which may be adjusted depending on the clinical response and tolerability.
  • In patients with moderate to severe liver impairment (Child-Pugh Class B or C), the dose of Ocaliva may need to be reduced to minimize the risk of adverse effects.

Safety Concerns

  • Ocaliva can cause liver injury, especially in patients with severe liver impairment. Liver function should be closely monitored with regular blood tests (e.g., liver enzymes) during treatment.
  • A common side effect, pruritus can be severe and might require dose adjustments or discontinuation.
  • Patients may experience fatigue, especially in the first few weeks of treatment.
  • Ocaliva can increase levels of cholesterol and triglycerides, which should be monitored.
  • It is not known if Ocaliva is safe during pregnancy, so it should be used only if clearly needed, and the potential risks and benefits should be carefully considered.
  • Obeticholic acid can interact with other medications, especially those that affect bile acid metabolism, CYP enzymes, or liver function, so it’s important to inform your healthcare provider about all medications you are taking.

Avoid Ocaliva (Obeticholic Acid) If

  • Patients with severe liver impairment should avoid Ocaliva or use it with extreme caution under close medical supervision.
  • If a patient has a known allergy to Obeticholic acid or any of the ingredients in Ocaliva, they should not take the drug.
  • Those with active gallbladder disease should not take Ocaliva, as bile acid medications may worsen conditions related to gallstones.
  • If a patient experiences intolerable pruritus as a side effect, they may need to stop the medication or adjust the dose.


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