Discover Ocaliva: Uses, Dosage, Side Effects & Essential Info

Ocaliva (obeticholic acid) is a prescription medication available in oral tablet form, primarily used to manage primary biliary cholangitis (PBC) in adults without specific liver complications.

PBC is an autoimmune disorder in which the immune system attacks the bile ducts in the liver, causing bile to accumulate and potentially damage the liver over time. Early signs of PBC often include fatigue, itchy skin, and dryness of the mouth or eyes.

Key Facts About Ocaliva

Ocaliva contains the active compound obeticholic acid and is currently available only as a brand-name drug, with no generic versions on the market.

It carries a boxed warning from the FDA, indicating serious risks associated with its use in certain liver conditions. More details are provided in the safety considerations below.

Purpose of Ocaliva

Indications

This medication is prescribed for adults with PBC who either do not have cirrhosis or have compensated cirrhosis without portal hypertension. It is often used alongside ursodiol when ursodiol alone is insufficient, or as a standalone treatment for those who cannot tolerate ursodiol.

Mechanism of Action

Ocaliva activates the farnesoid X receptor (FXR) in the liver and intestines, regulating bile acid production and metabolism. By reducing bile acid synthesis and promoting bile acid clearance, it helps prevent liver damage caused by bile buildup.

Potential Side Effects of Ocaliva

Side effects can range from mild to serious and may vary based on individual health factors and concurrent medications.

Common Mild Side Effects

• Skin itchiness
• Fatigue
• Abdominal discomfort
• Rash
• Sore throat
• Dizziness
• Constipation
• Joint pain

Serious Side Effects

• Severe or worsening skin itchiness
• Significant reduction in good cholesterol (HDL) levels
• Risk of worsening liver function and liver failure in patients with cirrhosis (boxed warning)

Allergic reactions, although not reported in clinical trials, may occur and require immediate medical attention if symptoms like swelling or breathing difficulties arise.

Dosage and Administration

Ocaliva is available in 5 mg and 10 mg tablets. The typical starting dose is 5 mg once daily, which may be increased to 10 mg after three months based on treatment response and tolerability.

Usage Tips

• Tablets should be swallowed whole; consult your healthcare provider if you have difficulty swallowing.
• Can be taken with or without food.
• Take at the same time each day to maintain consistent drug levels.
• If a dose is missed, take it as soon as remembered unless it is near the time of the next dose; do not double dose.
• Long-term use is common and should be regularly evaluated by your doctor.

Overdose Information

An overdose may worsen liver symptoms such as abdominal swelling, jaundice, or increased liver enzymes. Seek immediate medical help if overdose is suspected.

Important Precautions Before Using Ocaliva

Drug Interactions

Ocaliva can interact with medications like bile acid sequestrants, warfarin, theophylline, tizanidine, and cyclosporine. Inform your healthcare provider about all medications and supplements you are taking to avoid harmful interactions.

Alcohol and Caffeine Considerations

While alcohol does not directly interact with Ocaliva, it may exacerbate PBC symptoms. Caffeine intake may need to be limited during treatment.

Pregnancy and Breastfeeding

Safety during pregnancy and breastfeeding is not established. Consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

Boxed Warning Details

Ocaliva carries a serious FDA boxed warning regarding the risk of liver deterioration and failure in patients with advanced liver scarring (cirrhosis). It is not recommended for patients with decompensated cirrhosis or compensated cirrhosis with portal hypertension. Regular monitoring through blood tests is essential.

Frequently Asked Questions About Ocaliva

FDA Approval Status

Ocaliva received accelerated FDA approval in 2016 for treating PBC based on its ability to reduce alkaline phosphatase (ALP) levels, a liver enzyme marker. Full approval awaits further studies confirming clinical benefits.

Use for NASH

Ocaliva is not FDA-approved for nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). It is specifically indicated for PBC.

Cost and Savings Options

The price of Ocaliva can vary based on insurance coverage and pharmacy. Assistance programs, including copay cards provided by the manufacturer Intercept Pharmaceuticals, may help eligible patients reduce costs. Consult your healthcare provider or pharmacist for options.

Alternative Treatments for PBC

Other medications for PBC include ursodiol (ursodeoxycholic acid), elafibranor, and seladelpar. Discuss with your doctor to determine the best treatment plan.

Disclaimer: This information is intended to supplement, not replace, professional medical advice. Always consult your healthcare provider for personalized guidance and before starting any new medication.

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