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Ocaliva
Ocaliva (generic name: obeticholic acid) is a prescription medication used to treat primary biliary cholangitis (PBC) in adults. PBC is a chronic liver disease that causes the bile ducts in the liver to become inflamed, leading to the buildup of bile and damage to the liver. Ocaliva belongs to a class of drugs known as farnesoid X receptor (FXR) agonists, which help reduce bile acid production and improve bile flow, thereby slowing the progression of liver damage. Ocaliva is often prescribed in combination with ursodeoxycholic acid (UDCA) or alone if patients do not respond to UDCA.
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Frequently Asked Questions
How long does it take for Ocaliva to work?
Ocaliva may take several months of consistent use to show improvements in liver function tests and symptoms. Regular monitoring by your healthcare provider is important during this period.
Can Ocaliva be taken with food?
Yes, Ocaliva can be taken with or without food. Follow your doctor’s specific instructions.
Is pruritus (itching) common with Ocaliva?
Yes, itching is one of the most common side effects. Your healthcare provider may adjust your dose or prescribe antihistamines to help manage this symptom.
How does Ocaliva compare to ursodeoxycholic acid (UDCA)?
Ocaliva is typically prescribed when UDCA alone is not effective or tolerated. While UDCA is the first-line treatment for PBC, Ocaliva is an effective second-line therapy, often used in combination with UDCA.
What should I do if I miss a dose of Ocaliva?
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time.
Comprehensive Drug Guide
How Does Ocaliva Work?
Ocaliva works by activating farnesoid X receptors (FXR) in the liver and intestines, which play a crucial role in regulating bile acid production and flow. By activating these receptors, Ocaliva reduces the production of bile acids in the liver and promotes the excretion of bile acids, reducing the buildup of bile and preventing further liver damage. This helps slow the progression of primary biliary cholangitis.
Common Dosages
- 5 mg and 10 mg tablets.
Typical Dosing
- Starting dose: The typical starting dose for adults is 5 mg once daily.
- After 3 months, the dose may be increased to 10 mg once daily, depending on the patient’s response and tolerance.
- For patients with moderate or severe hepatic impairment, the starting dose is 5 mg once weekly, with the possibility of increasing to 5 mg twice weekly or 10 mg twice weekly if tolerated.
Typical Dosing
FDA Approved Indications
- Primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA.
- As monotherapy for patients with PBC who are unable to tolerate UDCA.
Who Shouldn't Take Ocaliva?
- Complete biliary obstruction, as the medication relies on bile flow to work effectively.
- Decompensated cirrhosis or Child-Pugh Class B or C liver disease without close monitoring.
Advice From The Pharmacist
- Take Ocaliva once daily, with or without food. Follow your doctor's instructions about dose adjustments, especially if you have liver problems.
- If you experience itching, a common side effect of Ocaliva, contact your healthcare provider. Your doctor may recommend antihistamines or dose adjustments to manage this side effect.
- Regular liver function tests will be needed to monitor how your liver is responding to the medication, so make sure to attend all follow-up appointments.
- Store Ocaliva at room temperature, away from moisture and heat.
- If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next dose. Do not take two doses at once.
Side Effects of Ocaliva
Common Side Effects
- Pruritus (itching), which is the most frequently reported side effect.
- Fatigue
- Abdominal pain or discomfort
- Joint pain
Uncommon/Severe Side Effects
- Liver decompensation, particularly in patients with advanced cirrhosis.
- Severe itching that does not improve with dose adjustments or antihistamines.
- Hepatotoxicity (liver injury), which may require discontinuation of the drug.
Risks and Warnings of Ocaliva
- Liver Decompensation: Ocaliva can worsen liver function in patients with advanced cirrhosis (Child-Pugh Class B or C). Patients with moderate to severe hepatic impairment should be closely monitored, and the dose should be adjusted accordingly.
- Pruritus: Severe itching is common in patients taking Ocaliva. This may be managed by adjusting the dose or adding antihistamines or bile acid-binding resins.
- Hepatotoxicity: Regular monitoring of liver function tests is required, as Ocaliva can cause or worsen liver injury in some patients, particularly those with pre-existing liver conditions.
Interactions with Ocaliva
Common Drug Interactions
- Bile acid-binding resins (e.g., cholestyramine, colesevelam): These medications can interfere with the absorption of Ocaliva. If you take these, administer Ocaliva at least 4 hours before or 4 hours after the bile acid-binding resin.
- CYP3A inhibitors (e.g., ketoconazole, itraconazole): These medications can increase the levels of Ocaliva in the blood, requiring close monitoring and possible dose adjustments.
- Warfarin: Ocaliva may affect INR levels in patients taking warfarin. INR should be closely monitored, and dose adjustments may be needed.
Alternatives to Ocaliva
- Ursodeoxycholic acid (UDCA): The standard first-line treatment for primary biliary cholangitis.
- Bezafibrate: A medication used off-label in some countries to manage PBC in patients who do not respond adequately to UDCA.
- Obeticholic acid (Ocaliva) can also be used as a monotherapy for PBC when patients cannot tolerate UDCA.
