Ocaliva

Ocaliva is a prescription medication used to treat primary biliary cholangitis. 

Ocaliva is a semi-synthetic derivative of bile acid. This drug works by binding to a receptor in the liver, intestines, kidney, and adipose tissue and changing the body’s metabolism of lipids.

This medication is available as a tablet and is typically taken once a day, with or without food. 

Common side effects of Ocaliva include itching, fatigue, stomach pain, joint pain, throat pain, and constipation. Ocaliva may cause dizziness. Do not drive or operate heavy machinery until you know this medication affects you. 

Ocaliva is a prescription medication used to treat primary biliary cholangitis. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ocaliva. See the “Ocaliva Precautions” section.

Common side effects of Ocaliva include the following:

• severe itching of the skin
• fatigue
• abdominal pain and discomfort
• rash
• pain in the middle part of the throat
• dizziness
• constipation
• joint pain
• thyroid function abnormality
• eczema

This is not a complete list of Ocaliva side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• bile acid binding resins such as cholestyramine, colestipol, or colesevelam. If taking a bile acid binding resin, take Ocaliva at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible.
• warfarin
• CYP1A2 substrates with a narrow therapeutic index such as theophylline and tizanidine (Zanaflex)

This is not a complete list of Ocaliva drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Ocaliva including the following: 

• Liver-Related Adverse Reactions. Liver-related adverse reactions including jaundice (yellow pigmentation of skin and whites of the eyes), worsening ascites (accumulation of fluid in the stomach) and primary biliary cholangitis flare (sudden worsening of PBC symptoms) have been observed in clinical trials, as early as one month after starting treatment with Ocaliva 10 mg once-daily up to 50 mg once-daily (up to 5-times the highest recommended dosage). Your healthcare provider may do blood tests periodically during your treatment with Ocaliva to check how well your liver is working. Report to your healthcare provider immediately if you develop any symptoms of worsening liver disease.

• Severe Pruritus (itching). Cases of severe pruritus have occurred in patients being treated with Ocaliva. Severe pruritus consists of intense or widespread itching, interfering with activities of daily living, or causing severe difficulty in staying asleep, or intolerable discomfort, and typically requiring medical interventions. Your healthcare provider may recommend taking bile acid resins or antihistamines, Ocaliva dosage reduction, and/or temporary interruption of Ocaliva dosing to help manage the symptoms of severe pruritus. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with Ocaliva.
• Decreases in HDL-C Cholesterol. Decreases in HDL-C (good cholesterol) have been observed in patients taking Ocaliva. Your healthcare provider may check your lipid levels periodically during your treatment with Ocaliva.

Do not take Ocaliva if you:

• are allergic to Ocaliva or to any of its ingredients
• have complete biliary obstruction

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ocaliva, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Ocaliva, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Ocaliva or to any of its ingredients
• have low HDL-C (good cholesterol)
• have complete biliary obstruction

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Ocaliva. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Ocaliva crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ocaliva.

Take Ocaliva exactly as prescribed.

Ocaliva comes in tablet form and is taken by mouth, once daily, with or without food.

For patients taking bile acid binding resins, take Ocaliva at least 4 hours before or 4 hours after taking a bile acid binding resin, or at as great an interval as possible.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose range of Ocaliva for the treatment of primary biliary cholangitis is 5-10 mg by mouth once daily. 

The recommended dose and schedule differs based on disease state and Child-Pugh classification. 

Non-cirrhotic or Child-Pugh Class A, the recommended doses are:

• Starting dosage for first 3 months: Ocaliva 5 mg by mouth once daily
• Dose titration after first 3 months: Ocaliva 10 mg by mouth once daily
• Maximum dosage: Ocaliva 10 mg by mouth once daily

Child-Pugh Class B or C or have had a decompensated event, the recommended doses are:

• Starting dose for first 3 months: Ocaliva 5 mg by mouth once weekly
• Dose titration after first 3 months: Ocaliva 5 mg by mouth twice weekly (at least 3 days apart). May increase dose to 10 mg by mouth twice weekly (at least 3 days apart) based on response and tolerability. 
• Maximum dosage: Ocaliva 10 mg by mouth twice weekly (at least 3 days apart)

If you take too much Ocaliva, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 20°C-25°C (68°F-77°F)
• Do not keep medicine that is out of date or that you no longer need.
• Keep Lipitor and all medicines out of the reach of children. Be sure that if you throw medicine away, it is out of the reach of children.

Warning: Hepatic decompensation and failure in incorrectly dosed PBC patients with Child-Pugh Class B or C or decompensated cirrhosis.

• In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when Ocaliva was dosed more frequently than recommended.
• The recommended starting dosage of Ocaliva is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.