What Is Ocaliva Used For?
Ocaliva treats adults with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have signs of portal hypertension.
Brand Name(s): Ocaliva
Drug Availability: Prescription
Therapeutic Classification: Farnesoid X receptor (FXR) agonist
Available Generically: No
Controlled Substance: N/A
Administration Route: Oral
Active Ingredient: Obeticholic Acid
Dosage Form(s): Oral tablet
The Fibrotic Liver Disease Consortium suggested that PBC prevalence in the U.S. was 23.9 per 100,000 persons. However, this number can vary by geographic region (where people live) and demographics (ex., age, income, etc.).
How to Take Ocaliva
Take Ocaliva by mouth with or without food as directed by your healthcare provider. If you take Ocaliva with a bile acid sequestrant (ex., cholestyramine, colestipol, or colesevelam), you’ll need to take Ocaliva at least four hours before or four hours after the bile acid sequestrant.
Storage
Store Ocaliva in a closed container at room temperature, away from heat, moisture, and direct light. Do not store in the bathroom.
Keep your medications out of the reach of children and pets, ideally locked in a cabinet or closet.
If you plan to travel with Ocaliva, get familiar with your final destination’s regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, make sure to copy your Ocaliva prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. Ask your pharmacist or healthcare provider if you have any questions about traveling with your medicine.
You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The Food and Drug Administration’s (FDA) website is a potentially helpful resource for knowing where and how to discard all unused and expired drugs. You can also find disposal boxes in your area.
Off-Label Uses
There are no reported off-label uses of Ocaliva.
What Are the Side Effects of Ocaliva?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Fatigue (tiredness)Itchy skin (pruritus)Stomach pain and discomfortRashDizzinessConstipationJoint painEczema
Severe Side Effects
Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or think you have a medical emergency. Serious side effects and their symptoms can include the following:
Signs of an allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing Severe itchy skin (pruritus) Ascites (excess fluid in the stomach area that causes swelling) Jaundice (yellowing of the skin or eyes) Worsening of primary biliary cholangitis (PBG) Signs of liver failure: dark-colored urine or pale stools, nausea, vomiting, loss of appetite, stomach pain or discomfort, fever, chills, change in how much or how often you urinate, dry mouth, increased thirst, dizziness, lightheadedness, rapid weight gain, swelling in your hands, ankles, or feet Death
Due to Ocaliva’s black box warning for severe liver injury, you should immediately report any signs and symptoms of liver failure to your healthcare provider. You may need to stop treatment with Ocaliva.
Long-Term Side Effects
Long-term effects of Ocaliva including cardiovascular events are lacking.
Dosage: How Much Ocaliva Should I Take?
Modifications
The following modifications (changes) should be kept in mind when using Ocaliva:
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets): For treatment of primary biliary cholangitis: Adults—At first, 5 milligrams (mg) once a day for the first 3 months. Your doctor may adjust your dose as needed and tolerated. However, the dose is not more than 10 mg once a day. Children—Use and dose must be determined by your doctor.
Severe allergic reaction: Avoid using Ocaliva if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you’re unsure.
Pregnancy and breast-feeding: There’s not enough scientific evidence to tell whether there would be a risk to your fetus when used during pregnancy or to your child during breastfeeding. If pregnant or breastfeeding, please talk with your healthcare provider before starting Ocaliva.
Children: The safety and effectiveness of using Ocaliva in children have not been established.
Adults over the age of 65: Based on the clinical studies of Ocaliva, no overall differences in safety or effectiveness were found between adults over 65 years and adults less than 65. However, some adults over 65 may be more sensitive to Ocaliva.
Missed Dose
If you miss your dose of Ocaliva, take the dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
Overdose: What Happens If I Take Too Much Ocaliva?
There is limited information available about Ocaliva overdose.
The symptoms of a suspected overdose of Ocaliva include increased liver biochemical tests, ascites, jaundice, portal hypertension, and primary biliary cholangitis flares.
If you think you’re experiencing an overdose or life-threatening symptoms, seek immediate medical attention.
Precautions
What Are Reasons I Shouldn’t Take Ocaliva?
You should not take Ocaliva if you have one of the following:
If someone collapses or isn’t breathing after taking Ocaliva, call 911 immediately.
Check with your doctor right away if you have dark urine or pale stools, fever, chills, change in how much or how often you urinate, dry mouth, increased thirst, dizziness, lightheadedness, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes. These may be symptoms of a serious liver problem.
Check with your doctor right away if you have severe itching skin.
This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you have concerns.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
A known allergic reaction to obeticholic acid or any of its ingredients Complete biliary obstruction (a blockage in the tubes that carry bile from the liver to the gallbladder and small intestine) Decompensated cirrhosis (e. g. , Child-Pugh Class B or C) or a prior decompensation event (the stage of liver failure that begins to show symptoms) that includes: ascites, variceal hemorrhage (bleeding of abnormal veins in the gastrointestinal tract such as the stomach, esophagus, or rectum), hepatic encephalopathy (severe liver disease affecting the brain), or jaundice (yellowing of the skin or eyes) Compensated cirrhosis (stage of liver failure without symptoms) with signs of portal hypertension (high blood pressure in the blood vessel that carries blood from the gastrointestinal tract, gallbladder, pancreas, and spleen to the liver)
Please let your healthcare provider know if you have liver problems, severe itching skin, or high cholesterol levels because taking Ocaliva may worsen your condition.
What Other Medications Interact With Ocaliva?
While taking this medication you should ask your healthcare provider or pharmacist before using any other medicine, including over-the-counter medicines, vitamins and herbal products. Use caution when taking Ocaliva with the following medications:
CyclosporineTheophyllineTizanidineBlood thinners (including warfarin)Bile acid sequestrants
If you are taking bile acid sequestrants like cholestyramine, colestipol, or colesevelam, take Ocaliva at least four hours before or four hours after these medicines.
What Medications Are Similar?
There are no medications that share a similar efficacy profile as Ocaliva.
How Can I Stay Healthy While Taking Ocaliva?
If you’re taking Ocaliva, chances are primary biliary cholangitis has been negatively affecting your quality of life. You may’ve tried different approaches or treatments. While living with primary biliary cholangitis does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:
A known allergic reaction to obeticholic acid or any of its ingredientsComplete biliary obstruction (a blockage in the tubes that carry bile from the liver to the gallbladder and small intestine)Decompensated cirrhosis (e. g. , Child-Pugh Class B or C) or a prior decompensation event (when liver failure begins to show symptoms) that include: ascites, variceal hemorrhage (bleeding of abnormal veins in the gastrointestinal tract such as the stomach, esophagus, or rectum), hepatic encephalopathy (severe liver disease affecting the brain), or jaundice (yellowing of the skin or eyes)Compensated cirrhosis (stage of liver failure without symptoms) with signs of portal hypertension (high blood pressure in the blood vessel that carries blood from the gastrointestinal tract, gallbladder, pancreas, and spleen to the liver. )
Avoid alcohol and medications, including herbal products (ex. , kava) that can cause liver injury. Stay up to date with hepatitis vaccinations and lab testing for liver function. Continue to follow up with your healthcare provider to ensure your success with the treatment of your disease.
