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Ocaliva is a medicine that is used alone or in combination with another medicine called ursodeoxycholic acid to treat primary biliary cholangitis (long-term disease of the liver that slowly destroys the bile ducts within the liver).
How does this medication work?
Ocaliva works by limiting the amount of bile in the liver and promoting the flow of bile from the liver.
What are the beneficial effects of this medication and when should I begin to have results?
What: Ocaliva may prevent liver disease or damage to the liver, as measured by certain tests commonly used by healthcare providers to evaluate liver function.
When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's instructions. It is important that you take Ocaliva exactly as your healthcare provider has prescribed.
How do I know it is working?
Your healthcare provider may order certain tests regularly to check how well this medication is working.
The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.
More common side effects may include: itching, tiredness, abdominal (stomach area) pain and discomfort, rash, mouth/throat pain, dizziness, constipation, joint pain, abnormal thyroid function, eczema.
Less common side effects may include:
Liver problems, with symptoms such as yellowing of your skin or the whites of your eyes, dark or brown (tea color) urine, nausea or vomiting, feeling tired or weak, or loss of appetite. Your healthcare provider should do blood tests to check your liver function during treatment.
Ocaliva may also cause changes in cholesterol (fats in your blood) levels.
Do not take Ocaliva if you are allergic to it or any of its ingredients.
Do not take Ocaliva if you have complete biliary obstruction (complete blockage in the tubes that carry bile from the liver to the gallbladder and small intestine).
Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Ocaliva. Also, talk to your healthcare provider about your complete medical history, especially if you have liver problems, have high cholesterol levels, are pregnant, plan to become pregnant, or are breastfeeding.
The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.
Adults: The recommended starting dose is 5 milligrams once a day. Your healthcare provider may increase your dose as needed, until the desired effect is achieved.
If you have liver problems, your healthcare provider may adjust your dose appropriately.
Take Ocaliva exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Ocaliva without first talking to your healthcare provider.
Take Ocaliva with or without food.
Tell your healthcare provider if you experience itching or an increase in the severity of itching. Your healthcare provider may need to adjust your dose.
If you are taking another medicine called a bile acid resin (such as cholestyramine, colestipol, and colesevelam), take Ocaliva at least 4 hours before or 4 hours after taking the bile acid resin.
Do not miss any scheduled follow-up appointments with your healthcare provider. You may need to have blood tests done to check for changes in your cholesterol levels during treatment with Ocaliva.
If Ocaliva is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your healthcare provider before combining Ocaliva with the following: bile acid resins, tizanidine, theophylline, and warfarin.
The effects of Ocaliva during pregnancy and breastfeeding are unknown. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
If you miss a dose of Ocaliva, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.
Store at room temperature.
In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222
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