Frequently Asked Questions
Want to learn more about OCALIVA?
Introducing OCALIVA
OCALIVA® (obeticholic acid) is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodiol (also called ursodeoxycholic acid or UDCA) in adults who have not responded well enough to ursodiol, or alone for adults who cannot tolerate ursodiol. It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC. It is not known if OCALIVA is safe and effective in children.
Yes.OCALIVA may be taken in combination with ursodiol to help further lower ALP (alkaline phosphatase) levels.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.
If you take a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.
Do not take OCALIVA if you:
- have PBC with liver cirrhosis with symptoms such as fluid in the stomach-area or confusion (decompensated liver cirrhosis) or with abnormalities in certain tests that check your liver.
- have a complete blockage of the bile ducts in your liver or gallbladder.
Starting OCALIVA
Your healthcare provider will determine if OCALIVA is right for you. Once you have a prescription for OCALIVA, you will be contacted by a Care Coordinator from Interconnect® who will help you get started.
The Care Coordinators at Interconnect can help you find out how much of the cost of OCALIVA is covered by your insurance or any applicable financial assistance programs.
Interconnect is committed to providing access to OCALIVA to everyone who qualifies. You can reach out to an Interconnect Care Coordinator to get support for your prescription coverage.
Yes. OCALIVA is a prescription medicine and cannot be accessed without a prescription.
Once prescribed OCALIVA, Interconnect can help you get started.
Side effects
No. The severity of pruritus and fatigue are not related to how far the disease has progressed. In fact, for some people, pruritus gets better as their liver health gets worse. The best way to tell if OCALIVA is working for you is to track your ALP (alkaline phosphatase) level over time. Guidelines recommend that you see your healthcare provider regularly to get your ALP level tested.
Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA. These are not all the possible side effects with OCALIVA. Tell your healthcare provider if you experience any side effect that bothers you or does not go away.
Report to your healthcare provider immediately if you develop worsening symptoms. Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA. These are not all the possible side effects with OCALIVA. Tell your healthcare provider if you experience any side effect that bothers you or does not go away.
To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Taking OCALIVA
OCALIVA can be taken with or without food.
OCALIVA should be stored at 20°–25°C (68°–77°F); excursions permitted to 15°–30°C (59°–86°F).
Talk to your healthcare provider if you miss a dose of OCALIVA.
Tracking ALP
Take a look here to see how OCALIVA works. Your healthcare provider can see if OCALIVA is working for you by tracking the results from your liver function tests. Work with your healthcare provider to follow your progress and to make sure you are taking the dose of OCALIVA that works best to lower your ALP (alkaline phosphatase) level.
Healthcare providers use blood tests to check for different enzymes that act as markers of liver health. For people with primary biliary cholangitis (PBC), very important liver markers include ALP and bilirubin.
Yes. Studies suggest that some people who are already taking ursodiol (also called ursodeoxycholic acid or UDCA) can add OCALIVA to their treatment to further lower their ALP levels.
The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in ALP. There is no clinical information currently available to show if patients treated with OCALIVA live longer or if their symptoms improve. There are ongoing studies to find out how OCALIVA works over a longer period of time.
The information on this page is intended for informational purposes only and does not constitute medical advice. Always consult your healthcare team if you have any questions about your medical condition.
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