Introducing OCALIVA® (obeticholic acid)
- What is OCALIVA, and who can take it?
- OCALIVA is a pill that can be prescribed for adults who have PBC. It can be taken in combination with another medicine called ursodeoxycholic acid (UDCA). For people who cannot tolerate UDCA, OCALIVA can be taken alone.
- Can I take OCALIVA if I am already taking UDCA to treat my PBC?
- Yes. OCALIVA may be taken in combination with UDCA to help further lower alkaline phosphatase (ALP) levels.
- Can I take OCALIVA if I am taking other medicines?
- Some medicines used to lower blood cholesterol levels, so-called bile acid resins (including cholestyramine, colestipol and colesevelam) may reduce the effectiveness of OCALIVA. If you are taking a bile acid resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid resin, or at as great an interval as possible. Certain drugs such as warfarin and CYP1A2 substrates (including theophylline and tizanidine) can interact with OCALIVA, so it is important to tell your healthcare provider about all the medicines you take.
- Who should not take OCALIVA?
- Do not take OCALIVA if you have or had a complete blockage in the bile ducts in your liver or gall bladder. Talk to your healthcare provider to see if OCALIVA is right for you.
- Who can help me get started on 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.
- How much will OCALIVA cost me?
- 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.
- How can I find out if my insurance will cover my OCALIVA prescription?
- 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.
- Do I have to go to my healthcare provider to get OCALIVA?
- Yes. OCALIVA is a prescription medicine and cannot be accessed without a prescription.
- Who can I talk to if I have other questions about getting started on OCALIVA?
- Once prescribed OCALIVA, Interconnect can help you get started.
- If I experience pruritus (itching of the skin) while I’m on OCALIVA, does that mean it’s not working?
- 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 alkaline phosphatase (ALP) level over time. Guidelines recommend that you see your healthcare provider regularly to get your ALP level tested.
- What should I do if I experience pruritus while taking OCALIVA?
- Be sure to tell your healthcare provider if pruritus develops or worsens during treatment with OCALIVA. These are not all the possible side effects associated with OCALIVA. Tell your healthcare provider if you experience any side effect that bothers you or does not go away.
- What should I do if I experience any side effects while taking OCALIVA?
- 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 associated 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.
- Do I need to take OCALIVA with food?
- OCALIVA can be taken with or without food.
- How should I store OCALIVA?
- OCALIVA should be stored at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F).
- What should I do if I miss a dose of OCALIVA?
- Talk to your healthcare provider if you miss a dose of OCALIVA.
- How does OCALIVA work, and how will I know if it is working for me?
- 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 alkaline phosphatase (ALP) level.
- What are “liver markers”?
- Healthcare providers use blood tests to check for different enzymes that act as markers of liver health. For people with PBC, very important liver markers include ALP and bilirubin.
- Can OCALIVA help people who have already lowered their ALP levels with another medicine?
- Yes. Studies suggest that some people who are already taking ursodeoxycholic acid (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 the liver 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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