Lowering ALP

Leslie, 58 Joined #TeamOCALIVA in 2017

Getting ALP levels closer to normal can reduce your risk of liver damage

People with primary biliary cholangitis (PBC) have elevated levels of ALP (alkaline phosphatase) in their blood. Since an ALP level above normal could mean an increased risk of liver damage, lowering that number is an important goal of treatment—and a sign that treatment is working.* Most people with PBC take ursodiol (also called ursodeoxycholic acid, or UDCA) first to lower their ALP.

But some people don’t respond well to ursodiol, and their ALP levels remain too high, even if they’re lower than they were before. If you’re treating your PBC, your healthcare team will regularly monitor your ALP level to see how well your treatment is working. If your ALP is still higher than it should be, you may need to do more to lower your risk of liver damage.

OCALIVA is proven to deliver significant, sustained ALP reductions

OCALIVA® (obeticholic acid) is an add-on treatment that works in a unique way to reduce toxic bile acid buildup—it may work to reduce ALP levels even more than ursodiol alone.

OCALIVA has been studied in a clinical trial where people either took OCALIVA and ursodiol together—or OCALIVA by itself (if they couldn’t tolerate ursodiol). Most people in these studies took OCALIVA in combination with ursodiol. Almost half of the people who took OCALIVA were considered “responders” to treatment.

Most people in this study took OCALIVA in combination with ursodiol. People were considered “responders” if:

  • ALP was less than 1.67 times the upper limit of normal*
  • ALP decreased by at least 15%
  • Bilirubin levels were within the normal range

Some people saw a reduction in their ALP levels as early as 2 weeks after starting OCALIVA.

The effectiveness of OCALIVA in these patients is based on a study that showed a reduction in the liver enzyme 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.

  • *Many liver health markers such as ALP have a range of values that are considered normal. The top of that range is called the upper limit of normal.
  • OCALIVA is a prescription medicine used to treat PBC in combination with UDCA in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA.
  • Bilirubin is a separate marker of overall liver health. It is measured with a blood test. Bilirubin levels are more likely to be increased in people with PBC with advanced disease and liver damage.

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“I really wanted to bring down my ALP levels, so this seemed like it could be a good option.”

Leslie, a person living with PBC

Watch and Learn

Hear from a patient and her healthcare team about managing and treating PBC.

Progression of PBC

Understanding how PBC develops

Goals of treatment

What you need to know

I’m on treatment—why are my ALP numbers still high?

Even if you’re already on treatment, there may be more you can do to manage PBC. Choose the discussion guide that best describes you, to help you have the right conversation with your doctor.

Indication and Important Safety Information

What is OCALIVA?

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA. 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.

What is the most important information I should know about OCALIVA?

OCALIVA may cause serious side effects including:

Worsening of liver problems or liver failure, in some cases leading to liver transplant or death, has happened in people with primary biliary cholangitis (PBC) with liver cirrhosis when taking OCALIVA.

Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check your liver. These tests will help your healthcare provider decide if it is safe for you to start taking OCALIVA and safe for you to continue taking OCALIVA.

Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:

  • Swelling of your stomach‑area from a build‑up of fluid; yellowing of your skin or the whites of your eyes; black, tarry, or bloody stools; coughing up or vomiting blood, or your vomit looks like “coffee grounds”; mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality.

Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:

  • Stomach‑area pain; nausea, vomiting, or diarrhea; loss of appetite or weight loss; new or worsening fatigue; weakness; fever and chills; light‑headedness; less frequent urination

Who should not take OCALIVA?

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.

What are the possible side effects of OCALIVA?

OCALIVA may cause serious side effects, including:

  • See “What is the most important information I should know about OCALIVA?”
  • Severe Itching (pruritus). Itching is a common side effect and can sometimes become severe (intense itching or itching over much of your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities and usually needs to be treated. Tell your healthcare provider if you get severe itching or if your itching gets worse.
  • Lower HDL‑C (“good” cholesterol). OCALIVA can lower high levels of HDL‑C. Your healthcare provider will check your cholesterol levels during treatment with OCALIVA.

The most common side effects of OCALIVA include: tiredness; stomach pain and discomfort; rash; joint pain; mouth and throat pain; dizziness; constipation; swelling in your hands, ankles, or feet; fast or irregular heartbeat; fever; changes in how your thyroid gland works; dryness, irritation, redness, crusting or drainage of the skin (eczema).

These are not all the possible side effects of OCALIVA. Call your doctor for medical advice about side effects.

What should I tell my healthcare provider before taking OCALIVA?

Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA.

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.

The risk information provided here is not complete. To learn more, please talk to your healthcare provider.

Please click here for Full Prescribing Information and Medication Guide for OCALIVA.

Available by prescription only.

To report negative side effects of OCALIVA, please contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or you may report to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.