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LYNAVOY is the first and only FDA-approved medication for cholestatic pruritus (itch) in patients with PBC

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Cholestatic pruritus, also known as PBC itch, affects most patients with PBC. It can be a persistent, debilitating itch associated with the liver disease.

FDA=Food and Drug Administration; PBC=primary biliary cholangitis.

Previously, there were no FDA-approved medications to treat PBC itch.
LYNAVOY is specially designed to treat PBC itch.

How does LYNAVOY work?

LYNAVOY helps reduce bile acid levels in the body.

Small intestine icon

The small intestine normally reabsorbs bile acids, initially produced in the liver, so they can be used again.

Bile acid icon

In patients with PBC, bile acids can build up in the blood and be a root cause of itching.

Bile acid reabsorption blocker icon

LYNAVOY blocks this reabsorption process to allow more bile acids to leave the body.

Bile acid reduction icon

LYNAVOY helps reduce the bile acids associated with cholestatic pruritus in PBC.

  • The cause of itch in patients with PBC is not completely understood
  • Exactly how LYNAVOY works to treat PBC itch is not fully understood
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LYNAVOY may cost less than you think

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Important Safety Information

Before using LYNAVOY, 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 LYNAVOY will harm your unborn baby.
  • Pregnancy Safety Study: Pregnancy outcomes in women who become pregnant while using LYNAVOY is being collected. The purpose of this is to collect information about your health and your baby’s health. You or your healthcare provider should report your pregnancy by calling 1-888-825-5249.
  • are breastfeeding or plan to breastfeed. It is not known if LYNAVOY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using LYNAVOY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNAVOY and certain other medicines may interact with each other. Especially tell your healthcare provider if you take:

  • bile acid binding resins (used to reduce absorption of bile acids from the intestine), such as cholestyramine or colesevelam. These may reduce the effects of LYNAVOY. If you take any of these medicines, take LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin.

What are the possible side effects of LYNAVOY?

LYNAVOY may cause serious side effects, including:

  • Increased liver enzymes. An increase in liver enzymes (liver-related blood tests) can happen in people who use LYNAVOY and can be serious. Your healthcare provider will do blood tests to check your liver before starting treatment and during treatment with LYNAVOY. Your healthcare provider may need to stop your treatment with LYNAVOY because of an increase in liver enzymes.
  • Diarrhea. Diarrhea can happen in people who use LYNAVOY and can be serious. Diarrhea can cause a loss of body fluid (dehydration). Check for signs of dehydration including thirst, dry mouth, urinating less often, or headache. Call your healthcare provider if you have diarrhea that does not go away.
  • Fat-Soluble Vitamin (FSV) Deficiency. A condition called FSV deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat, can happen with LYNAVOY. Your healthcare provider will do blood tests for FSV deficiency before starting and during treatment with LYNAVOY. People with FSV deficiency can bleed more easily or bleed longer or may develop bone fractures. Call your healthcare provider if you have bleeding problems or a bone fracture while using LYNAVOY.
  • The most common side effects of LYNAVOY include:
    • diarrhea
    • stomach pain
    • nausea
    • bleeding
    • increased liver enzymes (ALT, AST)
    • headache
    • upset stomach
    • gastroesophageal reflux disease
    • stomach bloating
    • dizziness
    • joint pain

These are not all the possible side effects of LYNAVOY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information for LYNAVOY.

What is LYNAVOY?

  • LYNAVOY is a prescription medicine used to treat itching (pruritus) in adults with primary biliary cholangitis (PBC).
  • LYNAVOY is not for use in people with severe liver disease (decompensated cirrhosis), or people who have or have had certain liver-related problems including bleeding of enlarged blood vessels in the stomach-area (variceal hemorrhage), fluid in the stomach-area (ascites), or nervous system problems (such as confusion, slurred speech, sluggish movements) caused by severe liver disease (hepatic encephalopathy).
  • It is not known if LYNAVOY is safe and effective in children.

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