LYNAVOY safety

Common side effects

This table shows the side effects occurring in ≥5% of patients treated with LYNAVOY and occurring more frequently in LYNAVOY group, in the GLISTEN study.

Side Effect	LYNAVOY	Placebo
Diarrhea	62%	18%
Stomach pain	26%	10%
Nausea	10%	9%
Bleeding	9%	3%
Headache	8%	3%
Liver enzymes increased (ALT, AST)	8-9%	<1-3%
Upset stomach	8%	<1%
Gastroesophageal reflux disease	7%	4%
Stomach bloating	7%	5%
Dizziness	6%	3%
Joint pain	6%	5%

Most diarrhea events occurred within the first 20 days of initiating treatment. Of the patients who experienced diarrhea, 96% of them had mild or moderate cases
14% of patients treated with LYNAVOY and 5% of patients treated with placebo stopped treatment due to side effects (eg, diarrhea, stomach pain, and liver enzyme increases)

While you are taking LYNAVOY, your doctor will continue to monitor your liver.

Talk to your doctor if you experience any side effects.

See support

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.

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.

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.