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.
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.
