Seladelpar (Oral)
Seladelpar is used in adults alone or in combination with ursodeoxycholic acid (ursodiol) to treat primary biliary cholangitis (PBC).
Seladelpar may also be used for purposes not listed in this medication guide.
uses
What is Seladelpar (Oral) used for?
- Primary Biliary Cholangitis
warnings
What is the most important information I should know about Seladelpar (Oral)?
Tell your doctor if you have or have ever had:
- problems with your bile duct, such as biliary obstruction; or
- cirrhosis or severe liver disease.
You may be more likely to have a broken bone while using seladelpar. Talk with your doctor about ways to keep your bones healthy.
It is not known if seladelpar will harm an unborn baby. Tell your doctor right away if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Seladelpar (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sudden or unusual pain;
- trouble moving your hip, thigh, wrist, or back; or
- liver problems--abnormal liver function tests, swelling around your midsection, loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your treatment may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- headache, stomach pain;
- nausea, bloating; or
- dizziness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Seladelpar (Oral) if I’m pregnant or breastfeeding?
It is not known if seladelpar will harm an unborn baby. Tell your doctor right away if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Seladelpar (Oral)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Seladelpar (Oral)?
Use Seladelpar (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Never use seladelpar in larger amounts, or for longer than prescribed. Use the medicine exactly as directed.
Seladelpar is usually taken once per day with or without food.
You will need frequent blood tests to check your liver function before and during treatment with seladelpar. Your next dose may be delayed or permanently discontinued based on the results.
Call your doctor if your symptoms do not improve, or if they get worse.
Store at room temperature, away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Overdose Signs
What happens if I overdose on Seladelpar (Oral)?
Images
CBAY, 10
Color: blue/gray
Shape: capsule
Imprint: CBAY, 10