Pregnancy & Lactation: Risk data not available
What is Leniolisib?
Leniolisib is used to treat a condition called activated phosphoinositide 3-kinase delta syndrome (APDS) in people 12 years and older.
Leniolisib may also be used for purposes not listed in this medication guide.
Warnings
Tell your doctor if you have or have ever had:
- liver disease.
You will need to take a pregnancy test before treatment with leniolisib.
May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using leniolisib and for at least 1 week after your last dose. Tell your doctor if you become pregnant.
Do not breastfeed while using this medicine, and for at least 1 week after your last dose.
How should I use Leniolisib
Use Leniolisib (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. Use the medicine exactly as directed.
Leniolisib is usually taken twice per day (about 12 hours apart) with or without food.
If you vomit after more than 1 hour of taking leniolisib, do not take another dose. Take your next dose as scheduled.
Use the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.
Leniolisib side effects
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:
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- headache;
- dry or thickened skin, itching, rash; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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.
What other drugs will affect Leniolisib?
Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using leniolisib. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).