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 reasons that are not mentioned in this medication guide.

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 more than 1 hour after taking leniolisib, do not take another dose. Take your next dose as scheduled.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

Tell your doctor if you have or have ever had:

• liver disease.

You will need to take a pregnancy test before starting treatment with leniolisib.

It may harm an unborn baby. Do not use if you are pregnant. Use effective birth control while taking leniolisib and for at least 1 week after your last dose. Inform your doctor if you become pregnant.

Do not breastfeed while taking leniolisib, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Leniolisib may cause serious side effects. Call your doctor right away 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 of leniolisib 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.

Usual Adult Dose for Activated PI3K-Delta Syndrome:

Weight 45 kg or greater: 70 mg orally twice a day Comments:-Doses should be given about 12 hours apart.-There is no recommended dose for patients weighing less than 45 kg. -Pregnancy testing in females of reproductive potential is recommended before starting treatment. Use: For the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)

Usual Pediatric Dose for Activated PI3K-Delta Syndrome:

12 years and older:-Weight 45 kg or greater: 70 mg orally twice a day Comments:-Doses should be given about 12 hours apart. -There is no recommended dose for patients weighing less than 45 kg. -Pregnancy testing in females of reproductive potential is recommended before starting treatment. Use: For the treatment of APDS

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive 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, and varicella (chickenpox).

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Many drugs can affect leniolisib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you are using.