Leniolisib

Generic name: leniolisib [ LEN-i-oh-LIS-ib ]
Brand name: Joenja
Dosage form: oral tablet (70 mg)
Drug class: PI3K inhibitors

Medically reviewed by Drugs.com on Oct 19, 2023. Written by Cerner Multum.

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.

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.

Leniolisib may cause serious side effects. 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 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.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

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 leniolisib, and for at least 1 week after your last dose.

How should I take leniolisib?

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.

Leniolisib dosing information

Usual Adult Dose for Activated PI3K-Delta Syndrome:

Recommended dosage: 70 mg orally twice daily

Comments:
-Should be taken approximately 12 hours apart, with or without food.
-Recommended only for patients weighing 45 kg and above.

Use: For the treatment of adults with activated phosphoinositide 3-kinase delta (PI3K-delta) syndrome (APDS)

Usual Pediatric Dose for Activated PI3K-Delta Syndrome:

Recommended dosage:
-12 years or older weighing 45 kg or greater: 70 mg orally twice daily

Comments:
-Should be taken approximately 12 hours apart, with or without food.

Use: For the treatment of pediatric patients with activated phosphoinositide 3-kinase delta (PI3K-delta) syndrome (APDS)

Related/similar drugs

Joenja

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking 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).

What other drugs will affect leniolisib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, 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 use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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