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Leniolisib (By mouth)

Leniolisib (len-i-oh-LIS-ib)

Treats activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).

Brand Name(s):

Joenja

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to leniolisib.

How to Use This Medicine:

Tablet

  • Your doctor will tell you how much medicine to use. Do not use more than directed.
  • Missed dose: If you miss a dose and it is more than 6 hours , skip the missed dose and go back to your regular dosing schedule.
  • If you vomit within 1 hour after you take this medicine, take the medicine as soon as possible. If you vomit more than 1 hour after you take this medicine, do not take an extra dose. Take your next dose at your usual time.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some medicines can affect how leniolisib works. Tell your doctor if you are using efavirenz, erythromycin, itraconazole, rifampin, rosuvastatin, or birth control pills.
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment with this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose.
  • Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
  • Tell your doctor if you have liver disease.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blistering, peeling, red skin rash
  • Fast, pounding, or uneven heartbeat
  • Fever, chills, cough, runny or stuffy nose, sore throat, body aches
  • Headache, back or neck pain

If you notice these less serious side effects, talk with your doctor:

  • Diarrhea
  • Hair loss
  • Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 8/4/2025

 
 
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