Joenja

JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

• Verify pregnancy status in females of reproductive potential prior to initiating treatment. (
  2.1 Testing Prior to Treatment with JOENJA

  Verify pregnancy status in females of reproductive potential prior to initiating treatment with JOENJA

  [see Warnings and Precautions , and Use in Specific Populations ]

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  5.1 Embryo-Fetal Toxicity

  Based on findings in animals, JOENJA may cause fetal harm when administered to a pregnant woman. Administration of leniolisib to rats and rabbits during the period of organogenesis caused embryo-fetal toxicity including malformations at exposures that were 2-6 times higher than the maximum recommended human dose (MRHD) in APDS patients based on AUC comparisons. Verify the pregnancy status of patients of reproductive potential prior to starting treatment. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use highly effective methods of contraception during treatment and for 1 week after the last dose

  [see Dosage and Administration , Use in Specific Populations ]

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• Recommended dosage: 70 mg administered orally twice daily approximately 12 hours apart, with or without food, in adult and pediatric patients 12 years of age and older and weighing ≥ 45kg. (
  2.2 Recommended Dosage and Administration

  The recommended dosage of JOENJA in adult and pediatric patients 12 years of age and older weighing 45 kg or greater is 70 mg administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.

  Advise patients that if a dose is missed by more than 6 hours, wait and take the next dose at the usual time.

  Advise patients that if vomiting occurs within 1 hour after taking JOENJA, take JOENJA as soon as possible. If vomiting occurs more than 1 hour after dosing, wait and take the next dose at the usual time.
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Tablets: 70 mg (leniolisib), yellow, oval-shaped, biconvex, bevelled edge film-coated tablet debossed with "70" on one side and "LNB" on the other side.

• Lactation: Advise women not to breastfeed. (
  8.2 Lactation

  Risk Summary

  There are no data on the presence of leniolisib or its metabolites in human milk or the effects on the breastfed infant or milk production. Leniolisib is present in rat milk (

  see Data

  ). When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions from leniolisib in the breastfed child, advise women not to breastfeed during treatment with JOENJA and for 1 week after the last dose.

  Data

  Animal Data

  Leniolisib was present in the milk of lactating rats administered oral doses of 10, 30, and 90 mg/kg/day from gestation day 7 through postnatal day 21. Leniolisib concentrations were approximately 2- to 3-fold higher in milk than in maternal plasma. The concentration of leniolisib in animal milk does not necessarily predict the concentration of drug in human milk.
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• Hepatic impairment: Use in patients with moderate to severe hepatic impairment is not recommended. (
  8.6 Hepatic Impairment

  Leniolisib is extensively (60%) metabolized by the liver. The effect of hepatic impairment on the pharmacokinetics of leniolisib has not been studied. The use of JOENJA in patients with moderate to severe hepatic impairment is not recommended

  [see Clinical Pharmacology ]

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