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Indications and Usage
JOENJA® (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 4 years of age and older and weighing 27 kg or more.
Important Safety Information
Verify pregnancy status in females of reproductive potential prior to initiating treatment with JOENJA.
JOENJA may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus and to use highly effective methods of contraception during treatment with JOENJA and for 1 week after the last dose. Additionally, advise women not to breastfeed during treatment with JOENJA and for 1 week after the last dose.
Live, attenuated vaccinations may be less effective if administered during JOENJA treatment.
JOENJA may cause hypersensitivity reaction(s), including anaphylaxis. Advise patients to discontinue JOENJA and to seek immediate medical attention if they develop any signs and symptoms of serious allergic reactions.
Use of JOENJA in patients with moderate to severe hepatic impairment is not recommended. There is no recommended dosage for patients weighing less than 27 kg.
Avoid co-administration of JOENJA with other medications known to be strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, or BCRP, OATP1B1, and OATP1B3 substrates.
Adult and pediatric patients 12 years of age and older: The most common adverse reactions (incidence >10%) seen in clinical trials were headache, sinusitis, atopic dermatitis, and weight gain.
Pediatric patients 4 to 11 years of age: The most common adverse reactions (incidence > 10%) were headache, cough, pyrexia, vomiting, diarrhea, and sinusitis.
Seven (33%) patients in the adult and pediatric patients 12 years and older (Study 2201) and 10 (47.6%) of pediatric patients 4 to 11 years of age (Study 3301 Part 1) receiving JOENJA developed an absolute neutrophil count (ANC) between 500 and 1500 cells/microL. No patients in either study developed an ANC <500 cells/microL and there were no reports of infection associated with neutropenia.
Before prescribing JOENJA, please read the full Prescribing Information.
Joenja is available in 40 mg, 50 mg, and 70 mg tablets.
