By completing this form, you are agreeing to receive communications from Pharming Healthcare Inc., its affiliates, and their agents and representatives. You may opt out at any time.
Welcome to WordPress. This is your first post. Edit or delete it, then start writing!
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 who weigh 27 kg or greater.
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 under 4 years of age or 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.
Most common adverse reaction (incidence >10%):
Seven (33%) patients 12 years and older (n=21) and 5 (63%) patients 4 to 12 years of age and weighing more than 27 kg or greater (n=8) developed an absolute neutrophil count (ANC) between 500 and 1500 cells/microL after receiving JOENJA. No patients 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.
