JOENJA

6). Posology The recommended dosage of Joenja in adult and paediatric 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.

Missed dose If a dose is missed by more than 6 hours, patients should wait and take the next dose at the usual time. If vomiting occurs within 1 hour after taking Joenja, patients should take Joenja as soon as possible. If vomiting occurs more than 1 hour after dosing, patients should wait and take the next dose at the usual time.

, carbamazepine, efavirenz, nevirapine, phenobarbital, phenytoin, rifabutin, rifampin, St. 5). Special populations Elderly Because clinical studies of Joenja did not include any patients 65 years of age and older, it cannot be determined whether they respond differently from younger adult patients.

Paediatric population The safety and effectiveness of Joenja have not been established in paediatric patients below the age of 12 years. There is no recommended dosage for paediatric patients 12 years of age and older who weigh less than 45 kg.

Patients with hepatic impairment Leniolisib is extensively (60%) metabolized by the liver. The effect of hepatic impairment on the pharmacokinetics of leniolisib has not been studied. 2). Method of administration Oral use. Joenja can be taken with or without meals.

The tablets should be swallowed whole. The tablets should not be split, crushed, or chewed.

The safety of Joenja reflects exposure based on 38 adult and paediatric patients 12 years of age and older with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) from the placebo-controlled portion of Study 2201 and additional open-label clinical safety data.

Thirty-seven of 38 patients received Joenja 70 mg orally twice daily for at least 60 weeks and 81% were exposed for 96 weeks or longer. Median duration of Joenja treatment was approximately 3 years, and 5 patients had more than 5 years of Joenja exposure.

The data below are based on the 12-week, placebo-controlled portion of Study 2201 in which either Joenja 70 mg (N=21) or placebo (N=10) was administered twice daily to patients with APDS. 1. Table 1 presents adverse reactions that occurred in 2 or more patients treated with Joenja and for which the incidence in patients treated with Joenja was greater than the incidence in patients treated with placebo.

The most common adverse reactions (> 10%) were headache, sinusitis, and atopic dermatitis. Adverse reactions are listed in Table 1 by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), and rare (≥ 1/10 000 to < 1/1 000), and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 5 x 109/L). 5 x 109/L) and there were no reports of infection associated with neutropenia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.

Embryo-foetal toxicity Based on findings in animals, Joenja may cause foetal harm when administered to a pregnant woman. Administration of leniolisib to rats and rabbits during the period of organogenesis caused embryo-foetal toxicity including malformations at exposures that were 2 to 6 times higher than the maximum recommended human dose (MRHD) in APDS patients based on AUC comparisons.

The pregnancy status of patients of reproductive potential should be verified prior to starting treatment. Pregnant women should be advised of the potential risk to a foetus. Females of reproductive potential should be advised to use highly effective methods of contraception during treatment and for 1 week after the last dose.

Vaccinations Live, attenuated vaccinations may be less effective if administered during Joenja treatment. Excipients with known effect Lactose content This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption must not take this medicine.

Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

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