JOENJA Film-coated tablet Ref.[116590] Active ingredients: Leniolisib

Treatment must be initiated by a physician experienced in the management of primary immune deficiencies.

Posology

The recommended dose is 70 mg leniolisib twice daily approximately 12 hours apart. Joenja is indicated in adults and adolescents 12 years of age and older and weighing 45 kg or more.

Treatment should be continued as long as a benefit is observed or until unacceptable toxicity occurs.

Missed dose

If a dose is missed by more than 6 hours, the patient should not take the missed dose but resume dosing at the next scheduled time.

If vomiting occurs within 1 hour after taking leniolisib, the patient should take another leniolisib tablet as soon as possible. If vomiting occurs more than 1 hour after dosing, the patient should not take an additional dose.

Special populations

Paediatric population

The safety and efficacy of leniolisib in children aged less than 12 years or below the weight of 45 kg have not yet been established. No data are available.

Elderly

There are no data on patients aged 65 years and older. No dosing modifications are recommended for elderly patients.

Renal impairment

Leniolisib has not been studied in patients with renal impairment (creatinine clearance (CrCL) 15 to 89 mL/min). No dosing modifications are recommended for patients with renal impairment.

Hepatic impairment

Leniolisib has not been studied in patients with hepatic impairment. Use of leniolisib in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C) is not recommended.

Method of administration

Oral use.

Joenja can be taken with or without meals. The tablets should be swallowed whole. Do not split, crush, or chew the tablets.

Gastric acid reducing agents

For patients using locally acting antacids chronically, the antacid should be taken either 2 hours before or 2 hours after leniolisib administration (see section 4.5).

If overdose occurs, the patient must be monitored for evidence of toxicity (see section 4.8). Treatment of overdose with leniolisib consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

30 months.

This medicinal product does not require any special storage conditions.

High density polyethylene bottles with aluminium induction seal and child resistant polypropylene screw cap.

Each pack contains 1 bottle with 60 tablets.

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.