Overdose : מינון יתר

11     OVERDOSAGE
If overdosage occurs, monitor the patient for any signs or symptoms of adverse reactions. Treatment of overdose with JOENJA consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.


12     DESCRIPTION
Leniolisib is a kinase inhibitor. The chemical name for leniolisib phosphate is 1-[(3S)-3- [[5,6,7,8-Tetrahydro-6-[6-methoxy-5-(trifluoromethyl)-3-pyridinyl]pyrido[4,3-d]pyrimidin- 4-yl]amino]-1-pyrrolidinyl]-1-propanone phosphate (1:1).
Leniolisib phosphate has the following structural formula:



The molecular formula is C21H25F3N6O2•H3PO4 and the molecular weight is 450.47 g/mol for the free base, 548.46 g/mol for the phosphate salt.
Leniolisib phosphate is a white to yellowish to yellowish-greenish powder. The aqueous solubility of leniolisib phosphate is pH dependent with decreasing solubility observed with increasing pH.
JOENJA film-coated tablets are for oral administration. Each tablet contains 70 mg of leniolisib (equivalent to 85.26 mg leniolisib phosphate) with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropyl methylcellulose, magnesium stearate and colloidal silicon dioxide. The tablet film-coating (Opadry® 00F220015 yellow) contains Hypromellose/hydroxypropyl methylcellulose (HPMC 2910), titanium dioxide (E171), talc, macrogol/polyethylene glycol, iron oxide yellow (E172) and iron oxide red (E172).
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’.