Idelalisib

SPC section 4.2: the recommended dose is 150 mg idelalisib twice daily. Treatment should be conducted by a physician experienced in the use of anti-cancer therapies. MISSED DOSE: if missed within 6 hours of the usual time, take it as soon as possible and resume the normal schedule; if missed by more than 6 hours, do not take the missed dose and simply resume the usual schedule. DOSE MODIFICATION — ELEVATED LIVER TRANSAMINASES: withhold for Grade 3 or 4 aminotransferase elevation (ALT/AST greater than 5 x ULN); once values return to Grade 1 or below (ALT/AST 3 x ULN or less) treatment can be resumed at 100 mg twice daily, with re-escalation to 150 mg twice daily at the physician's discretion if the event does not recur; if it recurs, withhold again until values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered. DIARRHOEA/COLITIS: withhold for Grade 3 or 4; once returned to Grade 1 or below resume at 100 mg twice daily, re-escalating to 150 mg twice daily if it does not recur. PNEUMONITIS: withhold for suspected pneumonitis; once resolved and if re-treatment is appropriate, resumption at 100 mg twice daily can be considered; permanently discontinue for moderate or severe symptomatic pneumonitis or organising pneumonia. RASH: withhold for Grade 3 or 4; once returned to Grade 1 or below resume at 100 mg twice daily, re-escalating to 150 mg twice daily if it does not recur. NEUTROPENIA: ANC 1,000 to less than 1,500/mm3 — maintain dosing; ANC 500 to less than 1,000/mm3 — maintain dosing and monitor ANC at least weekly; ANC less than 500/mm3 — interrupt dosing and monitor ANC at least weekly until ANC is 500/mm3 or above, then may resume at 100 mg twice daily. ELDERLY: no specific dose adjustment for patients aged 65 years or over. HEPATIC IMPAIRMENT: no dose adjustment when initiating in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment, but intensified monitoring for adverse reactions is recommended; there is insufficient data to make dose recommendations in severe hepatic impairment, so caution and intensified monitoring are recommended. PAEDIATRIC: safety and efficacy in children under 18 years have not been established and no data are available — verify against a children's formulary. INTERACTIONS PROVENANCE: no section 4.5 was captured in the fetched UK SPC extract, so the interactions listed below are distilled from section 7 of the US prescribing information and should be checked against the UK SPC.