Active Ingredient: Idelalisib
Idelalisib is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
For this indication, competent medicine agencies globally authorize below treatments:
Oral
300 - 300 mg
From 150 To 150 mg 2 time(s) per day every day
The recommended dose is 150 mg idelalisib twice daily. Treatment should be continued until disease progression or unacceptable toxicity.
If the patient misses a dose of idelalisib within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Treatment with idelalisib must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] >5 x upper limit of normal [ULN]). Once values have returned to Grade 1 or below (ALT/AST ≤3 x ULN), treatment can be resumed at 100 mg twice daily.
If the event does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
If the event recurs, treatment with idelalisib must be withheld until the values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered at the discretion of the physician.
Treatment with idelalisib must be withheld in the event of Grade 3 or 4 diarrhoea/colitis. Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily. If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
Treatment with idelalisib must be withheld in the event of suspected pneumonitis. Once pneumonitis has resolved and if re-treatment is appropriate, resumption of treatment at 100 mg twice daily can be considered. Treatment with idelalisib must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia.
Treatment with idelalisib must be withheld in the event of Grade 3 or 4 rash. Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily. If rash does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
Treatment with idelalisib should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm³. ANC should be monitored at least weekly until ANC is ≥500 per mm³ when treatment can be resumed at 100 mg twice daily.
| ANC 1,000 to <1,500/mm³ | ANC 500 to <1,000/mm³ | ANC <500/mm³ |
|---|---|---|
| Maintain idelalisib dosing. | Maintain idelalisib dosing. Monitor ANC at least weekly. | |
| Interrupt idelalisib dosing. Monitor ANC at least weekly until ANC ≥500/mm³, then may resume idelalisib dosing at 100 mg twice daily. |
It can be taken with or without food.
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