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Zydelig
idelalisib
Black Box Warnings .
Hepatotoxicity
serious or fatal cases occurred in 16% of pts; monitor LFTs before and during tx; interrupt tx and reduce dose if ALT or AST >5-20x ULN or bilirubin >3-10x ULN; D/C tx if ALT or AST >20x ULN or bilirubin >10x ULN
Severe Diarrhea or Colitis
serious or fatal cases occurred in 20% of pts; monitor for severe diarrhea or colitis; interrupt tx and reduce dose if severe diarrhea or hospitalization occurs; D/C tx if life-threatening diarrhea occurs
Pneumonitis
serious or fatal cases occurred in 4% of pts; monitor for pulmonary sx and bilateral interstitial infiltrates; D/C tx if any severity of symptomatic pneumonitis occurs
Serious Infections
serious or fatal cases occurred in 48% of pts; monitor for infection s/sx; interrupt tx if grade 3 or 4 infection, incl. sepsis and pneumonia, CMV, or PCP occurs; give PCP prophylaxis during tx
Intestinal Perforation
serious or fatal cases can occur; D/C tx if intestinal perforation occurs
Adult Dosing .
Dosage forms: TAB: 100 mg, 150 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
CLL, relapsed
- [150 mg PO bid]
- Info: use w/ rituximab
SLL, relapsed (off-label)
- [150 mg PO bid]
- Info: use w/ or w/o rituximab
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.