• Monitor for signs and symptoms of infection (fever, chills) during therapy. If ≥Grade 3 infections occur, hold duvelisib until infection resolved. Resume as same or ↓ dose. If clinical cytomegalovirus (CMV) infection or viremia (positive PCR or antigen test) occurs, hold duvelisib until resolved. Resume at same or ↓ dose. If resumed, monitor patient for CMV reactions (by PCR or antigen test) at least monthly. If

  Pneumocystis jirovecii

  pneumonia (PJP) occurs, hold duvelisib until infections evaluated. If PJP confirmed, discontinue duvelisib.
• Monitor for new or worsening noninfectious diarrhea or colitis. For mild/moderate diarrhea (Grade 1–2, up to 6 stools per day over baseline) and responsive to antidiarrheal agents, OR asymptomatic (Grade 1) colitis, continue duvelisib at same dose. Initiate antidiarrheal agents and monitor weekly until resolved. For mild/moderate diarrhea (Grade 1–2, up to 6 stools per day over baseline) and unresponsive to antidiarrheal agents, hold duvelisib until resolved. Start enteric-acting steroids (budesonide). Monitor weekly until resolved. Resume duvelisib at ↓ dose. If abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, OR severe diarrhea (Grade 3, >6 stools per day over baseline) occurs, hold duvelisib until resolved. Start enteric-acting steroids or systemic steroids. Monitor weekly until resolved. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue duvelisib. If life-threatening diarrhea occurs, discontinue duvelisib.
• Monitor for signs and symptoms of skin reactions (pruritic, erythematous, maculopapular) during therapy. For Grade 1–2 skin reactions, continue duvelisib dose. Begin therapy with emollients, antihistamines (for pruritus), or topical steroids. Monitor closely. For Grade 3 skin reactions, hold duvelisib until resolved. Begin therapy with emollients, antihistamines (for pruritus), or topical steroids. Monitor at least weekly until resolved. Resume duvelisib at ↓ dose. If skin reaction does not improve, worsens, or recurs, discontinue duvelisib. If life-threatening skin reactions, SJS, TEN, or DRESS occur, discontinue duvelisib.
• Monitor for signs and symptoms of noninfectious pneumonitis (new or progressive cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic exam, ↓ by >5% in oxygen saturation) during therapy. For moderate (Grade 2) symptoms, hold duvelisib. Treat with systemic steroids. If recovery to Grade 0–1, resume duvelisib at ↓ dose. If noninfectious pneumonitis recurs or no response to steroid therapy, discontinue duvelisib. For severe (Grade 3) or life-threatening pneumonitis, discontinue duvelisib and treat with systemic steroids.

Lab Test Considerations:

• Verify negative pregnancy test before starting therapy.
  • Monitor hepatic function during therapy. If AST/ALT ↑ to 3–5 times upper limit of normal (ULN) (Grade 2), continue duvelisib dose. Monitor AST and ALT at least weekly until return to <3 × ULN. If AST/ALT ↑ to 5–20 × ULN (Grade 3), hold duvelisib and monitor AST and ALT at least weekly until return to <3 × ULN. Resume duvelisib at same dose for 1st occurrence or ↓ dose for subsequent occurrences. If AST/ALT ↑ to >20 × ULN (Grade 4), discontinue duvelisib.
  • Monitor neutrophil counts at least every 2 wk for first 2 mo of therapy and at least weekly in patients with Grade 3 or 4 neutrophil counts. If ANC 0.5–1 mm³/L, continue duvelisib dose. Monitor ANC at least weekly. If ANC <0.5 mm³/L, hold duvelisib. Monitor ANC until >0.5 mm³/L. Resume duvelisib at same dose for 1st occurrence or ↓ dose for subsequent recurrence.
  • Monitor platelet count during therapy. If platelet count 25–<50 mm³/L (Grade 3) with Grade 1 bleeding, continue duvelisib dose. Monitor platelet counts at least weekly. If platelet count 25–<50 mm³/L (Grade 3) with Grade 2 bleeding or platelet count <25 mm³/L (Grade 4), hold duvelisib. Monitor platelet counts until ≤25 mm³/L and bleeding resolves. Resume duvelisib at same dose for 1st occurrence or reduced dose for subsequent recurrence.