Duvelisib Disease Interactions

Serious, including fatal diarrhea or colitis has been reported in 18% of patients receiving treatment with duvelisib. Patients with history of colitis should be monitored closely for any signs or symptoms. Advise patients to report any new or worsening diarrhea. Patients presenting with abdominal pain, stool with mucus or blood, change in bowel habits, peritoneal signs, or with diarrhea that is noninfectious should be followed closely and supportive therapy should be initiated based on severity (antidiarrheal agents, to enteric acting or systemic steroids if needed). A diagnostic work- up to determine etiology, including colonoscopy, should be performed. Monitor at least weekly. Upon resolution of the diarrhea or colitis, treatment can be restarted at a reduced dose. Treatment should be discontinued for recurrent Grade 3 diarrhea or recurrent colitis of any grade.

Any infection should be treated prior to initiation of treatment with duvelisib. Serious, including fatal infections have occurred in patients receiving treatment with this drug. The most common serious infections were pneumonia (including fatal pneumocystis jirovecii pneumonia, PJP), sepsis, and lower respiratory infections. Advise patients to report any new or worsening signs and symptoms of infection. In some cases, treatment might need to be suspended while the infection is treated. Prophylaxis for PJP should be provided during treatment, and in some cases also prophylactic antivirals should be considered in patients with history of CMV infection to avoid CMV reactivation.

Bilirubin and ALT and/or AST elevation has been reported in patients receiving duvelisib. Monitor hepatic function in all patients during treatment with duvelisib. Caution and close monitoring is advised in patients with hepatic impairment.

Caution and close monitoring is advised when starting treatment in patients with neutropenia. Grade 3 or 4 neutropenia has been reported in 42% of patients receiving treatment. Monitor neutrophil counts at least every 2 weeks for the first 2 months of duvelisib therapy, and at least weekly in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4). Withhold treatment with duvelisib in patients presenting with neutrophil counts < 0.5 Gi/L (Grade 4). Monitor until ANC is > 0.5 Gi/L, and then resume duvelisib at same dose for the first occurrence or a reduced dose for subsequent occurrence.