Calquence Disease Interactions

Atrial fibrillation and atrial flutter have been observed in patients treated with acalabrutinib. It is recommended to monitor patients with abnormal heart rhythm for atrial fibrillation and atrial flutter and manage as clinically appropriate.

Serious hemorrhagic events, including fatal events, have occurred in patients treated with acalabrutinib. Care should be exercised when using acalabrutinib in patients with bleeding disorders. It is recommended to monitor for signs of bleeding and to consider the benefit-risk of withholding therapy for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Acalabrutinib is metabolized in the liver. Based on the population pharmacokinetic analysis, no clinically relevant difference was observed in subjects with mild or moderate hepatic impairment. The pharmacokinetic of acalabrutinib has not been evaluated in patients with severe hepatic impairment. Close monitoring of liver function is recommended in these patients.

Serious infections (bacterial, viral or fungal), including fatal events and opportunistic infections have occurred in patients treated with acalabrutinib. Care should be exercised in patients at risk as in those at increased susceptibility to infection, such as neutropenic patients or those with a prior history of hepatitis B virus infection. It is recommended to monitor patients for signs and symptoms of infection and treat as medically appropriate. Consider prophylaxis in patients who are at increased risk for opportunistic infections.

Acalabrutinib undergoes minimal renal elimination. Based on the population pharmacokinetic analysis, no clinically relevant difference was observed in patients with mild or moderate renal impairment. The pharmacokinetic of acalabrutinib has not been evaluated in patients with severe renal impairment or renal impairment requiring dialysis. Close monitoring of renal function is recommended in these patients.