Interactions between Duvelisib and Mobocertinib

Mobocertinib has a moderate potential interaction with Cardiomyopathy.

Mobocertinib can cause cardiac toxicity (including decreased ejection fraction, cardiomyopathy, and congestive heart failure) resulting in heart failure which can be fatal. Cardiac function (including assessment of left ventricular ejection fraction) should be monitored at baseline and during therapy. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of decreased ejection fraction or heart failure.

Mobocertinib has a major potential interaction with Electrolyte Abnormalities.

Mobocertinib can cause life-threatening QTc prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes. QTc and electrolytes should be assessed at baseline and abnormalities in sodium, potassium, calcium, and magnesium should be corrected before starting mobocertinib. QTc and electrolytes should be monitored periodically during therapy. Monitoring frequency should be increased in patients with risk factors for QTc prolongation (such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities); caution is recommended in these patients. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of QTc prolongation.

Mobocertinib has a major potential interaction with Heart Disease.

Mobocertinib can cause life-threatening QTc prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes. QTc and electrolytes should be assessed at baseline and abnormalities in sodium, potassium, calcium, and magnesium should be corrected before starting mobocertinib. QTc and electrolytes should be monitored periodically during therapy. Monitoring frequency should be increased in patients with risk factors for QTc prolongation (such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities); caution is recommended in these patients. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of QTc prolongation.

Mobocertinib has a moderate potential interaction with Heart Failure.

Mobocertinib can cause cardiac toxicity (including decreased ejection fraction, cardiomyopathy, and congestive heart failure) resulting in heart failure which can be fatal. Cardiac function (including assessment of left ventricular ejection fraction) should be monitored at baseline and during therapy. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of decreased ejection fraction or heart failure.

Mobocertinib has a major potential interaction with Hypocalcemia.

Mobocertinib can cause life-threatening QTc prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes. QTc and electrolytes should be assessed at baseline and abnormalities in sodium, potassium, calcium, and magnesium should be corrected before starting mobocertinib. QTc and electrolytes should be monitored periodically during therapy. Monitoring frequency should be increased in patients with risk factors for QTc prolongation (such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities); caution is recommended in these patients. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of QTc prolongation.

Mobocertinib has a major potential interaction with Hypokalemia.

Mobocertinib can cause life-threatening QTc prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes. QTc and electrolytes should be assessed at baseline and abnormalities in sodium, potassium, calcium, and magnesium should be corrected before starting mobocertinib. QTc and electrolytes should be monitored periodically during therapy. Monitoring frequency should be increased in patients with risk factors for QTc prolongation (such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities); caution is recommended in these patients. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of QTc prolongation.

Mobocertinib has a major potential interaction with Hyponatremia.

Mobocertinib can cause life-threatening QTc prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes. QTc and electrolytes should be assessed at baseline and abnormalities in sodium, potassium, calcium, and magnesium should be corrected before starting mobocertinib. QTc and electrolytes should be monitored periodically during therapy. Monitoring frequency should be increased in patients with risk factors for QTc prolongation (such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities); caution is recommended in these patients. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of QTc prolongation.

Duvelisib has a major potential interaction with Infection.

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.

Duvelisib has a moderate potential interaction with Liver Disease.

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.

Mobocertinib has a moderate potential interaction with Liver Disease.

No dosage adjustment of mobocertinib is recommended for patients with mild (total bilirubin up to the upper limit of normal [ULN] and AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN [1 to 1.5 x ULN] and any AST) or moderate (total bilirubin 1.5 to 3 x ULN and any AST) liver dysfunction. The recommended dosage of mobocertinib has not been established for patients with severe liver dysfunction (total bilirubin greater than 3 times ULN and any AST); caution is recommended in these patients.

Mobocertinib has a major potential interaction with Magnesium Imbalance.

Mobocertinib can cause life-threatening QTc prolongation, including torsades de pointes, which can be fatal, and requires monitoring of QTc and electrolytes. QTc and electrolytes should be assessed at baseline and abnormalities in sodium, potassium, calcium, and magnesium should be corrected before starting mobocertinib. QTc and electrolytes should be monitored periodically during therapy. Monitoring frequency should be increased in patients with risk factors for QTc prolongation (such as patients with congenital long QT syndrome, heart disease, or electrolyte abnormalities); caution is recommended in these patients. Therapy should be withheld, the dose should be reduced, or mobocertinib should be discontinued based on the severity of QTc prolongation.

Duvelisib has a moderate potential interaction with Neutropenia.

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.

Duvelisib has a major potential interaction with Noninfectious Colitis.

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.

Mobocertinib has a moderate potential interaction with Pulmonary Impairment.

Mobocertinib can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal. Care should be exercised when using this drug in patients with preexisting pulmonary impairment. Mobocertinib should be immediately withheld in patients with suspected ILD/pneumonitis and permanently discontinued if ILD/pneumonitis is confirmed. Patients should be monitored for new/worsening pulmonary symptoms indicative of ILD/pneumonitis.

Mobocertinib has a moderate potential interaction with Renal Dysfunction.

No dosage adjustment of mobocertinib is recommended for patients with mild to moderate renal dysfunction (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73 m2 by Modification of Diet in Renal Disease equation). The recommended dosage of mobocertinib has not been established for patients with severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2); caution is recommended in these patients.