Mobocertinib Disease Interactions

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 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.

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 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.

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.