Ensartinib Disease Interactions

Ensartinib contains FD&C Yellow 5 (tartrazine) and may cause allergic-type reactions, including bronchial asthma, in susceptible persons. These reactions are frequently seen in patients who also have hypersensitivity to aspirin. This drug is contraindicated in persons who experienced previous hypersensitivity reactions to the active ingredient or any of the excipients.

Ensartinib should be avoided in patients with severe liver dysfunction (total bilirubin greater than 3 x ULN and any AST). Monitor patients with moderate liver dysfunction (total bilirubin greater than 1.5 to 3 x ULN and any AST) for increased adverse reactions and adjust dosage as indicated. No dose adjustment is recommended in patients with mild liver dysfunction. Additionally, ensartinib may cause hepatotoxicity, including drug-induced liver injury. Monitor liver function tests including ALT, AST, and total bilirubin at baseline and every 2 weeks during the first treatment cycle, and then monthly or as indicated.

Ensartinib can cause severe interstitial lung disease (ILD)/pneumonitis. Monitor patients on ensartinib for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever) during treatment. Immediately withhold therapy in patients with suspected ILD/pneumonitis; permanently discontinue if confirmed.

The effect of severe renal dysfunction or end-stage renal disease (with or without hemodialysis) on the pharmacokinetics (PK) of ensartinib is unknown. No clinically significant PK differences were observed based on mild or moderate renal dysfunction.

Ensartinib can cause visual disturbances. Obtain an ophthalmologic evaluation in patients with new or worsening visual symptoms during treatment. Withhold, reduce the dose, or permanently discontinue based on severity visual adverse effects.