Datroway Disease Interactions

The recommended dosage of datopotamab deruxtecan has not been established for patients with severe liver dysfunction (total bilirubin greater than 3 times the upper limit of normal [3 x ULN] and any AST). Limited data are available in patients with moderate liver dysfunction (total bilirubin greater than 1.5 to 3 x ULN and any AST); these patients should be monitored for increased adverse reactions. No dosage adjustment is recommended in patients with mild liver dysfunction (total bilirubin up to 1 x ULN and AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN and any AST).

Datopotamab deruxtecan can cause ocular adverse reactions (including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision). The clinical trial excluded patients with clinically significant corneal disease. Patients should be referred promptly to an eye care professional for any new or worsening ocular adverse reactions. Patients should be advised to avoid using contact lenses unless directed by an eye care professional.

Datopotamab deruxtecan can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. The clinical trial excluded patients with history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis. Patients should be monitored for new or worsening respiratory symptoms indicative of ILD/pneumonitis during treatment with datopotamab deruxtecan.

The effect of severe renal dysfunction (CrCl less than 30 mL/min) on the pharmacokinetics of datopotamab deruxtecan is unknown. No dosage adjustment is recommended in patients with mild to moderate renal dysfunction (CrCl 30 to less than 90 mL/min); a higher incidence of interstitial lung disease/pneumonitis has been observed in these patients. Patients with renal dysfunction should be monitored for increased adverse reactions (including respiratory reactions).