Tivdak

Risk of ocular toxicity. Conduct eye exam at baseline, prior to each dose, and as indicated. Adhere to premedication and required eye care (eg, lubricating eye drops, contact lenses) before, during, and after infusion; see full labeling. Monitor for new or worsening ocular symptoms (eg, keratitis, conjunctival ulceration, conjunctival/corneal scarring, symblepharon, conjunctivitis, others), peripheral neuropathy. Withhold therapy until improvement and resume, reduce the dose, or permanently discontinue based on the severity of the adverse reaction. Monitor for hemorrhage; withhold dose if Grade ≥2 severity in any other location; permanently discontinue if pulmonary or CNS hemorrhage, or Grade 4 in any other location. Monitor for pneumonitis; withhold if persistent/recurrent Grade 2 severity and consider dose reduction; permanently discontinue if Grade 3 or 4. Monitor for severe cutaneous adverse reactions; withhold if occurs until the etiology is determined; permanently discontinue for confirmed Grade 3 or 4. Hepatic impairment (moderate or severe): avoid; (mild): monitor closely. Embryo-fetal toxicity. Advise to use effective contraception during and for 2 months (females of reproductive potential) and for 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 weeks after the last dose).