ZYDELIG Rx

Hepatotoxicity: monitor ALT/AST every 2 weeks for the first 3 months, every 4 weeks for the next 3 months, then every 1–3 months thereafter; if ALT/AST >3×ULN, monitor weekly until resolved; if ALT/AST >5×ULN, withhold and continue monitoring weekly until resolved; if ALT/AST >20×ULN or bilirubin >10×ULN, discontinue permanently. Monitor for diarrhea or colitis; withhold if severe or hospitalization; discontinue permanently if life-threatening. Pneumonitis: monitor for pulmonary symptoms or a decline by >5% in oxygen saturation; if diagnosed, treat and discontinue permanently. Infections: monitor and interrupt if Grade ≥3. Treat infections before starting. Provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis during treatment; interrupt if PJP infection is suspected and permanently discontinue if confirmed. Monitor patients with history of CMV infection or (+) baseline CMV serology; interrupt if CMV PCR (+) until resolved; if resumed, monitor for reactivation at least monthly. Discontinue permanently if intestinal perforation occurs. Monitor for severe cutaneous (eg, SJS, TEN, DRESS) or serious hypersensitivity reactions; permanently discontinue if occur. Monitor CBCs at least every 2 weeks for the first 6 months, and at least weekly if neutrophils <1.0Gi/L. Hepatic impairment: monitor. Embryo-fetal toxicity. Advise to use effective contraception during and for at least 1 month (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).