COPIKTRA Rx

Risk of serious infections (eg, pneumonia, sepsis, lower respiratory); treat prior to initiation. Withhold if Grade ≥3 infection until resolved; resume at same or lower dose. Withhold if any grade of Pneumocystis jirovecii pneumonia (PJP) suspected; permanently discontinue if confirmed. Consider antiviral prophylaxis for CMV infection/reactivation during therapy. Non-infectious diarrhea or colitis: initiate supportive care as appropriate if occurs (see full labeling); monitor at least weekly until resolved; discontinue if life-threatening diarrhea or colitis occurs. Cutaneous reactions: initiate supportive care as appropriate if occurs (see full labeling); monitor at least weekly until resolved; discontinue if life-threatening or if severe reaction does not improve, worsens, or recurs. Withhold if new or progressive pulmonary signs/symptoms develop; discontinue if severe/life-threatening or if non-infectious pneumonitis recurs or unresponsive to steroids. Monitor hepatic function during treatment; withhold and monitor at least weekly if Grade 3 ALT/AST elevation (>5–20×ULN) until return to <3×ULN; discontinue if Grade 4 ALT/AST elevation (>20×ULN). Monitor neutrophil counts at least every 2 weeks for the first 2 months and at least weekly if counts <1.0Gi/L; withhold if <0.5Gi/L; monitor until ANC >0.5Gi/L. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for at least 1 month after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 1 month after last dose).