Copiktra Generic Name & Formulations
Duvelisib 15mg, 25mg; caps.
Phosphoinositide 3-kinase (PI3K) inhibitor.
In adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies.
Copiktra Dosage and Administration
Swallow whole. 25mg twice daily in a 28-day cycle. Give PJP prophylaxis during and after Copiktra treatment until absolute CD4+ T cell count >200 cells/µL. Concomitant strong CYP3A4 inhibitors (eg, ketoconazole): reduce to 15mg twice daily. Concomitant strong or moderate CYP3A4 inducers, dose modifications for adverse reactions: see full labeling.
Copiktra Boxed Warnings
Fatal and serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.
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).
Potentiated by strong CYP3A4 inhibitors; reduce dose. Antagonized by strong or moderate CYP3A4 inducers; avoid. If concomitant moderate CYP3A4 inducers unavoidable, increase duvelisib dose. Potentiates sensitive CYP3A4 substrates; consider reducing dose of these and monitor for toxicities.
Copiktra Adverse Reactions
Diarrhea, colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory tract infection, pneumonia, musculoskeletal pain, anemia.
Copiktra Clinical Trials
Copiktra Patient Counseling