• Leukemias, lymphomas, and other hematologic cancers

Copiktra Generic Name & Formulations

General Description

Duvelisib 15mg, 25mg; caps.

Pharmacological Class

Phosphoinositide 3-kinase (PI3K) inhibitor.

How Supplied

Caps—28, 56


Generic Availability


Copiktra Indications


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.


Not established.

Copiktra Contraindications

Not Applicable

Copiktra Boxed Warnings

Boxed Warning

Fatal and serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.

Copiktra Warnings/Precautions


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).



Copiktra Pharmacokinetics

See Literature

Copiktra Interactions


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

Adverse Reactions

Diarrhea, colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory tract infection, pneumonia, musculoskeletal pain, anemia.

Copiktra Clinical Trials

See Literature

Copiktra Note

Not Applicable

Copiktra Patient Counseling

See Literature