Copiktra(Duvelisi Capsules)
COPIKTRA Rx
Generic Name and Formulations:
Duvelisib 15mg, 25mg; caps.
Company:
Verastem Oncology
Indications for COPIKTRA:
Treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. Treatment of adults with relapsed or refractory follicular lymphoma (FL) after at least 2 systemic therapies.
Adult:
Swallow whole. 25mg twice daily in a 28-day cycle. Give PJP prophylaxis during and after completing Copiktra treatment until absolute CD4+ T cell count >200 cells/µL. Concomitant strong CYP3A4 inhibitors (eg, ketoconazole): reduce to 15mg twice daily. Dose modifications: see full labeling.
Children:
Not established.
Boxed Warning:
Fatal and serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.
Warnings/Precautions:
Risk of serious infections (eg, pneumonia, sepsis, lower respiratory); treat prior to initiation. Monitor for new or worsening signs/symptoms of infection; withhold if Grade ≥3 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. Monitor for new or worsening diarrhea or colitis; if presented, initiate supportive care as appropriate (see full labeling) and monitor at least weekly until resolved; discontinue if life-threatening diarrhea or colitis occurs. Monitor for new or worsening cutaneous reactions; if presented, initiate supportive care as appropriate (see full labeling) and monitor at least weekly until resolved; discontinue if life-threatening reaction occurs 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 is 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. Females of reproductive potential and males (w. female partners): 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).
Pharmacological Class:
Phosphoinositide 3-kinase (PI3K) inhibitor.
Interactions:
Antagonized by strong CYP3A4 inducers; avoid. Potentiated by strong CYP3A4 inhibitors; reduce dose (see Adults). Potentiates sensitive CYP3A4 substrates; consider reducing dose of these and monitor for toxicities.
Adverse Reactions:
Diarrhea, colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory tract infection, pneumonia, musculoskeletal pain, anemia.
REMS:
YES
Generic Availability:
NO
How Supplied:
Caps—56 |
