Leukemias, lymphomas, and other hematologic cancers:

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).

Pharmacologic 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

Pricing for COPIKTRA

56 capsules of 25mg package (Qty: 1)
Appx. price $12879
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