Generic Name and Formulations:
Copanlisib 60mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Indications for ALIQOPA:
Treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Give 60mg as IV infusion over 1hr on Days 1, 8, and 15 of a 28-day cycle on an intermittent schedule (3 weeks on, 1 week off) until disease progression or unacceptable toxicity. Concomitant strong CYP3A inhibitors: reduce to 45mg. Dose modifications for toxicities: see full labeling.
Monitor for signs/symptoms of infection (eg, pneumonia); withhold if Grade ≥3 infection develops. Risk of serious pneumocystis jiroveci pneumonia (PJP); consider PJP prophylaxis for those at risks prior to initiation. Diabetes. Obtain optimal blood glucose and blood pressure (BP) control prior to each infusion; monitor closely. Discontinue if blood glucose ≥500mg/dL is persistent at Copanlisib 30mg dose. Discontinue if post-dose BP remains uncontrolled (>150/90mmHg) despite antihypertensives or elevated with life-threatening consequences. Withhold and treat if non-infectious pneumonitis occurs; discontinue if Grade 2 recurs or if Grade ≥3 develops. Monitor ANC at least weekly; withhold if ANC <0.5 x 103 cells/mm3; reduce to 45mg if ANC ≤0.5 x 103 cells/mm3 recurs. Monitor for severe cutaneous reactions; withhold for Grade 3 reaction; discontinue if life-threatening. Monitor for thrombocytopenia, other severe and non-life-threatening toxicities; see full labeling. Embryo-fetal toxicity. Females of reproductive potential and males (w. female partners) should use highly effective contraception during treatment and for ≥1 month after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 month after last dose).
May be antagonized by strong CYP3A inducers (eg, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort); avoid. Potentiated by strong CYP3A inhibitors (eg, boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir/ritonavir, diltiazem, elvitegravir/ritonavir, grapefruit juice, idelalisib, indinavir/ritonavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, paritaprevir/ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir/ritonavir, tipranavir/ritonavir, troleandomycin, voriconazole); if concomitant use unavoidable, reduce Copanlisib dose (see Adult).
Hyperglycemica, diarrhea, decreased general strength/energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, thrombocytopenia.