Leukemias, lymphomas, and other hematologic cancers:
Indications for: ALIQOPA
In adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Adult Dosage:
Give as IV infusion over 1hr. 60mg on Days 1, 8, and 15 of a 28-day cycle on an intermittent schedule (3 weeks on, 1 week off). Continue until disease progression or unacceptable toxicity. Moderate hepatic impairment (Child-Pugh B), concomitant strong CYP3A inhibitors: reduce to 45mg. Severe hepatic impairment (Child-Pugh C): reduce to 30mg. Dose modifications for toxicities: see full labeling.
Children Dosage:
Not established.
ALIQOPA Warnings/Precautions:
Monitor for 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 post-dose BP remains uncontrolled (>150/90mmHg) despite antihypertensives or elevated with life-threatening consequences. Monitor blood counts at least weekly during therapy. Monitor for non-infectious pneumonitis, neutropenia, severe cutaneous reactions, thrombocytopenia, other severe and non-life-threatening toxicities; see full labeling. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use highly effective contraception during treatment and for ≥1 month after the last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥1 month after the last dose).
ALIQOPA Classification:
Kinase inhibitor.
ALIQOPA Interactions:
May be antagonized by strong CYP3A inducers (eg, rifampin, St. John’s wort); avoid. Potentiated by strong CYP3A inhibitors (eg, itraconazole, grapefruit juice); if concomitant use unavoidable, reduce Copanlisib dose (see Adult).
Adverse Reactions:
Hyperglycemia, diarrhea, decreased general strength/energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, thrombocytopenia.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
