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Aliqopa(Copanlisib for Injection, for Intravenous Use)
Aliqopa(Copanlisib for Injection, for Intravenous Use)
ALIQOPA
Leukemias, lymphomas, and other hematologic cancers Only 4 drugs may be compared at once
Generic Name and Formulations:
Copanlisib 60mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Company:
Bayer Healthcare Pharmaceuticals Inc
Select therapeutic use:
RECENT UPDATES Monograph added.
Indications for ALIQOPA:
Treatment of adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Adult:
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.
Children:
Not established.
Warnings/Precautions:
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).
Interactions:
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).
Pharmacological Class:
Kinase inhibitor.
Adverse Reactions:
Hyperglycemica, diarrhea, decreased general strength/energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, thrombocytopenia.
Generic Availability:
NO
How Supplied:
Single-dose vial—1 |
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