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Aliqopa Generic Name & Formulations
Legal Class
Rx
General Description
Copanlisib 60mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Kinase inhibitor.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Aliqopa Indications
Indications
In adults with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
Aliqopa Dosage and Administration
Adult
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
Not established.
Aliqopa Contraindications
Not Applicable
Aliqopa Boxed Warnings
Not Applicable
Aliqopa Warnings/Precautions
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 Pharmacokinetics
See Literature
Aliqopa Interactions
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).
Aliqopa Adverse Reactions
Adverse Reactions
Hyperglycemia, diarrhea, decreased general strength/energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, thrombocytopenia.
Aliqopa Clinical Trials
See Literature
Aliqopa Note
Not Applicable
Aliqopa Patient Counseling
See Literature
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