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Information about Copanlisib

Copanlisib is an intravenously administered phosphatidylinositol-3 kinase inhibitor that is used to treat relapsed and refractory follicular lymphoma.  


Liver safety of Copanlisib

Copanlisib is associated with a high rate of minor serum enzyme elevations during therapy and has been reported to cause clinically apparent acute liver injury that can be severe and even fatal. 

Mechanism of action of Copanlisib

Copanlisib (koe" pan lis' ib) is an intravenously administered small molecule inhibitor of phosphatidylinositol 3-kinase (PI3K) alpha and delta which are essential components in B cell signaling pathways that drive survival of B cells and their migration to lymph nodes and bone marrow.  Inhibition of this pathway inhibits B cell chemotaxis and adherence and reduces cell viability.  This pathway is upregulated in many B cell malignancies and is known to be critical for proliferation and survival of leukemia and lymphomatous malignant B lymphocytes. 

FDA approval information for Copanlisib

Copanlisib has been shown to result in high rates of objective response in patients with refractory or relapsed follicular lymphoma and was given accelerated approval for this use in the United States in 2017. 

Dosage and administration for Copanlisib

Copanlisib is available in as lyophilized powder in 60 mg single dose vials under the brand name Aliqopa.  The recommended dose is 60 mg given as an intravenous infusion on days 1, 8 and 15 of 28-day cycles. 

Side effects of Copanlisib

Side effects are common but usually mild-to-moderate in severity, and include nausea, diarrhea, headache, stomatitis, fever, pain, rash, infections, arthralgia and fatigue.  Common laboratory abnormalities can include hyperglycemia and cytopenias.  Severe adverse events can include marked hypertension, severe diarrhea, neutropenia, infectious and non-infectious pneumonitis, severe cutaneous reactions and embryo-fetal toxicity.

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