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copanlisib (Aliqopa)

Indications: - relapsed follicular lymphoma with >= 2 prior systemic therapies Contraindications: - pregnancy Dosage: - 60 mg IV infusion over 1 hour on days 1, 8, & 15 of a 28-day treatment cycle - continue until disease progression or unacceptable toxicity 60 mg lyophilized in single-dose vial for reconstitution Pharmacokinetics: - metabolized by CYP3A Adverse effects: - hyperglycemia - hypertension - pneumonitis - neutropenia - skin reactions - may induce fetal abnormalities Drug interactions: - avoid concurrent use of strong CYP3A inducers - reduce dose to 45 mg with concurrent use of strong CYP3A inhibitors Mechanism of action: - phosphatidylinositol-3-kinase inhibitor - inhibits primarily PIK3CA & PIK3CD

General

small inhibitory antineoplastic agent (ib drug) protein kinase inhibitor

Database Correlations

PUBCHEM correlations

References

  1. Gever J, MedPage Today. September 14, 2017 Novel Kinase Inhibitor OK'd for Follicular Lymphoma. Copanlisib (Aliqopa) approved as third-line therapy. https://www.medpagetoday.com/HematologyOncology/Lymphoma/67913 - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  2. Dreyling M et al. Copanlisib in patients with relapsed or refractory indolent B-cell lymphoma: primary results of the pivotal CHRONOS-1 study. Hematology Oncology. June 7, 2017.
  3. Dreyling M, Morschhauser F, Bouabdallah K et al Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. PMID: 28633365
  4. Dreyling M, Santoro A, Mollica L et al Phosphatidylinositol 3-Kinase Inhibition by Copanlisib in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2017 Dec 10;35(35):3898-3905. Epub 2017 Oct 4. PMID: 28976790
  5. ALIQOPA. HIGHLIGHTS OF PRESCRIBING INFORMATION https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf