Copanlisib

The Basics

What is Copanlisib?

Treats follicular lymphoma that has come back after treatment with at least two previous medicines did not work as well.

Brand names for Copanlisib

Aliqopa

How Copanlisib is classified

Antineoplastic Agents, Enzyme Inhibitors, Signal Transduction Inhibitors

Copanlisib During Pregnancy

Copanlisib pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Copanlisib while pregnant

Based on findings from animal studies and the mechanism of action, ALIQOPA can cause fetal harm whenadministered to a pregnant woman [see Clinical Pharmacology (12.1)].There are no available data in pregnant women to inform the drug-associated risk. In animal reproductionstudies, administration of copanlisib to pregnant rats during organogenesis resulted in embryo-fetal deathand fetal abnormalities at maternal doses approximately 12% of the recommended dose for patients (seeData). Advise pregnant women of the potential risk to a fetus.Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. Thebackground risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S.general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2% to 4% and 15% to 20%, respectively.DataAnimal DataIn an embryo-fetal development study in rats, pregnant animals received intravenous doses of copanlisib of0, 0.75, or 3 mg/kg/day during the period of organogenesis. Administration of copanlisib at the dose of 3mg/kg/day resulted in maternal toxicity and no live fetuses. Copanlisib administration at the dose of 0.75mg/kg/day was maternally toxic and resulted in embryo-fetal death (increased resorptions, increased postimplantation loss, and decreased numbers of fetuses/dam). The dose of 0.75 mg/kg/day also resulted inincreased incidence of fetal gross external (domed head, malformed eyeballs or eyeholes), soft tissue(hydrocephalus internus, ventricular septal defects, major vessel malformations), and skeletal (dysplasticforelimb bones, malformed ribs and vertebrae, and pelvis shift) abnormalities. The dose of 0.75 mg/kg/day(4.5 mg/m2 body surface area) in rats is approximately 12% of the recommended dose for patients.Following administration of radiolabeled copanlisib to pregnant rats approximately 1.5% of the radioactivity(copanlisib and metabolites) reached the fetal compartment.

Taking Copanlisib While Breastfeeding

What are recommendations for lactation if you're taking Copanlisib?

No information is available on the clinical use of copanlisib during breastfeeding. Because copanlisib’s half-life is about 39 hours, it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during copanlisib therapy and for 1 month after the last dose.

Maternal / infant drug levels

No information is available on the clinical use of copanlisib during breastfeeding. Because copanlisib’s half-life is about 39 hours, it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during copanlisib therapy and for 1 month after the last dose.

Possible effects of Copanlisib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Copanlisib

None listed