Examplesa of strong CYP3A inducers include: carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wortb.

 

Strong CYP3A Inhibitors 

 

Concomitant use of ALIQOPA with strong CYP3A inhibitors increases the copanlisib AUC. If concomitant use with strong CYP3A inhibitors cannot be avoided, reduce the ALIQOPA dose to 45 mg. An increase in the copanlisib AUC may increase the risk of adverse reactions [see Clinical Pharmacology (12.3)]. 

 

Examplesa of strong CYP3A inhibitors include: boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juicec, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, tipranavir and ritonavir, troleandomycin, voriconazole. 

 

aThese examples are a guide and not considered a comprehensive list of all possible drugs that may fit this category. The healthcare provider should consult appropriate references for comprehensive information. 

 

bThe induction potency of St. John’s wort may vary widely based on preparation.

 

cThe effect of grapefruit juice varies widely among brands and is concentration-, dose-, and preparation-dependent. Studies have shown that it can be classified as a “strong CYP3A inhibitor” when a certain preparation was used (e.g., high dose, double strength) or as a “moderate CYP3A inhibitor” when another preparation was used (e.g., low dose, single strength).

 

8 USE IN SPECIFIC POPULATIONS 

 

8.1 Pregnancy 

 

Risk Summary 

 

Based on findings from animal studies and the mechanism of action, ALIQOPA can cause fetal harm when administered 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 reproduction studies, administration of copanlisib to pregnant rats during organogenesis resulted in embryo-fetal death and fetal abnormalities at maternal doses approximately 12% of the recommended dose for patients (see Data). 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. The background 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 clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data 

 

Animal Data