Ζopapogene imadenovec

There are no available data with zopapogene imadenovec in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with zopapogene imadenovec. In the PRGN-2012-201 study, one patient reported pregnancy at 6 months following completion of treatment with zopapogene imadenovec. The patient delivered at 40 weeks without any reported birth complications or neonatal concerns.

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.

There is no information available on the presence of zopapogene imadenovec in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zopapogene imadenovec and any potential adverse effects on the breastfed child from zopapogene imadenovec or from the underlying maternal condition.

No animal studies have been performed to evaluate the effects of zopapogene imadenovec on carcinogenesis, mutagenesis, or impairment of fertility.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described in this section reflects exposure to zopapogene imadenovec in one clinical study (Study PRGN-2012-201). A total of 38 adults with recurrent respiratory papillomatosis received a zopapogene imadenovec dose of either 1×10¹¹ PU (n=3), or 5×10¹¹ PU (n=35) per injection on Days 1, 15, 43, and 85. The most common adverse reactions (incidence ≥5%) are summarized in the following table.

Adverse Reactions occurring in ≥5% of Patients in Study PRGN-2012-201 (N=38):

^* Graded per NCI CTCAE v5.0. There were no Grade >2 adverse reactions.

Other clinically significant adverse reactions occurring in <5% of patients included vision blurred (3%), injection site bruising (3%), dizziness (3%), dyspnea (3%), and pruritus (3%).