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[This article belongs to Volume - 26, Issue - 02]

EVALUATION OF TERATOGENIC PROFILE OF COMBINATION OF LUMACAFTOR AND IVACAFTOR IN NEW ZEALAND WHITE RABBITS.

Teratogenicity, the potential to induce fetal defects, is a pivotal concern in teratology. This study investigated the teratogenic profile resulting from the combined administration of Lumacaftor and Ivacaftor in pregnant New Zealand White rabbits. Lumacaftor-Ivacaftor, a CFTR modulator therapy, has revolutionized cystic fibrosis treatment. A total of 112 pregnant rabbits were divided into control, vehicle control, Maximum Recommended Human Dose (MRHD), 10 times of Maximum Recommended Human Dose (10MRHD), 25 times of Maximum Recommended Human Dose (25MRHD) and 50 times of Maximum Recommended Human Dose (50MRHD). The combination of Lumacaftor and Ivacaftor was administered during gestation days 6-19, with observations on clinical parameters, body weight changes, water intake, food consumption, morbidity, mortality, and reproductive performance. Statistical analyses were performed using ANOVA and the chi-square test. Results indicated no significant differences in maternal body weight, water intake, and food consumption across treatment groups. Clinical observations revealed no abnormalities in the central nervous system, autonomic nervous system, eyes, skin, or hair. No mortality occurred, and reproductive performance, including the Mating, Delivery, and Birth Live Indices, remained consistent across groups. No external, visceral, or skeletal abnormalities were observed in the examined rabbit fetuses. The study concludes that Lumacaftor-Ivacaftor, even at doses up to 50 times MRHD, did not induce teratogenic effects in New Zealand White rabbits.