Regulatory Decision Summary for DURATOCIN
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Duratocin (carbetocin injection) is proposed for an expanded indication of prevention of uterine atony and postpartum hemorrhage from "elective caesarean section" to "caesarean section" (both elective and emergency) under epidural or spinal anesthesia. The Canadian Product Monograph has also been updated to include additional safety information with regard to cardiovascular disease, water intoxication, eclampsia and pre-eclampsia, gestational diabetes, migraine, epilepsy, asthma, drug interaction, based on published information.
Why was the decision issued?
The submission included the results of 3 clinical trials during which women undergoing delivery by caesarean section were to receive the study drug or oxytocin, a uterotonic medication already approved in Canada for the proposed indication. The 3 studies used the same design (randomized, double-blind, controlled) and took place in different hospitals under the supervision of investigators independent from the sponsor of the submission. The main objective of these studies was to compare the efficacy and the safety of carbetocin and oxytocin for preventing postpartum hemorrhage when caesarean section was required for elective or urgent reasons.
The uterotonic effect of this drug when administered immediately after the birth of the infant has, in all three clinical trials, limited blood losses and prevented postpartum hemorrhage defined by the World Health Organization (WHO) as blood losses exceeding 1,000 mL. This results in lower incidence of maternal anemia, lower risk of postpartum infection, lesser need of blood transfusions with their associated potential complications and faster recovery of the mother from the surgical procedure.
The profile of adverse events is similar to the previous indication. Common serious side effects of carbetocin include low blood pressure, chest pain, rapid heartbeat. Other side effects such as nausea, vomiting, stomach pain, metallic taste in the mouth, back pain are also observed after the delivery. Most of those reactions are transient in nature. Therefore, the benefit-risk profile of Duratocin (carbetocin) is considered to be positive in the expanded indication.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations