Carbetocin Aguettant

What Is Carbetocin Aguettant and What Is It Used For?

Carbetocin Aguettant contains the active substance carbetocin, a long-acting synthetic analogue of the naturally occurring hormone oxytocin. Oxytocin is a hormone produced by the body that plays a critical role during labor and delivery, stimulating uterine contractions and facilitating delivery of the placenta. After birth, continued uterine contraction is essential to compress the blood vessels at the placental site, thereby reducing blood loss.

Carbetocin Aguettant is specifically indicated for the prevention of uterine atony and postpartum hemorrhage (PPH) following delivery of the infant. PPH is defined by the World Health Organization (WHO) as blood loss of 500 mL or more within 24 hours after birth, and it remains one of the leading causes of maternal mortality worldwide, accounting for approximately 27% of all maternal deaths globally. Uterine atony—the failure of the uterus to contract adequately after delivery—is the most common cause of PPH, responsible for approximately 70-80% of all cases.

In some women, the uterus (womb) does not contract sufficiently quickly or strongly after delivery, which can lead to greater than normal blood loss. Carbetocin binds to oxytocin receptors on the smooth muscle of the uterus, stimulating rhythmic uterine contractions and increasing the resting tone of the myometrium. This mechanism helps compress the spiral arteries at the former placental site, significantly reducing the risk of hemorrhage.

The key advantage of carbetocin over conventional oxytocin is its significantly longer duration of action. While oxytocin typically requires continuous intravenous infusion and has a plasma half-life of only 3-17 minutes, carbetocin achieves sustained uterine activity for approximately 60 minutes following a single injection. This prolonged effect is due to structural modifications that make carbetocin more resistant to enzymatic degradation by aminopeptidases and disulfidases in the circulation.

According to the WHO Model List of Essential Medicines (2023), carbetocin is listed as an alternative uterotonic agent for prevention of PPH. A landmark WHO-led randomized controlled trial (CHAMPION trial, 2018) involving over 29,000 women across 10 countries demonstrated that heat-stable carbetocin was non-inferior to oxytocin for the prevention of PPH after vaginal birth. This finding has significant implications for low-resource settings where maintaining cold-chain storage for oxytocin can be challenging.

What Should You Know Before Receiving Carbetocin Aguettant?

Carbetocin Aguettant must only be administered after the baby has been delivered. Before receiving this medication, your healthcare provider needs to be aware of your complete medical history, including any current conditions and all other medications you are taking. It is critical to inform your medical team of any new symptoms that develop during or after treatment.

Contraindications

There are several situations in which carbetocin must not be administered. These absolute contraindications are based on the European Medicines Agency (EMA) approved Summary of Product Characteristics (SmPC) and reflect the potential for serious adverse outcomes:

The prohibition against use during pregnancy and labor is particularly critical. Administering carbetocin before delivery could cause dangerously strong and sustained uterine contractions (uterine hyperstimulation), which can lead to uterine rupture, fetal distress, and potentially fatal outcomes for both mother and child. Similarly, carbetocin must never be used for induction or augmentation of labor because its prolonged duration of action makes it unsuitable for controlled management of labor contractions.

Patients with hepatic or renal impairment should not receive carbetocin because the drug is primarily metabolized and eliminated through these organ systems. Impaired hepatic or renal function could lead to significantly elevated plasma concentrations and prolonged pharmacological effects, increasing the risk of adverse events including uterine hyperstimulation and cardiovascular complications.

Warnings and Precautions

Even in the absence of absolute contraindications, certain conditions require heightened medical vigilance when using carbetocin. Inform your healthcare team before receiving Carbetocin Aguettant if you experience or have a history of any of the following:

• Migraine: Carbetocin can cause headache and fluid retention, which may exacerbate migraine symptoms.
• Asthma: The medication may affect respiratory function, and patients with asthma should be monitored closely.
• Pre-eclampsia or eclampsia: These pregnancy-related conditions involving hypertension and organ damage require careful assessment before administering any uterotonic agent, as carbetocin can affect blood pressure and fluid balance.
• Cardiovascular conditions including hypertension: Carbetocin can cause changes in heart rate and blood pressure. Patients with underlying cardiovascular disease are at greater risk for cardiac adverse effects.
• Any other medical conditions: Your healthcare provider should conduct a thorough risk-benefit assessment based on your individual clinical circumstances.

Children and Adolescents

Carbetocin Aguettant is not intended for use in children under 12 years of age. Experience with use in adolescents is limited. The clinical context of this medication—prevention of PPH after childbirth—means that the relevant patient population is typically adult women of reproductive age.

Drug Interactions

Inform your healthcare team about all medications you are currently taking, have recently taken, or might take. Although formal drug interaction studies with carbetocin are limited, potential interactions exist based on the pharmacological profile of the drug and its class effects:

Pregnancy and Breastfeeding

Carbetocin must not be used during pregnancy or labor before the baby is born. Its sole indication is for post-delivery use. Using carbetocin before delivery could cause dangerous uterine hyperstimulation, placing both mother and fetus at significant risk.

Regarding breastfeeding, small amounts of carbetocin have been shown to pass from the mother's blood into breast milk. However, this is not expected to cause harm to the nursing infant because carbetocin is a peptide that is rapidly broken down in the infant's gastrointestinal tract before it can be absorbed into the bloodstream. Breastfeeding does not need to be restricted after receiving Carbetocin Aguettant. The WHO considers carbetocin compatible with breastfeeding, and some evidence suggests that oxytocin-like compounds may actually facilitate the let-down reflex and support breastfeeding initiation.

How Does Carbetocin Aguettant Interact with Other Drugs?

Drug interactions with carbetocin are primarily of clinical concern in the obstetric setting, where multiple pharmacological agents may be administered during the peripartum period. Because carbetocin is given as a single dose in a controlled hospital environment, the interaction profile is relatively manageable, but awareness of potential interactions is essential for patient safety.

Major Interactions

The most significant interactions involve other uterotonic agents. The concurrent administration of carbetocin with oxytocin, ergometrine (methylergonovine), or prostaglandin analogues such as misoprostol can result in an additive or synergistic increase in uterine contractility. This excessive stimulation can lead to uterine hyperstimulation, characterized by excessively frequent contractions (tachysystole) with inadequate relaxation between contractions, or sustained tetanic contraction. In severe cases, this can cause uterine rupture, a life-threatening emergency. Therefore, concurrent use of carbetocin with other uterotonic agents is contraindicated.

If PPH persists despite carbetocin administration, sequential use of other uterotonics may be considered, but only after an appropriate interval and under careful clinical monitoring. The decision to escalate uterotonic therapy should follow established PPH management protocols such as those outlined by the International Federation of Gynecology and Obstetrics (FIGO) and the Royal College of Obstetricians and Gynaecologists (RCOG).

Minor Interactions

Volatile inhalational anesthetics (such as halothane, isoflurane, and sevoflurane) may reduce the uterotonic response to carbetocin. These agents cause dose-dependent uterine relaxation by inhibiting myometrial contractility. When general anesthesia with volatile agents is used for cesarean section, the anesthetist should be aware that the uterotonic response to carbetocin may be diminished, and additional measures to control uterine bleeding may be necessary.

Epidural and spinal anesthetics, particularly those containing vasoconstrictors such as epinephrine, may interact with the cardiovascular effects of carbetocin. Both regional anesthesia and carbetocin can cause hypotension, and the additive hypotensive effect should be anticipated. Intravenous fluid preloading and vasopressor availability should be ensured as part of standard anesthetic practice.

What Is the Correct Dosage of Carbetocin Aguettant?

Carbetocin Aguettant is administered exclusively in a supervised hospital or birthing facility setting by trained healthcare professionals. The medication comes as a ready-to-use pre-filled syringe, and its administration does not require any reconstitution or dilution. The dosing regimen is straightforward, reflecting the drug's design as a single-dose uterotonic agent.

Adults

Children

Carbetocin Aguettant is not intended for use in children under 12 years. The clinical indication—prevention of PPH after childbirth—is relevant only to women of childbearing age. There are limited data on the use of carbetocin in adolescent mothers, and dosing in this group should follow the standard adult regimen under specialist obstetric supervision.

Elderly

Given the clinical context of postpartum use, carbetocin is not typically administered to elderly patients. No specific dose adjustment data are available for older women. Should administration be required in an older parturient, standard dosing applies with careful monitoring of cardiovascular and renal status.

Missed Dose

The concept of a missed dose is not directly applicable to carbetocin because it is given as a single dose in a supervised clinical setting. If for any reason the intended dose is not administered immediately after delivery, the decision to administer it at a later time should be made by the supervising obstetrician based on clinical assessment of uterine tone and bleeding status. Alternative uterotonic agents may be considered if a significant delay has occurred.

Overdose

What Are the Side Effects of Carbetocin Aguettant?

Like all medicines, Carbetocin Aguettant can cause side effects, although not everyone experiences them. The frequency and severity of side effects differ depending on the route of administration. Side effects tend to be more common and pronounced after intravenous injection (used following cesarean section) compared with intramuscular injection (used following vaginal delivery).

The following side effect profiles are based on data from clinical trials and post-marketing surveillance reported in the EMA-approved product information. Understanding these potential effects helps healthcare providers monitor patients appropriately and manage symptoms when they occur.

After Cesarean Section (Intravenous Administration)

After Vaginal Delivery (Intramuscular Administration)

Side effects that have been observed with similar products (such as oxytocin) and may potentially occur with carbetocin include: slow heart rate (bradycardia), irregular heartbeat (arrhythmia), chest pain, fainting (syncope), and palpitations that may indicate cardiac dysfunction. These cardiovascular effects are particularly important to monitor in patients with pre-existing heart conditions.

Reporting Side Effects

Reporting suspected adverse reactions after a medicine has been authorized is important for ongoing monitoring of the benefit-risk balance. Healthcare professionals and patients are encouraged to report side effects through their national pharmacovigilance reporting system. In the United Kingdom, reports can be submitted through the Yellow Card Scheme. In the European Union, reports go through the EudraVigilance system. In the United States, the FDA MedWatch system accepts adverse event reports.

How Should You Store Carbetocin Aguettant?

Proper storage of Carbetocin Aguettant is essential to maintain the stability and efficacy of the medication. As a peptide-based pharmaceutical product, carbetocin is sensitive to temperature and light degradation. The following storage requirements must be strictly observed:

• Temperature: Store in a refrigerator at 2–8°C (36–46°F). Do not freeze.
• Light protection: Keep the pre-filled syringes in the original carton to protect from light. Carbetocin is light-sensitive and exposure to light can degrade the active substance.
• Access: Keep out of the sight and reach of children.
• Expiry: Do not use after the expiry date printed on the carton after "EXP." The expiry date refers to the last day of the indicated month.
• Disposal: Do not dispose of unused medicines via household waste. Return any unused pre-filled syringes to a pharmacy or appropriate disposal facility.

It is worth noting that the WHO has been actively promoting research into heat-stable formulations of carbetocin that do not require refrigeration. A heat-stable formulation (not requiring cold-chain storage) has been developed and assessed in the WHO CHAMPION trial. This formulation, stored at up to 30°C and 75% relative humidity for 36 months, maintained adequate stability and was found to be non-inferior to refrigerated oxytocin for PPH prevention. However, the Carbetocin Aguettant formulation described in this guide (pre-filled syringe) still requires refrigerated storage as specified above.

What Does Carbetocin Aguettant Contain?

Active Ingredient

The active substance is carbetocin. Each pre-filled syringe contains 1 mL of solution providing 100 micrograms of carbetocin. Carbetocin is a synthetic long-acting analogue of the naturally occurring posterior pituitary hormone oxytocin. It is a cyclic nonapeptide with a molecular formula of C₄₅H₆₉N₁₁O₁₂S and a molecular weight of approximately 988.2 Da. The key structural modification compared to oxytocin is the replacement of the disulfide bridge with a thioether linkage and deamination of the N-terminal cysteine, which confers resistance to enzymatic degradation and extends the duration of action.

Inactive Ingredients (Excipients)

• Sodium chloride: Used as a tonicity agent to make the solution isotonic with body fluids, ensuring compatibility with intravenous and intramuscular administration.
• Glacial acetic acid: Used for pH adjustment to ensure the solution is at an appropriate pH for stability and compatibility.
• Water for injections: The solvent base for the injectable solution, meeting pharmacopoeial standards for sterility and purity.

Appearance and Packaging

Carbetocin Aguettant is a clear and colorless solution for injection supplied in pre-filled syringes that are ready for intravenous or intramuscular use. The product is available in packs of 5 pre-filled syringes, each containing 1 mL of solution. The syringes are packaged in a carton that protects them from light during storage.

Manufacturer

The marketing authorization holder is Laboratoire Aguettant, based in Lyon, France. The manufacturing site is GP-PHARM, S.A., located in Sant Quinti de Mediona, Spain. Both facilities operate under Good Manufacturing Practice (GMP) standards as required by European Union pharmaceutical regulations.