Not Approved (US) Sexual & Reproductive Health

Carbetocin

also known as: Pabal, Duratocin, Lonactene, Heat-Stable Carbetocin (HSC)

Ferring's Pabal / Duratocin — a long-acting oxytocin analog used for prevention of postpartum hemorrhage after cesarean delivery. Approved in Canada, the UK, the EU, and (as heat-stable carbetocin) prequalified by WHO for low-resource settings. Not FDA-approved: the FDA declined to approve the product in 2006 and it has not been re-filed.

A synthetic long-acting oxytocin analog (1-deamino-1-monocarba-2-O-methyltyrosine-oxytocin) developed by Ferring, with a plasma half-life of approximately 40 minutes — roughly 4–10× longer than native oxytocin — supporting single-dose use for postpartum hemorrhage prevention after cesarean delivery. Approved in Canada (Duratocin, 1997), the EU and UK (Pabal), and many other jurisdictions. A room-temperature-stable formulation (heat-stable carbetocin, HSC) was prequalified by the WHO in 2019 for use in low-resource settings without cold-chain infrastructure. The FDA declined to approve carbetocin in 2006 and Ferring has not re-filed.

Mechanism of action

Selective OXTR agonism on uterine myometrium, producing sustained tonic and phasic uterine contractions that compress uterine blood vessels and reduce postpartum bleeding. Minimal vasopressin-receptor activity. Longer half-life than oxytocin enables single-dose use in place of a prolonged oxytocin infusion.

Primary uses

Prevention of postpartum hemorrhage (uterine atony) after elective cesarean delivery (ex-US)
Prevention of postpartum hemorrhage after vaginal delivery (heat-stable carbetocin, WHO-prequalified, low-resource settings)

Typical dosing

100 mcg single dose (intravenous (slow bolus) or intramuscular)

Elective cesarean: 100 mcg as single slow IV injection over ≥1 minute, immediately after delivery of the infant, preferably before delivery of the placenta. Vaginal PPH prophylaxis (heat-stable carbetocin, WHO setting): 100 mcg IM after delivery.

Regulatory status

Approved in Canada as Duratocin (1997), the EU and UK as Pabal, and widely internationally (Lonactene, Lonact, Femilac). Indicated for prevention of uterine atony and excessive bleeding after elective cesarean delivery. Heat-stable carbetocin (HSC) was WHO-prequalified in 2019 for use in low-resource settings. FDA issued a non-approval letter in 2006 citing study-design concerns; Ferring has not re-filed. Not approved in the United States.

References

[other] Pabal (carbetocin) Summary of Product Characteristics. Electronic Medicines Compendium (eMC), United Kingdom.
[pubmed] Widmer M, et al. "Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth." N Engl J Med, 2018;379:743-752 (CHAMPION trial, non-inferiority).
[other] World Health Organization. "WHO Prequalification of Medicines: Heat-Stable Carbetocin." 2019.

Related peptides

Oxytocin

An endogenous nine-amino-acid hormone with roles in labor, lactation, and social-affiliative behavior; also explored off-label for social/anxiety research.

Atosiban

Ferring's Tractocile — an oxytocin-receptor antagonist used in Europe and elsewhere as a tocolytic for short-term suppression of preterm labor between 24 and 33 weeks' gestation. Approved by the EMA in 2000; the FDA declined to approve atosiban in 1998 citing a higher fetal/infant death rate in the <26-week subgroup of the pivotal trial.

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.