Carbetocin

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Carbetocin
  2. Carbetocin: From Prader-Willi Syndrome to Isotretinoin-like Syndrome
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Singapore Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Carbetocin: From Prader-Willi Syndrome to Isotretinoin-like Syndrome

One-Sentence Summary

Carbetocin is an oxytocin receptor agonist. It is registered in Singapore as an injectable and is used to prevent postpartum haemorrhage due to uterine atony. Its knowledge-graph indications are Prader-Willi syndrome and Noonan syndrome. The TxGNN model predicts it may be effective for isotretinoin-like syndrome, but no clinical trials and no relevant publications currently support this prediction. This is a model-only prediction (Evidence Level L5).

Quick Overview

Item Content
Original Indication Prader-Willi syndrome, Noonan syndrome (knowledge-graph indications; the Singapore licence has no approved indication text recorded)
Predicted New Indication Isotretinoin-like syndrome
TxGNN Prediction Score 99.15%
Evidence Level L5
Singapore Market Status ✓ Marketed
Number of Registrations 1
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Pharmacology data identifies carbetocin as a peptide agonist of the oxytocin receptor (OXTR). It is used to prevent postpartum haemorrhage due to uterine atony. An intranasal formulation (LV-101) has been in development for hyperphagia in Prader-Willi syndrome.

No plausible link between oxytocin receptor agonism and isotretinoin-like syndrome, a congenital malformation syndrome, could be verified from the available data. The high score (0.991) most likely reflects graph-based similarity to other congenital syndromes rather than a validated biological mechanism. The model ranked this prediction 9,415th overall, so the score should be interpreted cautiously.

Among the other top-ranked predictions, two have a more coherent rationale and are flagged as research questions:

  • Prader-Willi syndrome due to paternal deletion of 15q11q13 (score 99.0%): a molecular subtype of an existing indication. The oxytocin system is plausibly involved, since oxytocin-producing neurons in the hypothalamus are reduced in this condition.
  • Partial deletion of the long arm of chromosome 15 (score 98.9%): this may overlap the 15q11-q13 region, but the phenotype depends on the exact deleted region.

The remaining top-10 predictions (Goodman syndrome, brachymorphism-onychodysplasia-dysphalangism syndrome, Mietens syndrome, hydrocephalus-costovertebral dysplasia-Sprengel anomaly syndrome, lethal faciocardiomelic dysplasia, symptomatic Coffin-Lowry syndrome in female carriers, and hypoglossia-hypodactyly syndrome) have no clinical or literature support and no verifiable mechanism.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available for isotretinoin-like syndrome.

Singapore Market Information

Authorization Number Product Name Dosage Form Approved Indication
SIN15173P DURATOCIN RTS SOLUTION FOR INJECTION 100 MCG/ML (Ferring GmbH) Injection, solution Not recorded in the data compiled for this report

Safety Considerations

  • Drug Interactions: The interaction query found only a pharmacological target relationship (oxytocin receptor, OXTR), not a drug-drug interaction. No interacting drugs were identified.
  • Cardiac signal (from a case report on a different topic): One retrieved case report described chest pain and electrocardiographic signs of myocardial ischaemia right after carbetocin was given during a caesarean delivery, in a patient with an anomalous right coronary artery. It is a single case, but it suggests cardiovascular caution.

Package insert warnings and contraindications were not available. Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction for isotretinoin-like syndrome rests only on a graph-based score. There are no trials, no relevant publications, and no verifiable mechanism linking oxytocin receptor agonism to this condition. The three publications retrieved for the sixth-ranked prediction are keyword-matched noise (a bioinformatics study, an obstetric case report, a veterinary study). They do not support any new indication.

To proceed, the following is needed:

  • Package insert warnings and contraindications from the HSA website, which block safety screening
  • Mechanism of action data for carbetocin (for example, from DrugBank)
  • A literature review specific to isotretinoin-like syndrome and the oxytocin pathway
  • Route compatibility assessment, since the Singapore product is injectable and any new use may need a different route
  • Consideration of the Prader-Willi 15q11q13 deletion subtype and 15q deletions as research questions, using evidence from the parent Prader-Willi indication and external sources

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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