A Case of Inadvertent Overdose of Vosoritide Injection in a Three-Month-Old Infant With Achondroplasia.

Satake S, Oda Y

Cureus17 Aug 2026

PMID42757154PMCIDPMC13584173DOI10.7759/cureus.114690PepBankPUB-42757154

Summary

Vosoritide, a recombinant C-type natriuretic peptide analog that antagonizes fibroblast growth factor receptor 3 (FGFR3) signaling, is recommended for early initiation in infants with achondroplasia. However, clinical safety data for infants under six months remain limited, and concerns persist regarding its potential to induce symptomatic hypotension. We present a case of a three-month-old female infant with genetically confirmed achondroplasia (FGFR3 p.Gly380Arg) who accidentally received an inadvertent double dose of vosoritide (0.24 mg; 53 μg/kg) during home self-injection therapy. This patient remained completely asymptomatic, exhibiting no signs of hypotension, lethargy, or facial pallor during home monitoring. While findings from a single patient cannot definitively establish safety, the complete absence of adverse reactions after an accidental overdose suggests substantial inter-individual variability in hemodynamic sensitivity to vosoritide during early infancy. This clinical observation provides insights into the drug's tolerability profile in young infants.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanCase report or seriesSafety outcome
The infant remained asymptomatic after an accidental double dose of vosoritide during home monitoring.
In plain wordsThe infant remained asymptomatic after an accidental double dose of vosoritide during home monitoring.
Peptide
Vosoritide
Outcome
Not applicableSymptoms after accidental double dose
Study
n = 1
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg; 53 μg/kg · injectionAs given in this study (human).
Source sentences
Summary
This patient remained completely asymptomatic, exhibiting no signs of hypotension, lethargy, or facial pallor during home monitoring.
1 context sentence(design, population, supporting numbers)
Summary · context
We present a case of a three-month-old female infant with genetically confirmed achondroplasia (FGFR3 p.Gly380Arg) who accidentally received an inadvertent double dose of vosoritide (0.24 mg; 53 μg/kg) during home self-injection therapy.
Show in the study text Report a problemFND-4275715401
02HumanCase report or seriesSafety outcome
The infant showed no signs of hypotension after an accidental double dose of vosoritide.
In plain wordsThe infant showed no signs of hypotension after an accidental double dose of vosoritide.
Peptide
Vosoritide
Outcome
Not applicableHypotension
Study
n = 1
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg; 53 μg/kg · injectionAs given in this study (human).
Source sentences
Summary
This patient remained completely asymptomatic, exhibiting no signs of hypotension, lethargy, or facial pallor during home monitoring.
1 context sentence(design, population, supporting numbers)
Summary · context
We present a case of a three-month-old female infant with genetically confirmed achondroplasia (FGFR3 p.Gly380Arg) who accidentally received an inadvertent double dose of vosoritide (0.24 mg; 53 μg/kg) during home self-injection therapy.
Show in the study text Report a problemFND-4275715402
03HumanCase report or seriesSafety outcome
The infant showed no lethargy after an accidental double dose of vosoritide.
In plain wordsThe infant showed no lethargy after an accidental double dose of vosoritide.
Peptide
Vosoritide
Outcome
Not applicableLethargy
Study
n = 1
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg; 53 μg/kg · injectionAs given in this study (human).
Source sentences
Summary
This patient remained completely asymptomatic, exhibiting no signs of hypotension, lethargy, or facial pallor during home monitoring.
1 context sentence(design, population, supporting numbers)
Summary · context
We present a case of a three-month-old female infant with genetically confirmed achondroplasia (FGFR3 p.Gly380Arg) who accidentally received an inadvertent double dose of vosoritide (0.24 mg; 53 μg/kg) during home self-injection therapy.
Show in the study text Report a problemFND-4275715403
04HumanCase report or seriesSafety outcome
The infant showed no facial pallor after an accidental double dose of vosoritide.
In plain wordsThe infant showed no facial pallor after an accidental double dose of vosoritide.
Peptide
Vosoritide
Outcome
Not applicableFacial pallor
Study
n = 1
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg; 53 μg/kg · injectionAs given in this study (human).
Source sentences
Summary
This patient remained completely asymptomatic, exhibiting no signs of hypotension, lethargy, or facial pallor during home monitoring.
1 context sentence(design, population, supporting numbers)
Summary · context
We present a case of a three-month-old female infant with genetically confirmed achondroplasia (FGFR3 p.Gly380Arg) who accidentally received an inadvertent double dose of vosoritide (0.24 mg; 53 μg/kg) during home self-injection therapy.
Show in the study text Report a problemFND-4275715404

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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