Two Cases of Cardiovascular Adverse Events Following Subcutaneous Vosoritide Injection in Early Infancy.

Nishioka A, Adachi N, Tanaka H, Oda Y

Cureus5 May 2024Cited by 4 (Europe PMC)

PMID38841012PMCIDPMC11150171DOI10.7759/cureus.59695PepBankPUB-38841012

Summary

Achondroplasia, characterized by short stature and skeletal abnormalities, is caused by a gain-of-function variant in the fibroblast growth factor receptor 3 gene. Vosoritide, a C-type natriuretic peptide analog, is an emerging treatment for achondroplasia that functions by promoting endochondral ossification. Vosoritide was approved for the treatment of achondroplasia in Europe and the United States in 2021, and in Japan, the following year. However, vosoritide is associated with a risk of hypotension and vomiting after subcutaneous injection due to its vasodilating effect. Herein, we present two cases of cardiovascular adverse events in infants following vosoritide injection. Case 1 involved a one-month-old female infant with achondroplasia who received the first subcutaneous injection of vosoritide 30 minutes after her last formula intake. Following injection, she developed transient symptomatic hypotension accompanied by vomiting. Although established guidelines recommend that injections be administered after approximately 30 minutes (Europe/Japan) or within one hour (USA) following the last feeding, an extended interval of 1.5 to two hours was required to prevent hypotension-associated vomiting. Case 2 involved a three-month-old female infant with achondroplasia. The first subcutaneous vosoritide injection was administered four hours after the last formula intake, and she subsequently developed prolonged compensated shock with marked tachycardia requiring intervention, including repetitive bolus saline injection. These cases indicate the need to monitor patients for cardiovascular adverse events following subcutaneous injection of vosoritide in early infancy.

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanCase report or seriesSafety outcome
In a one-month-old infant with achondroplasia, the first vosoritide injection was followed by transient symptomatic hypotension.
In plain wordsA one-month-old infant developed temporary symptomatic low blood pressure after the first vosoritide injection.
Peptide
Vosoritide
Outcome
Not applicableSymptomatic hypotension in case 1
Study
n = 1
Outcome group
Adverse events · Cardiovascular
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Following injection, she developed transient symptomatic hypotension accompanied by vomiting.
2 context sentences(design, population, supporting numbers)
Summary · context
Case 1 involved a one-month-old female infant with achondroplasia who received the first subcutaneous injection of vosoritide 30 minutes after her last formula intake.
Summary · context
Herein, we present two cases of cardiovascular adverse events in infants following vosoritide injection.
Show in the study text Report a problemFND-3884101201
02HumanCase report or seriesSafety outcome
In a one-month-old infant with achondroplasia, the first vosoritide injection was followed by vomiting accompanying hypotension.
In plain wordsA one-month-old infant vomited with low blood pressure after the first vosoritide injection.
Peptide
Vosoritide
Outcome
Not applicableVomiting in case 1
Study
n = 1
Outcome group
Adverse events · Gastrointestinal
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Following injection, she developed transient symptomatic hypotension accompanied by vomiting.
2 context sentences(design, population, supporting numbers)
Summary · context
Case 1 involved a one-month-old female infant with achondroplasia who received the first subcutaneous injection of vosoritide 30 minutes after her last formula intake.
Summary · context
Herein, we present two cases of cardiovascular adverse events in infants following vosoritide injection.
Show in the study text Report a problemFND-3884101202
03HumanCase report or seriesSafety outcome
In an infant receiving vosoritide, a feeding-to-injection interval of 1.5 to two hours was required to prevent hypotension-associated vomiting.
In plain wordsAn infant receiving vosoritide required a longer feeding-to-injection interval to prevent vomiting associated with low blood pressure.
Peptide
Vosoritide
Outcome
Not applicableFeeding interval to prevent hypotension-associated vomiting
Study
n = 1
Outcome group
Adverse events · Cardiovascular
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Feeding-to-injection interval required
1.5 to 2 hours
Case 1 infant
Source sentences
Summary
an extended interval of 1.5 to two hours was required to prevent hypotension-associated vomiting.
2 context sentences(design, population, supporting numbers)
Summary · context
Case 1 involved a one-month-old female infant with achondroplasia who received the first subcutaneous injection of vosoritide 30 minutes after her last formula intake.
Summary · context
Herein, we present two cases of cardiovascular adverse events in infants following vosoritide injection.
Show in the study text Report a problemFND-3884101203
04HumanCase report or seriesSafety outcome
In a three-month-old infant with achondroplasia, the first vosoritide injection was followed by prolonged compensated shock requiring repetitive bolus saline.
In plain wordsA three-month-old infant developed prolonged compensated shock after the first vosoritide injection and needed repeated saline doses.
Peptide
Vosoritide
Outcome
Not applicableCompensated shock in case 2
Study
n = 1
Outcome group
Adverse events · Cardiovascular
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
The first subcutaneous vosoritide injection was administered four hours after the last formula intake, and she subsequently developed prolonged compensated shock with marked tachycardia requiring intervention, including repetitive bolus saline injection.
2 context sentences(design, population, supporting numbers)
Summary · context
Case 2 involved a three-month-old female infant with achondroplasia.
Summary · context
Herein, we present two cases of cardiovascular adverse events in infants following vosoritide injection.
Show in the study text Report a problemFND-3884101204
05HumanCase report or seriesSafety outcome
In a three-month-old infant with achondroplasia, the first vosoritide injection was followed by marked tachycardia with compensated shock.
In plain wordsA three-month-old infant developed a markedly fast heartbeat with compensated shock after the first vosoritide injection.
Peptide
Vosoritide
Outcome
Not applicableTachycardia in case 2
Study
n = 1
Outcome group
Adverse events · Cardiovascular
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
The first subcutaneous vosoritide injection was administered four hours after the last formula intake, and she subsequently developed prolonged compensated shock with marked tachycardia requiring intervention, including repetitive bolus saline injection.
2 context sentences(design, population, supporting numbers)
Summary · context
Case 2 involved a three-month-old female infant with achondroplasia.
Summary · context
Herein, we present two cases of cardiovascular adverse events in infants following vosoritide injection.
Show in the study text Report a problemFND-3884101205

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Version history

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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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