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Adverse event reporting can be found at the bottom of the page

About SomavertAbout Somavert

Learn about the efficacy and safety of Somavert, its tumour impact and its effect on co-morbidity management through clinical and real world data

About SomavertEfficacySafety profileDosingTumour impact
ReimbursementFunding and Reimbursement

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Acromegaly AcademyAcromegaly Academy

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Advice and support services to help you and your patients optimise your experience with Somavert about the efficacy and safety of Somavert through clinical and real world data

Supporting your patientsUsing SomavertStarter kitsHomecareAcroQoL Survey Healthcare professional and patient materialsVideosMaterialsGot any questions?Endocrine HelplineContact us

Click here for Somavert® (pegvisomant) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

TitleSomavert is used in the treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-I concentrations or was not tolerated.
Tumour ImpactThe majority of pituitary tumours remain stable with Somavert1
  • Treatment-resistant tumour progression occurs in a small minority of patients with acromegaly, regardless of treatment modality2
  • When no tumour growth is observed in the first 18 months of treatment with Somavert,it is unlikely that any growth will occur subsequently3
  • As growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable.4
A proportion of patients from ACROSTUDY1 were anaylsed, looking at tumour stability:

MRI analysis showed a low incidence for tumour volume increase suggesting this is not promoted by pegvisomant treatment.1

- 2162 patients analysed for pituitary imaging


Changes in Tumour Size via Local and Central MRI Analysis:1

1795 patients were reported to have  ≥1 pituitary imaging result after pegvisomant initiation

Local MRI Analysis:1
•    28.9% (n=519) of patients showed a change in tumour size (increase, decrease or both)
•    71.1% (n=1276) of patients showed no change in pituitary tumour size

Central MRI Analysis:1
As per the protocol, patients showing a change in tumour size through local MRI analysis were reassessed through a central reader. This was not required during the voluntary extension phase of the study.
•    264 out of 519 patients were re-assessed for a change in tumour size via central analysis
•    3% (54/1795) of patients showed an increase in tumour size
•    0.7% (12/1795) of patients showed an increase and decrease in tumour size


Changes in pituitary tumour size were reported as AEs of special interest in 96 (4.3%) of cases (24 (1.1%) considered treatment related) and caused 31 (1.4%) patients to discontinue pegvisomant treatment.1

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References

M Fleseriu, et al. Eur J Endocrinol. 2021 Aug 27;185(4):525-538Besser GM et al. Predictors and rates of treatment-resistant tumor growth in acromegaly. Eur J Endocrinol 2005;153:187–93.Jiminez et al., Follow-up of pituitary tumour volume in patients with acromegaly treated with pegvisomant in clinical trials. European Journal of Endocrinology 2008: 159(5): 517–23.Somavert Summary of Product Characteristics.  Great Britain available here. Northern Ireland available here
PP-SOM-GBR-1314. January 2024

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