About Somavert
Indicated for 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.
Click here for Somavert (pegvisomant) Prescribing Information.
Somavert normalises IGF-I in a unique way1
Somavert mechanism of action |
Somavert works on cell surfaces around the body, directly targeting and blocking growth hormone receptors to inhibit IGF-I production with a high predictability1-3 |
Somavert can help achieve high rates of IGF-I normalisation1,3
Somavert IGF-I normalisation rates at 12 weeks and 12 months |
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Somavert’s tumour-independent mechanism of action may explain how it can achieve IGF-I normalisation rates of up to 97% when appropriately titrated (n=90, p<0.05)3 |
*p=0.02. **p<0.001. Maximum recommended dose of Somavert should not exceed 30 mg daily.1
Somavert seeks to minimise the impact of acromegaly on quality of life
Somavert symptom score reductions at 6 months |
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Patients on Somavert report significant reductions versus baseline in soft tissue swelling, headache, joint pain and general physical condition, and total signs and symptoms score‡1,5 |
‡Total signs and symptoms score reduction observed at 12 weeks (p<0.05, n=112).1
References
- Somavert Summary of Product Characteristics. December 2020. Available at https://www.medicines.org.uk/emc/medicine/14353
- Sherlock M, et al. Medical therapy in acromegaly. Nat Rev Endocrinol 2011;7:291–300.
- van der Lely AJ, et al. Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet 2001;24;358(9295):1754–9.
- Trainer PJ, et al. Treatment of acromegaly with the growth hormone-receptor antagonist pegvisomant. N Engl J Med 2000;342(16):1171–7.
- Schreiber I, et al. Treatment of acromegaly with the GH receptor antagonist pegvisomant in clinical practice: Safety and efficacy evaluation from the German Pegvisomant Observational Study. Eur J Endocrinol 2007;156:75–82.
PP-SOM-GBR-0765. December 2020.
Somavert has an established safety and tolerability profile1–3
Somavert safety profile |
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Over 2000 patients have participated in ACROSTUDY, the global safety surveillance study for Somavert to date, giving us a wealth of information about possible adverse events1,2 |
Monitoring of liver tests
Liver function should be monitored at baseline and every 4–6 weeks on treatment, and more frequently if elevations are detected1
References
- Somavert Summary of Product Characteristics. December 2020. Available at https://www.medicines.org.uk/emc/medicine/14353
- ACROSTUDY data on file. Final study report. November 2018.
- Buchfelder M, et al. Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY. Eur J Endocrinol, 2018;179(6):419–27.
PP-SOM-GBR-0765. December 2020.
The majority of pituitary tumours remain stable with Somavert1
- Although Somavert does not directly act on the pituitary tumour, 96.3% of patients experience maintained or decreased tumour size while on Somavert*1
- 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 assessed by local ± central MRI analysis.
Tumour stability during ACROSTUDY1,4 |
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References
- ACROSTUDY data on file. Final study report. November 2018.
- Besser 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.
- Buchfelder M, et al. Long-term treatment with pegvisomant: observations from 2090 acromegaly patients in ACROSTUDY. Eur J Endocrinol, 2018;179(6):419–27.
PP-SOM-GBR-0765. December 2020.
Somavert both directly and indirectly impacts common acromegaly comorbidities
Glucose homeostasis significantly improved versus baseline1,2 -1.4 mmol/L fasting plasma glucose reduction, -0.4% HbA1c reduction versus baseline at 8 months, n=52, p≤0.0011 |
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CV risk significantly reduced versus baseline3 Framingham Risk Score reduced from 13.9 at baseline to 11.3 at 12 months, n=62, p=0.0053 |
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Sleep apnoea severity significantly reduced versus baseline4 Apnoea–Hypopnoea index decreased from 23 at baseline to 18 at 6 months, n=12, p=0.074 |
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Impact on aspects of glucose homeostasis of switching from octreotide LAR* to Somavert at 8 months |
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Impact on blood pressure of Somavert-mediated IGF-I normalisation at 12 months (n=62) |
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Impact of switching to Somavert (n=62) on Framingham Risk Score at 12 months3 |
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Impact on obstructive sleep apnoea (OSA) of switching to Somavert (n=12) at 6 months4 |
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References
- Barkan AL, et al. Glucose Homeostasis and Safety in Patients with Acromegaly Converted from Long-Acting Octreotide to Pegvisomant. J Clin Endocrinol Metab 2005;90(1):5684–91.
- Drake, et al. Insulin sensitivity and glucose tolerance improve in patients with acromegaly converted from depot octreotide to pegvisomant. Eur J Endocrinol 2003;149(6):521–7.
- Berg C, et al. Cardiovascular risk factors in patients with uncontrolled and long-term acromegaly: comparison with matched data from the general population and the effect of disease control. J Clin Endocrinol Metab 2010;95(8):3648–56.
- Berg C, et al. Influence of disease control with pegvisomant on sleep apnoea and tongue volume in patients with active acromegaly. Eur J Endocrinol 2009;161:829–35.
- Sandostatin® LAR® Summary of Product Characteristics. February 2020. Available at: https://www.medicines.org.uk/emc/product/1038/smpc
- Pasireotide Summary of Product Characteristics. August 2020. Available at: https://www.medicines.org.uk/emc/product/9396/smpc
PP-SOM-GBR-0765. December 2020.