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

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

Title

Example

Welcome to Somavert!Use this page to find information to support your prescribing of Somavert. 
To order starter kits and other consumables, click hereLoading
Indication

Somavert 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.1

Safety

ACROSTUDY:
Over 2000 patients participated in the ACROSTUDY which aimed to report the final long-term safety and efficacy analyses of patients with acromegaly treated with Somavert (pegvisomant), which confirmed the overall favourable benefit-to-risk profile.2


For full details on side effects and selected adverse reactions please refer to the Somavert Summary of Product Characteristics
 

Scroll left to view table
Most Common Adverse Events Adverse Events of Interest
Headache (25%)1
 
Abnormal liver results
(≥1/100 to <1/10)1
- 3.2% of 2221 patients from ACROSTUDY had ALT/AST > 3 x ULN2
- No reports of liver failure in the study2
Arthralgia (16%)1
 
Injection site reactions
(≥1/100 to <1/10)1
 
- 2% of 2221 patients from ACROSTUDY had treatment-related injection site reactions2
- Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued. Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.1
Diarrhoea (13%)1
 


Monitoring of liver tests (LT)

Liver function should be assessed at baseline and monitored every 4-6 weeks for the first 6 months of treatment, or at any time in patients exhibiting symptoms suggestive of hepatitis. More frequent if elevations are detected at baseline.1

For full details regarding the assessment and monitoring of liver function please refer to the Summary of Product Characteristics

Efficacy

Somavert can help achieve high rates of IGF-I normalisation1,3,4

Somavert IGF-I normalisation rates at 12 weeks3

 

Example

Study design: 12-week, randomised, double-blind study of three different doses of pegvisomant (10mg, 15mg, and 20mg) and placebo, given subcutaneously daily, in 112 patients with acromegaly. All patients had previously been treated with surgery, radiation therapy and/or medical therapies.3
 

Somavert normalised serum IGF-I levels in 97% (87 of 90) of patients with appropriate dose titration and close patient follow up4

Somavert normalised serum IGF-1 levels in 97% (87 of 90) of patients with appropriate dose titration and close patient follow up3

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Baseline and lowest values of individual serum IGF-I concentrations achieved in 90 patients treated for 12 months or more with daily injections.4
 

The shaded area represents age adjusted normal range for IGF-I4
 

Study design: Prospective, open-label, 18-month, multicentre extension study that assessed the effects of Somavert in 160 patents with acromegaly treated for an average of 425 days.4
 

Van der Lely 2001: 87/90 patients taking pegvisomant for 12 months or more.4
 

100/108  (92.6%) of patients with available IGF-I data had a normal IGF-I concentration at any visit during pegvisomant treatment. 2/100 patients with normalised IGF-I were administered doses of >30mg/day5

The maximum licensed dose of Somavert should not exceed 30mg per day. Please refer to the Summary of Product Characteristics before prescribing Somavert.1

Somavert's tumour-independent mechanism of action may explain how it can achieve IGF-1 normalisation rates of up to 97% when appropriately titrated (n=87/90)

Dosing

Somavert is a daily subcutaneous injection available in five vial sizes of 10 mg, 15 mg, 20 mg, 25 mg and 30 mg
 

A loading dose of 80mg Somavert should be administered subcutaneously under medical supervision.  Following this, 10mg Somavert should be administered once daily as a sub-cutaneous injection.1
 

Dose adjustments should be based on serum IGF-I levels. Serum IGF-I concentrations should be measured every four to six weeks and appropriate dose adjustments made in increments of 5 mg/day in order to maintain the serum IGF-I concentration within the age-adjusted normal range and to maintain an optimal therapeutic response.1
 

The dose range of Somavert is 10-30mg daily.  The maximum dose should not exceed 30mg/day.1

Storage
  • Store the powder vials in a refrigerator (2°C – 8°C). However, the cartons containing the powder vials may be stored at room temperature up to a maximum of 25°C for a single period of up to 30 days.† 
  • Keep the vial(s) in their carton(s) in order to protect from light. 
  • Store the pre-filled syringe(s) below <30°C or store in a refrigerator (2°C - 8°C). Do not freeze

Please refer to the Summary of Product Characteristics for the full information regarding storage

Starting Somavert

Homecare
We offer an at home medication delivery service and face to face nursing support through a range of providers.

  • Free and flexible home delivery service of Somavert 
  • Standard Homecare service: up to 2 face-to-face or virtual home nurse visits  ​​​​​​​

Starter Kit:

Each Somavert starter kit contains*:
​​​​
  • Somavert training device
  • Injection pad (for practising technique)
  • Box of swabs
  • Sharps bin

*subject to availability and contents may vary

Please note that Pfizer is no longer able to provide cool bags for patients travelling with their medication.

Somavert Administration Video
Watch an acromegaly patient demonstrate how to administer Somavert


References:
 

Somavert Summary of Product Characteristics: Click here.Fleseriu M, et al. More then a decate of real-world experience of pegvisomant for acromegaly: ACROSTUDY. Eur J Endocrinol, 2021;185(4):525-38.Trainer PJ, et al. Treatment of Acromegaly with the growth hormone -receptor antagonist pegvisomant. N Engl J Med 2000; 342(16) :1171-7Van der Lely AJ, et al. Long-term treatment of acromegaly with pegvisomant, a growth hormone receptor antagonist. Lancet 2001;24;358(9295):1754–9.Pfizer Data on file: PP-SOM-GBR-1104
PP-SOM-GBR-1388. March 2025.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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