Somavert

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1.  NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 10 mg powder and solvent for solution for injection 
SOMAVERT 15 mg powder and solvent for solution for injection 
SOMAVERT 20 mg powder and solvent for solution for injection 
SOMAVERT 25 mg powder and solvent for solution for injection 
SOMAVERT 30 mg powder and solvent for solution for injection 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
SOMAVERT 10 mg powder and solvent for solution for injection 
One vial contains 10 mg of pegvisomant. 
After reconstitution, 1 ml of solution contains 10 mg of pegvisomant.* 
 
Excipient with known effect 
 
The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. 
 
SOMAVERT 15 mg powder and solvent for solution for injection 
One vial contains 15 mg of pegvisomant. 
After reconstitution, 1 ml of solution contains 15 mg of pegvisomant.* 
 
Excipient with known effect 
 
The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. 
 
SOMAVERT 20 mg powder and solvent for solution for injection 
One vial contains 20 mg of pegvisomant. 
After reconstitution, 1 ml of solution contains 20 mg of pegvisomant.* 
 
Excipient with known effect: 
 
The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder. 
 
SOMAVERT 25 mg powder and solvent for solution for injection 
One vial contains 25 mg of pegvisomant. 
After reconstitution, 1 ml of solution contains 25 mg of pegvisomant.* 
 
Excipient with known effect 
 
The 25 mg strength of the medicinal product contains 0.5 mg of sodium per vial of powder. 
 
SOMAVERT 30 mg powder and solvent for solution for injection 
One vial contains 30 mg of pegvisomant. 
After reconstitution, 1 ml of solution contains 30 mg of pegvisomant.* 
 
Excipient with known effect 
 
The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder. 
 
*produced in Escherichia coli cells by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 



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3.  PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection (powder for injection). 
 
The powder is white to slightly off-white. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1.  Therapeutic indications 
 
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 
normalize IGF-I concentrations or was not tolerated. 
 
4.2.  Posology and method of administration 
 
Treatment should be initiated under the supervision of a physician experienced in the treatment of 
acromegaly. 
 
Posology 
 
A loading dose of 80 mg pegvisomant should be administered subcutaneously under medical 
supervision. Following this, SOMAVERT 10 mg reconstituted in 1 ml of solvent should be 
administered once daily as a subcutaneous injection. 
 
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. 
 
Assessment of baseline levels of liver enzymes prior to initiation of SOMAVERT 
Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests 
(LTs) [serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin 
(TBIL), and alkaline phosphatase (ALP)]. For recommendations regarding initiation of SOMAVERT 
based on baseline LTs and recommendations for monitoring of LTs while on SOMAVERT, refer to 
Table A in Special warnings and precautions for use (4.4). 
 
The maximum dose should not exceed 30 mg/day. 
 
For the different dose regimens, the following strengths are available: SOMAVERT 10 mg, 
SOMAVERT 15 mg, SOMAVERT 20 mg, SOMAVERT 25 mg and SOMAVERT 30 mg. 
 
Paediatric population 
The safety and efficacy of SOMAVERT in children aged 0 to 17 years have not been established. No 
data are available. 
 
Elderly 
No dose adjustment is required. 
 
Hepatic or renal impairment 
The safety and efficacy of SOMAVERT in patients with renal or hepatic insufficiency has not been 
established. 
 
Method of administration 
 
Pegvisomant should be administered by subcutaneous injection. 



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The site of injection should be rotated daily to help prevent lipohypertrophy. 
 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
 
4.3.  Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4.  Special warnings and precautions for use 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Growth hormone-secreting tumours 
 
Growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications 
(for example, visual field defects). Treatment by pegvisomant does not reduce tumour size. All 
patients with these tumours should be carefully monitored in order to avoid any eventual progression 
in tumour size under treatment. 
 
Serum IGF-1 monitoring 
 
Pegvisomant is a potent antagonist of growth hormone action. A growth hormone deficient state may 
result from administration of this medicinal product, despite the presence of elevated serum growth 
hormone levels. Serum IGF-I concentrations should be monitored and maintained within the 
age-adjusted normal range by adjustment of the pegvisomant dose. 
 
ALT or AST elevations 
 
Prior to the start of SOMAVERT, patients should have an assessment of baseline levels of liver tests 
[serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin 
(TBIL), and alkaline phosphatase (ALP)].  
Evidence of obstructive biliary tract disease should be ruled out in patients with elevations of ALT and 
AST or in patients with a prior history of treatment with any somatostatin analogue. Administration of 
pegvisomant should be discontinued if signs of liver disease persist. 
For recommendations regarding initiation of SOMAVERT, based on baseline liver tests (LTs) and 
recommendations for monitoring of liver tests while on SOMAVERT, refer to Table A. 
 



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Table A: Recommendations for initiation of SOMAVERT treatment based on baseline LTs and 
for periodic monitoring of LTs during SOMAVERT treatment 

Baseline LT Levels Recommendations

Normal 

 May treat with SOMAVERT.  
 Serum concentrations of ALT and AST should be 

monitored at 4- to 6-week intervals for the first 6 months 
of treatment with SOMAVERT, or at any time in patients 
exhibiting symptoms suggestive of hepatitis. 

Elevated, but less than or 
equal to 3 times ULN 

 May treat with SOMAVERT; however, monitor LTs 
monthly for at least 1 year after initiation of therapy and 
then bi-annually for the next year.

Greater than 3 times ULN 

 Do not treat with SOMAVERT until a comprehensive 
workup establishes the cause of the patient’s liver 
dysfunction. 

 Determine if cholelithiasis or choledocholithiasis is 
present, particularly in patients with a history of prior 
therapy with somatostatin analogs.  

 Based on the workup, consider initiation of therapy with 
SOMAVERT.  

 If the decision is to treat, LTs and clinical symptoms 
should be monitored very closely.

Abbreviations: ALT = alanine aminotransferase; AST = aspartate transaminase; LT = liver test; 
ULN = upper limit of normal. 
 
If a patient develops LT elevations, or any other signs or symptoms of liver dysfunction while 
receiving SOMAVERT, the following patient management is recommended (Table B). 
 
Table B. Clinical recommendations based on abnormal liver test results while on SOMAVERT 
 

LT Levels and Clinical 
Signs/Symptoms 

Recommendations 

Elevated, but less than or equal to 
3 times ULN 

 May continue therapy with SOMAVERT. However, monitor 
LTs monthly to determine if further increases occur. 

Greater than 3 but less than 5 times 
ULN (without signs/symptoms of 
hepatitis or other liver injury, or 
increase in serum TBIL)  

 May continue therapy with SOMAVERT. However, monitor 
LTs weekly to determine if further increases occur (see 
below). 

 Perform a comprehensive hepatic workup to discern if  an 
alternative cause of liver dysfunction is present.  

At least 5 times ULN, or transaminase 
elevations at least 3 times ULN 
associated with any increase in serum 
TBIL (with or without 
signs/symptoms of hepatitis or other 
liver injury) 

 Discontinue SOMAVERT immediately. 
 Perform a comprehensive hepatic workup, including serial 

LTs, to determine if and when serum levels return to normal. 
 If LTs normalize (regardless of whether an alternative cause 

of the liver dysfunction is discovered), consider cautious 
reinitiation of therapy with SOMAVERT, with frequent LT 
monitoring.

Signs or symptoms suggestive of 
hepatitis or other liver injury (e.g., 
jaundice, bilirubinuria, fatigue, 
nausea, vomiting, right upper quadrant 
pain, ascites, unexplained oedema, 
easy bruisability)  

 Immediately perform a comprehensive hepatic workup.  
 If liver injury is confirmed, the drug should be discontinued. 

 
Hypoglycaemia 
 
The study conducted with pegvisomant in diabetic patients treated either by insulin or by oral 
hypoglycaemic medicinal products revealed the risk of hypoglycaemia in this population. Therefore, 



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in acromegalic patients with diabetes mellitus, doses of insulin or hypoglycaemic medicinal products 
may need to be decreased (see section 4.5). 
 
Improved fertility 
 
The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the 
patient’s clinical condition could potentially also improve fertility in female patients (see section 4.6). 
 
Pregnancy 
 
Acromegaly control may improve during pregnancy. Pegvisomant is not recommended during 
pregnancy (see section 4.6). If pegvisomant is used during pregnancy, IGF-I levels should be closely 
monitored and pegvisomant doses may need to be adjusted (see section 4.2) based on IGF-I values. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose. Patients on low sodium 
diets can be informed that this medicinal product is essentially ‘sodium-free’. 
 
4.5.  Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. It should be considered whether to continue treatment 
with somatostatin analogues. The use of this medicine in combination with other medicinal products 
for the treatment of acromegaly has not been extensively investigated. 
 
Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of 
these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4). 
 
Pegvisomant has significant structural similarity to growth hormone which causes it to cross-react in 
commercially available growth hormone assays. Since serum concentrations of 
therapeutically-effective doses of this medicine are generally 100 to 1000 times higher than the actual 
serum growth hormone concentrations seen in acromegalics, measurements of serum growth hormone 
concentrations will be spuriously reported in commercially available growth hormone assays. 
Pegvisomant treatment should therefore not be monitored or adjusted based on serum growth hormone 
concentrations reported from these assays. 
 
4.6.  Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are limited amount of data from the use of pegvisomant in pregnant women. Animal studies are 
insufficient with respect to reproductive toxicity (see section 5.3). 
 
SOMAVERT is not recommended during pregnancy and in women of childbearing potential not using 
contraception. 
 
If pegvisomant is used during pregnancy, IGF-I levels should be closely monitored, especially during 
the first trimester. It may be necessary to adjust the dose of pegvisomant during pregnancy (see section 
4.4). 
 
Breast-feeding 
 
The excretion of pegvisomant in breast milk has not been studied in animals. Clinical data are too 
limited (one reported case) to draw any conclusion on the excretion of pegvisomant in human breast 
milk. Therefore, pegvisomant should not be used in breast-feeding women. However, breast-feeding 
may be continued if this medicine is discontinued: this decision should take into account the benefit of 
pegvisomant therapy to the mother and the benefit of breast-feeding to the child. 



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Fertility 
 
For pegvisomant no data on fertility are available. 
 
The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the 
patient’s clinical condition could potentially also improve fertility in female patients. 
 
4.7.  Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
4.8.  Undesirable effects 
 
Summary of the safety profile 
 
The list below contains adverse reactions seen in clinical trials with SOMAVERT. 
 
In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse reactions to 
pegvisomant were of mild to moderate intensity, of limited duration and did not require 
discontinuation of treatment. 
 
The most commonly reported adverse reactions occurring in  10% of patients with acromegaly 
treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea 
13%. 
 
Tabulated list of adverse reactions 
 
The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, 
classified by system organ class and frequency. 
 
Adverse reactions are listed according to the following categories: 
Very common: 1/10 
Common:  1/100 to <1/10 
Uncommon:  1/1,000 to <1/100 
Not known (cannot be estimated from the available data) 
 
System Organ Class Very 

Common 
(≥1/10) 

Common 
(≥1/100 

to <1/10) 
 

Uncommon 
(≥1/1,000 to < 

1/100) 
 

Frequency 
Not Known 
(Cannot Be 
Estimated 

From 
Available 

Data)
Blood and lymphatic 
system disorders 

  thrombocytopenia, 
leukopenia, 
leukocytosis, 
haemorrhagic 
diathesis

 

Immune system 
disorders 

  hypersensitivity 
reactionsb 

anaphylactic 
reactionb, 
anaphylactoid 
reactionb 



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System Organ Class Very 
Common 
(≥1/10) 

Common 
(≥1/100 

to <1/10) 
 

Uncommon 
(≥1/1,000 to < 

1/100) 
 

Frequency 
Not Known 
(Cannot Be 
Estimated 

From 
Available 

Data)
Metabolism and 
nutrition disorders 

 hypercholesterol
aemia, 
hyperglycaemia, 
hypoglycaemia, 
weight increased

hypertriglyceridemia  

Psychiatric disorders  abnormal dreams panic attack, short 
term memory loss, 
apathy, confusion, 
sleep disorder, libido 
increased

anger 

Nervous system 
disorders 

headache somnolence, 
tremor, 
dizziness, 
hypoaesthesia

narcolepsy, migraine, 
dysgeusia 

 

Eye disorders  eye pain asthenopia  

Ear and labyrinth 
disorders 

  Meniere’s disease  

Cardiac disorders  oedema 
peripheral

  

Vascular disorders   hypertension   

Respiratory, thoracic 
and mediastinal 
disorders 

 dyspnoea  laryngospasmb 

Gastrointestinal 
disorders 

diarrhoea vomiting, 
constipation, 
nausea, 
abdominal 
distension, 
dyspepsia, 
flatulence

haemorrhoids, 
salivary 
hypersecretion, dry 
mouth, tooth 
disorder 

 

Hepatobiliary 
disorders 

 abnormal liver 
function tests 
(e.g. 
transaminase 
elevation) (see 
section 4.4)

  

Skin and subcutaneous 
tissue disorders 

 hyperhidrosis, 
contusion, 
pruritusb, rashb 

face oedema, dry 
skin, increased 
tendency to bruise, 
night sweats, 
erythemab, urticariab 

angioedemab 

Musculoskeletal and 
connective tissue 
disorders 

arthralgia  myalgia, arthritis   

Renal and urinary 
disorders 

 haematuria proteinuria, polyuria, 
renal impairment

 



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System Organ Class Very 
Common 
(≥1/10) 

Common 
(≥1/100 

to <1/10) 
 

Uncommon 
(≥1/1,000 to < 

1/100) 
 

Frequency 
Not Known 
(Cannot Be 
Estimated 

From 
Available 

Data)
General disorders and 
administration site 
conditions  

 injection site 
reaction 
(including 
injection site 
hypersensitivity), 
injection site 
bruising or 
bleeding, 
injection site 
hypertrophy 
(e.g. lipohypertro
phy)a, 
influenza-like 
illness, fatigue, 
asthenia, pyrexia 

feeling abnormal, 
impaired healing, 
hunger 

 

a see Description of selected adverse reactions below 
b ADR related to hypersensitivity reaction 
 
Description of selected adverse reactions 
 
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. 
 
The development of isolated low-titre anti-growth hormone antibodies was observed in 16.9% of 
patients treated with pegvisomant. The clinical significance of these antibodies is unknown. 
 
Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, 
angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria) have been reported in post 
marketing use. Some patients required hospitalization. Upon re-administration, symptoms did not 
re-occur in all patients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9.  Overdose 
 
There is limited experience of overdose with pegvisomant. In the one reported incident of acute 
overdose, where 80 mg/day was administered for 7 days, the patient experienced a slight increase in 
fatigue and dry mouth. In the week following discontinuation of treatment the adverse reactions noted 
were: insomnia, increased fatigue, oedema peripheral, tremor, and weight gain. Two weeks after 
stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was 
observed which were considered possibly related to pegvisomant. 
 
In cases of overdose, administration of this medicine should be discontinued and not resumed until 
IGF-I levels return to within or above the normal range. 



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5.  PHARMACOLOGICAL PROPERTIES 
 
5.1.  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other anterior pituitary lobe hormones and analogues, ATC code: 
H01AX01. 
 
Mechanism of action 
 
Pegvisomant is an analogue of human growth hormone that has been genetically modified to be a 
growth hormone receptor antagonist. Pegvisomant binds to growth hormone receptors on cell surfaces, 
where it blocks growth hormone binding, and thus interferes with intracellular growth hormone signal 
transduction. Pegvisomant is highly selective for the GH receptor, and does not cross-react with other 
cytokine receptors, including prolactin. 
 
Pharmacodynamic effects  
 
Inhibition of growth hormone action with pegvisomant leads to decreased serum concentrations of 
insulin-like growth factor-I (IGF-I), as well as other growth hormone-responsive serum proteins such 
as free IGF-I, the acid-labile subunit of IGF-I (ALS), and insulin-like growth factor binding protein-3 
(IGFBP-3).  
 
Clinical efficacy and safety 
 
Acromegalic patients (n=112) have been treated in a 12-week, randomised, double-blind, multicentre 
study comparing placebo and pegvisomant. Dose-dependent, statistically significant reductions in 
mean IGF-I (p<0.0001), free IGF-I (p<0.05), IGFBP-3 (p<0.05) and ALS (p<0.05) were observed at 
all post-baseline visits in the pegvisomant treatment groups. The serum IGF-1 was normalised at the 
end of the study (week 12) in 9.7%, 38.5%, 75% and 82% of subjects treated with placebo, 10 mg/day, 
15 mg/day or 20 mg/day pegvisomant respectively.  
 
Statistically significant differences from placebo (p<0.05) were observed for improvements in the total 
signs and symptoms score for all dose groups compared to placebo. 
 
A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study 
for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks). The mean 
IGF-I concentration in this cohort fell from 917 ng/ml to 299 ng/ml on pegvisomant, with 92% 
achieving a normal (age-adjusted) IGF-I concentration. 
 
5.2.  Pharmacokinetic properties 
 
Absorption 
 
Absorption of pegvisomant following subcutaneous administration is slow and prolonged, and peak 
serum pegvisomant concentrations are not generally attained until 33-77 hours after administration. 
The mean extent of absorption of a subcutaneous dose was 57% relative to an intravenous dose. 
 
Distribution 
 
The apparent volume of distribution of pegvisomant is relatively small (7-12 L). 
 
Biotransformation 
 
The metabolism of pegvisomant has not been studied. 
 



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Elimination 
 
The mean total body systemic clearance of pegvisomant following multiple doses is estimated to be 
28 ml/h for subcutaneous doses ranging from 10 to 20 mg/day. Renal clearance of pegvisomant is 
negligible and accounts for less than 1% of total body clearance. Pegvisomant is slowly eliminated 
from serum, with mean estimates of half-life generally ranging from 74 to 172 hours following either 
single or multiple-doses. 
 
Linearity/non-linearity 
 
After single subcutaneous pegvisomant administration no linearity is observed with rising doses of 
10, 15 or 20 mg. Approximately linear pharmacokinetics is observed at steady state in the population 
pharmacokinetic studies. The data from 145 patients in two long-term studies who received daily 
doses of 10, 15, or 20 mg, demonstrate pegvisomant mean serum concentrations (± SD) of 
approximately 8800 ± 6300, 13200 ± 8000 and 15600 ± 10300 ng/ml, respectively. 
 
The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly 
patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than 
lighter individuals, and may thus require greater doses of pegvisomant. 
 
5.3.  Preclinical safety data 
 
Non-clinical data revealed no special hazard for humans based on studies of repeated dose toxicity in 
rat and monkey. However, due to the marked pharmacological response in monkey, systemic 
exposures higher than those achieved in patients at therapeutic doses have not been studied.  
 
Malignant fibrous histiocytomas associated with fibrosis and histiocytic inflammation were observed 
at injection sites in males in the rat carcinogenicity study at exposure levels equivalent to three times 
the human exposure based on mean plasma concentrations in two long-term studies at a daily dose of 
30 mg. The relevance of this response for humans is currently unknown. The increased incidence of 
injection site tumours was most probably caused by irritation and the high sensitivity of the rat to 
repeated subcutaneous injections. 
 
Early embryonic development and embryo-foetal development studies were conducted in pregnant 
rabbits with pegvisomant at subcutaneous doses of 1, 3, and 10 mg/kg/day. There was no evidence of 
teratogenic effects associated with pegvisomant administration during organogenesis. At 
10 mg/kg/day (6 times the maximum human therapeutic dose based on body surface area), an increase 
in post-implantation loss was observed in both studies. No fertility study has been conducted. 
 
 
6.  PHARMACEUTICAL PARTICULARS 
 
6.1.  List of excipients 
 
Powder: 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous  
Sodium dihydrogen phosphate monohydrate 
 
Solvent: 
Water for Injections  
 
6.2.  Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 



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6.3.  Shelf life 
 
3 years. 
 
After reconstitution, the product should be used immediately. 
 
6.4.  Special precautions for storage 
 
Store the powder vial(s) in a refrigerator (2C – 8C). Do not freeze. Keep the vial(s) in their carton(s) 
in order to protect from light. 
 
The carton(s) containing the SOMAVERT powder vial(s) may be stored at room temperature up to a 
maximum of 25°C for a single period of up to 30 days. The Use by date should be written on the 
carton (up to 30 days from the date removed from the refrigerator). The vial(s) must be protected from 
light and should not be placed back into the refrigerator. The  SOMAVERT powder vial(s) must be 
discarded if not used within the 30 days of room temperature storage or the expiry date printed on the 
carton, whichever is earlier. 
 
Store the pre-filled syringe(s) below 30C or store in a refrigerator (2ºC - 8°C). Do not freeze. 
 
After reconstitution: 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5.  Nature and contents of container 
 
10 mg or 15 mg or 20 mg or 25 mg or 30 mg of pegvisomant in powder in a vial (type I flint glass) 
with a stopper (chlorobutyl rubber) and 1 ml solvent (water for injections) in a pre-filled syringe 
(type I borosilicate glass) with a plunger stopper (bromobutyl rubber) and a tip cap (bromobutyl 
rubber). The colour of the protective plastic cap is specific to the strength of the product. 
 
SOMAVERT 10 mg and 15 mg 
Pack size of 30 vials, pre-filled syringes and safety needles. 
 
SOMAVERT 20 mg, 25 mg and 30 mg 
Pack sizes of 1 and 30 vial(s), pre-filled syringe(s) and safety needle(s) 
 
Not all pack sizes may be marketed. 
 
6.6.  Special precautions for disposal and other handling 
 
The syringe and safety needle used to administer the injection are provided with the medicinal 
product. 
 



 13

Before attaching the supplied safety needle the syringe cap will need to be removed from the pre-filled 
syringe. This is achieved by snapping it off. The syringe should be kept upright to avoid leakage and 
the end of the syringe should not be allowed to contact anything. 
 

 
 
The powder should be reconstituted with 1 ml solvent. When adding the solvent from the syringe the 
vial and syringe should held at an angle as shown in the diagram below. 
 

 
 
Add the solvent to the vial of powder. The solvent should be emptied into the vial slowly to avoid the 
possibility of a foam forming. This would make the medicine unusable. Gently dissolve the powder 
with a slow, swirling motion. Do not shake vigorously, as this might cause denaturation of the active 
substance. 
 
After reconstitution, the reconstituted solution should be inspected visually for extraneous (or for any 
foreign) particulate matter or any variation in physical appearance prior to administration. In the event 
of either being observed, discard the medicinal product. 
 



 14

Before withdrawing the dissolved SOMAVERT invert the vial with the syringe still inserted into it 
and ensure the gap in the stopper can be seen as shown in the diagram below: 

 
Pull the needle down so that the needle tip is at its lowest point in the liquid. Slowly withdraw the 
plunger in the syringe to withdraw the medicine from the vial. If air is seen in the syringe, tap the 
barrel to float the bubbles to the top, and then gently push the bubbles out into the vial. 
 
Before disposing of the syringe and needle fold the needle guard over the needle and ensure it clicks 
into place. The syringe and needle should never be reused. 
 
For single use only. Any unused medicinal product or waste material should be disposed of in 
accordance with local requirements.  
 
 
7.  MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/001 10 mg 30 vials 
EU/1/02/240/002 15 mg 30 vials 
EU/1/02/240/004 20 mg 1 vial 
EU/1/02/240/003 20 mg 30 vials 
EU/1/02/240/009 25 mg 1 vial 
EU/1/02/240/010 25 mg 30 vials 
EU/1/02/240/011 30 mg 1 vial 
EU/1/02/240/012 30 mg 30 vials 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorization: 13 November 2002 
Date of latest renewal: 20 September 2007 
 
 



 15

10.  DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
 



 16

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 



 17

A.  MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
Pfizer Health AB 
Mariefredsvagen 37 
645 41 Strängnäs 
Sweden 
 
Pfizer Ireland Pharmaceuticals 
Grange Castle Business Park 
Clondalkin 
Dublin 22 
Ireland 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Pfizer Manufacturing Belgium NV 
Rijksweg 12, 
B-2870 Puurs, 
Belgium 
 
 
B.  CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal.  
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 

USE OF THE MEDICINAL PRODUCT 
 
 Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 



 18

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 19

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 20

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 10 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 10 mg pegvisomant 
After reconstitution, 1 ml of solution contains 10 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
30 vials of powder 
30 pre-filled syringes of solvent 
30 injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 21

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store the powder vial(s) in a refrigerator. Do not freeze. 
Keep the powder vial(s) in their carton(s) in order to protect from light.  
Refer to the package leaflet for alternative storage details. 
Store the pre-filled syringe(s) below 30C or store in a refrigerator. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 10 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 22

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 23

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 10 mg powder for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 10 mg pegvisomant 
After reconstitution, 1 ml of solution contains 10 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection 
 
10 vials of powder 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 24

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the vial(s) in the carton(s) in order to protect from light. 
Powder vial(s) can be stored up to 25C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 10 mg 
 
 



 25

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING 
UNITS 
 
POWDER VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
SOMAVERT 10 mg 
powder for injection 
pegvisomant 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 mg 
 
 
6. OTHER 
 
 
 



 26

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 15 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 15 mg pegvisomant 
After reconstitution, 1 ml of solution contains 15 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
30 vials of powder 
30 pre-filled syringes of solvent 
30 injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 27

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store the powder vial(s) in a refrigerator. Do not freeze. 
Keep the powder vial(s) in their carton(s) in order to protect from light.  
Refer to package leaflet for alternative storage details. 
Store the pre-filled syringe(s) below 30C or store in a refrigerator. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 15 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 28

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 29

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 15 mg powder for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 15 mg pegvisomant 
After reconstitution, 1 ml of solution contains 15 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection 
 
10 vials of powder 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 30

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the vial(s) in the carton(s) in order to protect from light. 
Powder vial(s) can be stored up to 25C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 15 mg 
 
 



 31

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
POWDER VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
SOMAVERT 15 mg  
powder for injection 
pegvisomant 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
15 mg 
 
 
6. OTHER 
 
 
 



 32

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 20 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 20 mg pegvisomant 
After reconstitution, 1 ml of solution contains 20 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
30 vials of powder 
30 pre-filled syringes of solvent 
30 injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 33

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store the powder vial(s) in a refrigerator. Do not freeze. 
Keep the powder vial(s) in their carton(s) in order to protect from light.  
Refer to package leaflet for alternative storage details.  
Store the pre-filled syringe(s) below 30C or store in a refrigerator. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/003  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 34

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 35

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 20 mg powder for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 20 mg pegvisomant 
After reconstitution, 1 ml of solution contains 20 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection 
 
10 vials of powder 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 36

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the vial(s) in the carton(s) in order to protect from light. 
Powder vial(s) can be stored up to 25C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/003  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 20 mg 
 
 



 37

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 20 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 20 mg pegvisomant 
After reconstitution, 1 ml of solution contains 20 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
1 vial of powder 
1 pre-filled syringe of solvent 
1 injection needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 38

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the contents in the carton in order to protect from light.  
Carton can be stored up to 25C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/004  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 20 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 39

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 40

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
POWDER VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
SOMAVERT 20 mg 
powder for injection 
pegvisomant 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
20 mg 
 
 
6. OTHER 
 
 
 



 41

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 25 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 25 mg pegvisomant 
After reconstitution, 1 ml of solution contains 25 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
30 vials of powder 
30 pre-filled syringes of solvent 
30 injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 42

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store the powder vial(s) in a refrigerator. Do not freeze. 
Keep the powder vial(s) in their carton(s) in order to protect from light.  
Refer to package leaflet for alternative storage details. 
Store the pre-filled syringe(s) below 30C or store in a refrigerator. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 43

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 44

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 25 mg powder for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 25 mg pegvisomant 
After reconstitution, 1 ml of solution contains 25 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection 
 
10 vials of powder 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 45

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the vial(s) in the carton(s) in order to protect from light. 
Powder vial(s) can be stored up to 25°C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/010 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 25 mg 
 
 



 46

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 25 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 25 mg pegvisomant 
After reconstitution, 1 ml of solution contains 25 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
1 vial of powder 
1 pre-filled syringe of solvent 
1 injection needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 47

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the contents in the carton in order to protect from light. 
Carton can be stored up to 25C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/009 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 48

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



 49

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
POWDER VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
SOMAVERT 25 mg 
powder for injection 
pegvisomant 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
25 mg 
 
 
6. OTHER 
 
 
 



 50

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 30 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 30 mg pegvisomant 
After reconstitution, 1 ml of solution contains 30 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
30 vials of powder 
30 pre-filled syringes of solvent 
30 injection needles 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 51

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store the powder vial(s) in a refrigerator. Do not freeze. 
Keep the powder vial(s) in their carton(s) in order to protect from light.  
Refer to package leaflet for alternative storage details. 
Store the pre-filled syringe(s) below 30C or store in a refrigerator. Do not freeze. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 30 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE
 
2D barcode carrying the unique identifier included. 
 
 



 52

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 53

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INNER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 30 mg powder for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 30 mg pegvisomant 
After reconstitution, 1 ml of solution contains 30 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection 
 
10 vials of powder 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 



 54

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the vial(s) in the carton(s) in order to protect from light. 
Powder vial(s) can be stored up to 25°C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/012 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 30 mg 
 
 



 55

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
SOMAVERT 30 mg powder and solvent for solution for injection 
pegvisomant 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 30 mg pegvisomant 
After reconstitution, 1 ml of solution contains 30 mg pegvisomant 
 
 
3. LIST OF EXCIPIENTS 
 
Glycine 
Mannitol (E421) 
Disodium phosphate anhydrous 
Sodium dihydrogen phosphate monohydrate 
Water for Injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
 
1 vial of powder 
1 pre-filled syringe of solvent 
1 injection needle 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Use immediately after reconstitution. For single use only. 
 
 



 56

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
Keep the contents in the carton in order to protect from light. 
Carton can be stored up to 25C for a single period of up to 30 days. 
 
If stored at room temperature use by:___________________ 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium  
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/240/011 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
SOMAVERT 30 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



 57

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN 
 
 



 58

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
POWDER VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
SOMAVERT 30 mg 
powder for injection 
pegvisomant 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
30 mg 
 
 
6. OTHER 
 
 
 



 59

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS  
 
SOLVENT PRE-FILLED SYRINGE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for SOMAVERT  
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml water for injections 
 
 
6. OTHER 
 
 
 



 60

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 61

 
Package leaflet: Information for the user 

 
SOMAVERT 10 mg powder and solvent for solution for injection 
SOMAVERT 15 mg powder and solvent for solution for injection 
SOMAVERT 20 mg powder and solvent for solution for injection 
SOMAVERT 25 mg powder and solvent for solution for injection 
SOMAVERT 30 mg powder and solvent for solution for injection 

pegvisomant 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again 
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What SOMAVERT is and what it is used for 
2. What you need to know before you use SOMAVERT 
3. How to use SOMAVERT 
4. Possible side effects 
5. How to store SOMAVERT 
6. Contents of the pack and other information 
 
 
1. What SOMAVERT is and what it is used for  
 
SOMAVERT is used for the treatment of acromegaly, a hormonal disorder resulting from the 
increased secretion of growth hormone (GH) and IGF-I (Insulin-like growth factors), which is 
characterised by overgrowth of bone, soft tissue swelling, heart disease and related disorders. 
 
The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor 
antagonist. These substances decrease the action of GH and levels of IGF-I circulating in the blood. 
 
 
2. What you need to know before you use SOMAVERT 
 
Do not use SOMAVERT 
 If you are allergic to pegvisomant or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions 
Talk to your doctor, pharmacist or nurse before using SOMAVERT. 
 
- If you experience disturbed vision or headaches while using SOMAVERT you must contact 

your doctor immediately. 
 
- Your doctor or nurse will monitor the levels of IGF-I (Insulin-like growth factors) circulating in 

the blood and adjust the dose of SOMAVERT if necessary. 
 
- Your doctor should also monitor your adenoma (benign tumour). 
 



 62

- Your doctor will conduct tests of your liver function before starting and during treatment with 
SOMAVERT. If these test results are not normal, your doctor will discuss treatment options 
with you. Once treatment begins, your doctor or nurse will monitor the level of liver enzymes in 
the blood every 4-6 weeks for the first 6 months of treatment with SOMAVERT. Administration 
of SOMAVERT should be discontinued if signs of liver disease persist. 

 
- If you are diabetic, your doctor may need to adjust the amount of insulin or other medicines you 

are using. 
 
- Fertility in women patients may be increased as the disease improves. The use of this medicine 

in pregnant women is not recommended and women of childbearing age should be advised to 
use a contraception. See also the section about Pregnancy below. 

 
Other medicines and SOMAVERT 
You must tell your doctor if you have previously used other medicines for the treatment of acromegaly 
or medicines for the treatment of diabetes. 
 
Tell your doctor or pharmacist if you are using or have recently used any other medicines. 
 
As part of your treatment you may be given other medicines. It is important to keep using all your 
medicines as well as SOMAVERT unless you are told otherwise by your doctor, pharmacist or nurse. 
 
Pregnancy, breast-feeding and fertility 
The use of SOMAVERT in pregnant women is not recommended. If you are a women of childbearing 
age, a contraception should be used during treatment.  
 
It is not known if pegvisomant passes into breast milk. You should not breast-feed while taking 
SOMAVERT unless your doctor has discussed this with you. 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines 
No studies on the effects on the ability to drive and use machines have been performed. 
 
SOMAVERT contains sodium 
This medicine contains less than 1 mmol of sodium (23 mg) per dose i.e. essentially ‘sodium-free’. 
 
 
3. How to use SOMAVERT 
 
Always inject this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
A starting dose of 80 mg of pegvisomant will be given subcutaneously (just under the skin) by your 
doctor. Following this, the usual daily dose of pegvisomant is 10 mg, which is given by subcutaneous 
injection (just under the skin). 
 
Every four to six weeks your doctor will make appropriate dose adjustments, made in increments of 
5 mg pegvisomant/day, based on your so-called serum IGF-I levels to maintain an optimal therapeutic 
response.  
 



 63

Method and route of administration 
SOMAVERT is injected under the skin. The injection can be self-administered or given by another 
person, for example your doctor or his/her assistant. The detailed instructions on injection procedure 
provided at the end of this leaflet must be followed. You should continue to inject this medicine for as 
long as instructed by your doctor. 
 
This medicine must be dissolved before use. The injection must not be mixed in the same syringe or 
vial as any other medicine. 
 
Fatty tissue of the skin can build-up at the site of injection. To avoid this, use a slightly different place 
for your injection each time, as described in Step 2 of the ‘instructions for preparing and giving an 
injection of SOMAVERT’ section of this leaflet. This gives your skin and the area under your skin 
time to recover from one injection before it receives another one in the same place. 
 
If you have the impression that the effect of this medicine is too strong or too weak, talk to your 
doctor, pharmacist or nurse. 
 
If you inject more SOMAVERT than you should 
If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, 
but you should contact your doctor, pharmacist or nurse immediately. 
 
If you forget to use SOMAVERT 
If you forget to give yourself an injection you should inject the next dose as soon as you remember 
and then continue to inject SOMAVERT as prescribed by your doctor. Do not inject a double dose to 
make up for forgotten individual doses. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Mild to serious allergic (anaphylactic) reactions have been reported in some patients taking 
SOMAVERT. Symptoms of a serious allergic reaction may include one or more of the following: 
swelling of the face, tongue, lips, or throat; wheezing or trouble breathing (spasm of the larynx); 
generalized skin rash, nettle rash (urticaria) or itching; or dizziness. Contact your doctor immediately 
if you develop any of these symptoms. 
 
Very common may affect more than 1 in 10 people: 

 
 Headache 
 Diarrhoea 
 Joint pain 

 
Common: may affect up to 1 in 10 people 
 

 Shortness of breath. 
 Increased levels of substances that measure the function of the liver. These can be seen in the 

results of blood tests. 
 Blood in the urine. 
 Increased blood pressure. 
 Constipation, feeling sick, being sick, feeling bloated, indigestion, gas. 
 Dizziness, sleepiness, uncontrolled trembling, decreased sense of touch. 
 Bruising or bleeding at injection site, soreness or swelling at injection site, build-up of fat 

below the surface of the skin at injection site, swelling of the extremities, weakness, fever. 



 64

 Sweating, itching, rash, tendency to bruise. 
 Muscle pain, arthritis. 
 Increased blood cholesterol, weight gain, increased blood glucose, decreased blood glucose. 
 Flu-like illness, fatigue. 
 Abnormal dreams. 
 Eye pain 

 
Uncommon: may affect up to 1 in 100 people 
 

 Allergic reaction after administration (fever, rash, pruritus and, in severe cases, difficulty to 
breathe, rapid swelling of skin, requiring urgent medical attention). May occur immediately, 
or several days after administration. 

 Protein in the urine, increased urine, kidney problems. 
 Lack of interest, feeling confused, increased sex drive, panic attack, loss of memory, problems 

sleeping. 
 Decreased platelets in the blood, increased or decreased white cells in the blood, tendency to 

bleed. 
 Feeling abnormal, impaired healing. 
 Eyestrain, inner ear problems. 
 Facial swelling, dry skin, night sweats, redness of the skin (erythema), raised itchy bumps on 

the skin (urticaria). 
 Increased fatty substances in the blood, increased appetite. 
 Dry mouth, increased saliva, tooth problems, haemorrhoids. 
 Abnormal sense of taste, migraine. 

 
Not known: frequency cannot be estimated from the available data 
 

 Anger 
 Severe breathlessness (laryngospasm) 
 Rapid swelling of skin and underlying tissue and inner lining (mucosa) of organs 

(angioedema) 
 
About 17% of patients will develop antibodies to growth hormone during treatment. The antibodies do 
not seem to stop this medicine from working. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store SOMAVERT 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP. The 
expiry date refers to the last day of that month. 
 
Store the powder vial(s) in a refrigerator (2C – 8C) in their carton(s) in order to protect from light. 
Do not freeze.  
The carton(s) containing the SOMAVERT powder vial(s) may be stored at room temperature up to a 
maximum of 25°C for a single period of up to 30 days. Write the Use by date on the carton including 
day/month/year (up to 30 days from the date removed from the refrigerator). The vial(s) must be 
protected from light. Do not return this medicine to refrigerator. 
 



 65

Discard this medicine if not used by the new Use by date or the expiry date printed on the carton, 
whichever is earlier.  
Store the pre-filled syringe(s) below 30C or store in a refrigerator (2C – 8C). Do not freeze. 
 
After preparing the SOMAVERT solution it must be used immediately. 
 
Do not use this medicine if you notice that the solution is cloudy or contains particulate matter. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What SOMAVERT contains 
- The active substance is pegvisomant. 
- SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant. After reconstitution with 

1 ml of solvent, 1 ml of the solution contains 10 mg pegvisomant. 
- SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant. After reconstitution with 

1 ml of solvent, 1 ml of the solution contains 15 mg pegvisomant. 
- SOMAVERT 20 mg: One vial of powder contains 20 mg pegvisomant. After reconstitution with 

1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant. 
- SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant. After reconstitution with 

1 ml of solvent, 1 ml of the solution contains 25 mg pegvisomant. 
- SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant. After reconstitution with 

1 ml of solvent, 1 ml of the solution contains 30 mg pegvisomant. 
- The other ingredients are glycine, mannitol (E421), disodium phosphate anhydrous and sodium 

dihydrogen phosphate monohydrate (see section 2 “SOMAVERT contains sodium”). 
- The solvent is water for injections. 
 
What SOMAVERT looks like and contents of the pack 
SOMAVERT is presented as a powder and a solvent for injection (either 10 mg, 15 mg, 20 mg, 25 mg 
or 30 mg pegvisomant in a vial and 1 ml of solvent in a pre-filled syringe). Pack sizes of 1 and/or 30. 
Not all pack sizes are marketed. The powder is white and the solvent is clear and colourless. 
 
Marketing Authorisation Holder and Manufacturer: 
 
Marketing Authorisation Holder: 
 
Pfizer Europe MA EEIG 
Boulevard de la Plaine 17 
1050 Bruxelles 
Belgium 
 
Manufacturer: 
 
Pfizer Manufacturing Belgium NV 
Rijksweg 12 
2870 Puurs 
Belgium 
 



 66

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien Luxembourg/Luxemburg
Pfizer S.A./N.V. Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11 Tél/Tel: +32 (0)2 554 62 11
 
България Magyarország 
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft. 
Тел.: +359 2 970 4333 Tel.: + 36 1 488 37 00 
  
Česká republika Malta 
Pfizer, spol. s r.o. Vivian Corporation Ltd. 
Tel: +420 283 004 111 Tel: +356 21344610 
  
Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)10 406 43 01
  
Deutschland Norge
Pfizer Pharma GmbH Pfizer AS
Tel: +49 (0)30 550055 51000 Tlf: +47 67 52 61 00
 
Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H. 
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0
 
Ελλάδα Polska 
PFIZER ΕΛΛΑΣ Α.Ε. Pfizer Polska Sp. z o.o. 
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00 
 
España Portugal
Pfizer S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500
  
France România 
Pfizer  Pfizer România S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0)21 207 28 00
  
Hrvatska Slovenija 
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL, Pfizer, podružnica za 

svetovanje s področja farmacevtske dejavnosti, 
Ljubljana  

Tel: + 385 1 3908 777 Tel: + 386 (0)1 52 11 400
  
Ireland Slovenská republika 
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka 
Tel: 1800 633 363 (toll free) 
+44 (0)1304 616161 

Tel: + 421 2 3355 5500 

 
Ísland Suomi/Finland 
Icepharma hf. Pfizer Oy
Sími: + 354 540 8000 Puh/Tel: +358 (0)9 43 00 40
  



 67

Italia Sverige  
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00
 
Κύπρος United Kingdom
PFIZER ΕΛΛΑΣ Α.Ε. (Cyprus Branch) Pfizer Limited
Τηλ: +357 22 817690 Tel: +44 (0)1304 616161
 
Latvija  
Pfizer Luxembourg SARL filiāle Latvijā 
Tel: +371 670 35 775 
 
Lietuva 
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000 
 
 
 
This leaflet was last revised in <{MM/YYYY}>. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments. 
 
------------------------------------------------------------------------------------------------------------------------------ 



 68

 
INSTRUCTIONS FOR USE 

 
SOMAVERT powder in vial with solvent in a pre-filled syringe 
 
pegvisomant for injection 
For Subcutaneous Injection Only 
single dose vial 
 
SOMAVERT comes in a vial as a white block of powder. You must mix SOMAVERT with a liquid 
(diluent) before you can use it.  
The liquid comes in a pre-filled syringe labeled ‘Solvent for SOMAVERT’.  
Do not use any other liquid to mix with SOMAVERT. 
It is important that you do not try to give yourself or someone else an injection unless you have 
received training from your healthcare provider. 
 
Store the carton(s) of powder vials in the refrigerator at 2°C to 8°C and away from direct sunlight.  
The carton(s) containing the SOMAVERT powder vial(s) may be stored at room temperature up to a 
maximum of 25°C for a single period of up to 30 days. Write the Use by date on the carton including 
day/month/year (up to 30 days from the date removed from the refrigerator). The vial(s) must be 
protected from light. Do not return this medicine to refrigerator. 
 
Discard this medicine if not used by the new Use by date or the expiry date printed on the carton, 
whichever is earlier. 
 
The pre-filled solvent syringe may be stored at room temperature. Keep out of reach of children. 
 
 
1. Things you need 
 
A single SOMAVERT pack containing: 

 A vial of SOMAVERT powder. 
 A pre-filled syringe with solvent. 
 A safety needle. 

You will also need: 
 A cotton ball. 
 An alcohol swab. 
 A suitable sharps container. 

 



 69

 
 
 
2. Getting ready 
 
Before you start: 

 Only mix SOMAVERT and the solvent when you are ready to inject your dose. 
 Remove a single SOMAVERT pack from the refrigerator and allow it to come to room 

temperature naturally in a safe place. 
 Wash your hands with soap and water, and dry thoroughly.  
 Peel open the packaging of the syringe and safety needle to make it easier to pick up each 

item as you prepare for your injection. 
 Do not use the syringe or vial if:   

o they are damaged or faulty;  
o the expiration date has passed;  
o it has been frozen, even if it has now thawed (syringe only). 

 
 
3. Choose injection area 
 

 
 

 Choose a different location within an area for each injection.  
 Avoid bony areas or areas that are bruised, red, sore or hard, or areas that have scars or 

skin conditions.  



 70

 Clean the injection area with the alcohol swab as instructed by your healthcare provider. 
 Allow the injection area to dry. 

 
 
4. Remove vial cap 
 

 
 

 Remove the cap from the vial. 
 Throw the cap away; it is not needed again. 

Caution: Do not let anything touch the vial stopper. 
 
 
5. Remove syringe cap 
 

 
 

 Snap off the syringe cap. It may take more effort to snap off than you might expect. 
 Throw the syringe cap away; it is not needed again. 
 Keep the syringe upright to avoid leakage. 

Caution: Do not let the end of the syringe touch anything when the syringe cap is off. 
 
 



 71

6. Attach safety needle 
 

 
 

 Twist the safety needle firmly onto the syringe as far as it will go. 
 
 
7. Remove needle cover 
 

 
 

 Fold the needle guard out of the way of the needle cover. 
 Carefully pull the needle cover straight off. 
 Throw the needle cover away; it is not needed again. 

Caution: Do not let the needle touch anything. 
 
 



 72

8. Insert needle 
 

 
 

 Push the needle through the centre of vial stopper, as shown. 
 Support the syringe while the needle is in the vial stopper to prevent bending the needle. 

 
 
9. Add liquid 
 

 
 

 Tilt both the vial and syringe at an angle, as shown. 
 Push the plunger rod down slowly until all the liquid has emptied into the vial. 
 Caution: Do not squirt the liquid directly onto the powder, as this creates foam. Foam 

makes the medicine unusable. 
 Do not withdraw the needle yet. 

 
 



 73

10. Swirl vial 
 

 
 

 Support both the syringe and vial in one hand, as shown. 
 Gently swirl the liquid, sliding the vial in a circular motion on a flat surface. 
 Continue swirling the liquid until all the powder has fully dissolved. 

Note: This may take up to 5 minutes. 
 
 
11. Check medicine 
 

 
 

 Keeping the needle in the vial, look carefully at the medicine. It must be clear and free of 
particles. 

 Do not use if: 
o the medicine is cloudy or hazy; 
o the medicine has any colour at all; 
o there are any particles or there is a layer of foam in the vial. 

 
 



 74

12. Reposition needle 
 

 
 

 Turn the vial so that you can see the stopper gap, as shown. 
 Pull the needle down so that the needle tip is at the lowest point in the liquid. This will 

help you to draw off as much liquid as possible. 
 Check that the plunger rod has not moved—if it has, then push it back all the way into the 

syringe. This ensures that all air is removed from the syringe before you draw off the 
dose. 

 
 
13. Draw off dose 
 

 
 

 Slowly pull back the plunger rod to withdraw as much medicine as possible from the vial. 
Note: If you see air in the syringe, tap the barrel to float the bubbles to the top,and then 
gently push the bubbles out into the vial. 

 Pull the needle out of the vial. 
 
 



 75

14. Insert needle 
 

 
 

 Gently pinch the skin at the site of injection.  
 Insert the needle to its full depth into the pinched skin. 

 
 
15. Inject medicine 
 

 
 

 Push the plunger rod down slowly until the barrel is empty. 
Note: Make sure you keep the needle in at full depth. 

 Release the pinched skin and pull the needle straight out. 
 
 



 76

16. Make needle safe 
 

 
 

 Fold the needle guard over the needle. 
 Gently apply pressure using a hard surface to lock the needle guard in place. 

Note: You will hear a click when the needle guard has been locked. 
 
 
17. Dispose 
 

 
 

 The syringe and needle should NEVER be reused. Dispose of the needle and syringe as 
instructed by your doctor, nurse or pharmacist and in accordance with local health and 
safety laws. 

 
 



 77

18. After injection 
 

 
 

 If necessary, use a clean cotton ball and press lightly on the injection area. 
 Do not rub the area. 

 
 
QUESTIONS & ANSWERS 
 
What should I do if anything has accidentally touched the vial stopper? 

 Clean the vial stopper with a fresh alcohol wipe, and leave it to dry completely. If you are 
unable to clean the stopper, do not use the vial. 

 
What should I do with the syringe if it has been dropped? 

 Do not use it—even if it looks undamaged. Dispose of the syringe in the same way as a 
used syringe. You will need a replacement syringe. 

 
How many times can I safely insert the needle into the vial stopper? 

 Once only. Withdrawing and reinserting greatly increases the risk of needle damage, and 
will blunt the needle. This can cause discomfort and increases risk of skin damage and 
infection. There is also a risk you may lose some of the medicine. 

 
Is it OK to shake the vial if the powder is not dissolving? 

 No—never shake the vial. Shaking can destroy the medicine and create foam. The 
powder may take a few minutes to dissolve fully, so continue swirling the vial gently 
until the liquid is completely clear. 

 
How can I tell if there is any foam in the vial? 

• Foam looks like a mass of small bubbles that float as a layer to the top of the liquid. Do 
not inject SOMAVERT if it has foamed. 

 



 78

 
 
How can I prevent the medicine from foaming? 

 Press the plunger very slowly so that the liquid gently runs down the inside of the vial. 
Do not spray the liquid directly onto the powder, as this creates foam. This technique will 
also reduce the swirling time and allow more of the medicine to be drawn off. 

 
I can see some air in the syringe. Is this OK? 

 Tiny air bubbles in the liquid are normal and are safe to inject. However, it is possible to 
accidently draw air into the syringe, which should be removed before injecting. Bubbles 
or air gaps that float to the top of the liquid should be pushed back out into the vial. 

 
Why can’t I get all of the medicine out of the vial? 

 The shape of the vial means that a very small amount of the medicine will be left behind 
in the vial. This is normal. To ensure that only a trace of medicine remains, make sure the 
needle tip is as low as it can be in the vial when drawing off your dose. 

 
What should I do if I have any doubts about my medicine? 

 All questions should be handled by a doctor, nurse or pharmacist familiar with 
SOMAVERT. 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) ANDMANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVEUSE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET