Adverse reactions : תופעות לוואי

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                 Uncommon             Frequency Common             (≥1/100              (≥1/1,000 to <        Not Known (≥1/10)          to <1/10)                 1/100)            (Cannot Be Estimated
From
Available
Data)
Blood and lymphatic                                             thrombocytopenia, system disorders                                                leukopenia, leukocytosis,
haemorrhagic diathesis
Immune system                                                   hypersensitivity          anaphylactic disorders                                                       reactionsb                reactionb, anaphylactoid reactionb
Metabolism and                             hypercholesterola    hypertriglyceridemia nutrition disorders                        emia,
hyperglycaemia,
hypoglycaemia,
weight increased
Psychiatric disorders                      abnormal dreams      panic attack, short       anger term memory loss,
apathy, confusion,
sleep disorder, libido increased


System Organ Class           Very           Common                Uncommon             Frequency Common            (≥1/100             (≥1/1,000 to <        Not Known (≥1/10)         to <1/10)                1/100)            (Cannot Be Estimated
From
Available
Data)
Nervous system            headache      somnolence,          narcolepsy, migraine, disorders                               tremor, dizziness,   dysgeusia hypoaesthesia
Eye disorders                           eye pain             asthenopia Ear and labyrinth                                            Meniere’s disease disorders
Cardiac disorders                       oedema peripheral
Vascular disorders                      hypertension
Respiratory, thoracic                   dyspnoea                                      laryngospasmb and mediastinal disorders
Gastrointestinal          diarrhoea     vomiting,            haemorrhoids, disorders                               constipation,        salivary nausea,              hypersecretion, dry abdominal            mouth, tooth disorder distension,
dyspepsia,
flatulence
Hepatobiliary disorders                 abnormal liver function tests
(e.g. transaminase elevation) (see section 4.4)
Skin and subcutaneous                   hyperhidrosis,       face oedema, dry         angioedemab tissue disorders                        contusion,           skin, increased pruritusb, rashb     tendency to bruise,
night sweats,
erythemab, urticariab
Musculoskeletal and       arthralgia    myalgia, arthritis connective tissue disorders
Renal and urinary                       haematuria           proteinuria, polyuria, disorders                                                    renal impairment General disorders and                   injection site       feeling abnormal, administration site                     reaction             impaired healing, conditions                              (including           hunger injection site hypersensitivity),
injection site bruising or bleeding,
injection site hypertrophy
(e.g. lipohypertro
System Organ Class           Very            Common              Uncommon              Frequency Common             (≥1/100           (≥1/1,000 to <         Not Known (≥1/10)          to <1/10)              1/100)             (Cannot Be Estimated
From
Available
Data) phy)a,
influenza-like illness, fatigue,
asthenia, pyrexia 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, generalised 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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/