Somavert · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-093362 · has-adverse-reaction-information · PDF-Seite 7

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 to (≥ 1/1 000 to Not Known (≥ 1/10) < 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 7 System

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HOS-093358 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-093357 · has-indication-information · PDF-Seite 3

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.

HOS-093360 · has-interaction-information · PDF-Seite 6

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 1 000 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.

HOS-093361 · has-pregnancy-information · PDF-Seite 6

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 6 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. 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.

HOS-093359 · has-warning-information · PDF-Seite 4

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 As growth hormone-secreting pituitary tumours may sometimes expand, causing serious complications (e.g. visual field defects), it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. 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. 4 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  May treat with SOMAVERT.  Serum concentrations of ALT and AST should be Normal 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.  May treat with SOMAVERT; however, monitor LTs Elevated, but less than or equal to monthly for at least 1 year after initiation of ther

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