SciTropin A Adverse Reactions

Summary of the safety profile: Patients with growth hormone deficiency are characterised by extracellular volume deficit. When treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse reactions related to fluid retention, such as peripheral oedema, musculoskeletal stiffness, arthralgia, myalgia and paraesthesia are common. In general these adverse reactions are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose-reduction.
The incidence of these undesirable reactions is related to the administered dose, the age of patients, and possibly inversely related to the age of patients at the onset of growth hormone deficiency. In children such adverse reactions are uncommon.
SciTropin A has given rise to the formation of antibodies in approximately 1% of the patients. The binding capacity of these antibodies has been low and no clinical changes have been associated with their formation (see Precautions).
Tabulated list of adverse reactions: Tables 2-7 show the adverse reactions ranked under headings of System Organ Class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data) for each of the indicated conditions.
Clinical trials in children with GHD: (See Table 2.)

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Clinical trials in children with Turner syndrome: (See Table 3.)

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Clinical trials in children with chronic renal insufficiency: (See Table 4.)

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Clinical trials in children with SGA: (See Table 5.)

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Clinical trials in PWS: (See Table 6.)

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Clinical trials in adults with GHD: (See Table 7.)

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Description of selected adverse reactions: Reduced serum cortisol levels: Somatropin has been reported to reduce serum cortisol levels, possibly by affecting carrier proteins or by increased hepatic clearance. The clinical relevance of these findings may be limited. Nevertheless, corticosteroid replacement therapy should be optimised before initiation of therapy.
Prader-Willi syndrome: In the post-marketing experience rare cases of sudden death have been reported in patients affected by Prader-Willi syndrome treated with somatropin, although no causal relationship has been demonstrated.
Leukaemia: Cases of leukaemia (rare or very rare) have been reported in growth hormone deficient children treated with somatropin and included in the post-marketing experience. However, there is no evidence of an increased risk of leukaemia without predisposition factors, such as radiation to the brain or head.
Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease: Slipped capital femoral epiphysis and Legg-Calvé-Perthes disease have been reported in children treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calvé-Perthes is more frequent in case of short stature. But it is unknown if these 2 pathologies are more frequent or not while treated with somatropin. Their diagnosis should be considered in a child with a discomfort or pain in the hip or knee.
Other adverse drug reactions: Other adverse drug reactions may be considered somatropin class effects, such as possible hyperglycaemia caused by decreased insulin sensitivity, decreased free thyroxin level and benign intra-cranial hypertension.