Genotropin

Genotropin Adverse Reactions

somatropin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Patients with growth hormone deficiency are characterized by extracellular volume deficit. When treatment with somatropin is started, this deficit is rapidly corrected. In general, in adult patients, adverse effects related to fluid retention, such as edema peripheral, face edema, musculoskeletal stiffness, arthralgia, myalgia and paresthesia are mild to moderate, arise within the first months of treatment, and subside spontaneously or with dose-reduction.
The incidence of these adverse effects is related to the administered dose, the age of the patients, and possibly inversely related to the age of the patients at the onset of growth hormone deficiency.
Tabulated list of adverse reactions: Tables 3-5 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. (See Tables 3, 4 and 5).

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Transient injection site reactions in children have been reported.
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 optimized before initiation of Genotropin therapy.
Rare cases of leukemia have been reported in growth hormone deficient children treated with somatropin, but the incidence appears to be similar to that in children without growth hormone deficiency.
Slipped capital femoral epiphysis and Legg-Calve-Perthes disease have been reported in children treated with growth hormone. But, it is unknown if these 2 pathologies are more frequent or not while treated with somatropin.
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