ACCRETROPIN SIDE EFFECTS

SIDE EFFECTS

As with all protein pharmaceuticals, some patients may develop antibodies to the protein. Over 3 years of Accretropin™ (somatropin injection) therapy, no patient with growth hormone deficiency or Turner syndrome developed anti-GH antibodies with binding capacities greater than 0.67 mg/L, which is below the threshold at which attenuation of growth velocity has been observed. Anti-GH antibody titers peaked by 6-12 months and remained stable or declined subsequently. Anti-E.coli antibody titers increased slightly during Accretropin™ (somatropin injection) treatment. No growth attenuation was noted in any patient who developed anti-hGH or anti-E. coli antibodies.

Pediatric Growth Hormone-Deficient Patients

In the clinical study conducted in children with GHD injection site reactions were the most frequent treatment-related adverse event reported in 50% of patients (includes the following descriptions: bruising, erythema, hemorrhage, edema, pain, pruritis, rash, swelling). Other treatment-related adverse events (as assessed by the investigators) with a frequency ≥ 3% were nausea, headache, fatigue, and scoliosis. One patient with pre- existing type-1 diabetes required adjustment of the insulin dose under observation. See also growth hormone associated adverse events under.

Turner Syndrome Patients

In the clinical study conducted in pediatric patients with Turner Syndrome the only treatment-related adverse event (as assessed by the investigators) that occurred in ≥ 3% of patients was injection site reaction which occurred in 32% of patients (includes the following descriptions: erythema, edema, pain, pruritis). See also growth hormone associated adverse events under.