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.

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).