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warnings
WARNINGS See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk. There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader‑Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader‑Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If, during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader‑Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively (see CONTRAINDICATIONS ). Unless patients with Prader‑Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin is not indicated for the long‑term treatment of pediatric patients who have growth failure due to genetically confirmed Prader‑Willi syndrome. Benzyl alcohol as a preservative in Bacteriostatic Water for Injection, USP, has been associated with toxicity in newborns. When administering Nutropin to newborns, reconstitute with Sterile Water for Injection, USP. USE ONLY ONE DOSE PER NUTROPIN VIAL AND DISCARD THE UNUSED PORTION.
ADVERSE REACTIONS As with all protein pharmaceuticals, a small percentage of patients may develop antibodies to the protein. GH antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases when binding capacity exceeds 2 mg/L, growth attenuation has been observed. In clinical studies of pediatric patients that were treated with Nutropin for the first time, 0/107 growth hormone–deficient (GHD) patients, 0/125 CRI patients, 0/112 Turner syndrome, and 0/117 ISS patients screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at six months. Additional short‑term immunologic and renal function studies were carried out in a group of patients with CRI after approximately one year of treatment to detect other potential adverse effects of antibodies to GH. Testing included measurements of C1q, C3, C4, rheumatoid factor, creatinine, creatinine clearance, and BUN. No adverse effects of GH antibodies were noted. In addition to an evaluation of compliance with the prescribed treatment program and thyroid status, testing for antibodies to GH should be carried out in any patient who fails to respond to therapy. In a post‑marketing surveillance study, the National Cooperative Growth Study, the pattern of adverse events in over 8000 patients with idiopathic short stature was consistent with the known safety profile of GH, and no new safety signals attributable to GH were identified. The frequency of protocol‑defined targeted adverse events is described in the table, below. Protocol‑Defined Targeted Adverse Events in the ISS NCGS Cohort Reported Events NCGS (N=8018) AVN=avascular necrosis; SCFE=slipped capital femoral epiphysis. Data obtained with several rhGH products (Nutropin, Nutropin AQ, Nutropin Depot and Protropin). Any adverse event Overall 103 (1.3%) Targeted adverse event Overall 103 (1.3%) Injection-site reaction 28 (0.3%) New onset or progression of scoliosis 16 (0.2%) Gynecomastia 12 (0.1%) Any new onset or recurring tumor (benign) 12 (0.1%) Arthralgia or arthritis 10 (0.1%) Diabetes mellitus 5 (0.1%) Edema 5 (0.1%) Cancer, neoplasm (new onset or recurrence) 4(0.0%) Fracture 4(0.0%) Intracranial hypertension 4(0.0%) Abnormal bone or other growth 3(0.0%) Central nervous system tumor 2(0.0%) New or recurrent SCFE or AVN 2(0.0%) Carpal tunnel syndrome 1(0.0%) In studies in patients treated with Nutropin, injection site pain was reported infrequently. Leukemia has been reported in a small number of GHD patients treated with GH. It is uncertain whether this increased risk is related to the pathology of GH deficiency itself, GH therapy, or other associated treatments such as radiation therapy for intracranial tumors. On the basis of current evidence, experts cannot conclude that GH therapy is responsible for these occurrences. The risk to GHD, CRI, or Turner syndrome patients, if any, remains to be established. Other adverse drug reactions that have been reported in GH‑treated patients include the following: 1) Metabolic: mild, transient peripheral edema. In GHD adults, edema or peripheral edema was reported in 41% of GH‑treated patients and 25% of placebo‑treated patients; 2) Musculoskeletal: arthralgias; carpal tunnel syndrome. In GHD adults, arthralgias and other joint disorders were reported in 27% of GH‑treated patients and 15% of placebo‑treated patients; 3) Skin: rare increased growth of pre‑existing nevi; patients should be monitored for malignant transformation; and 4) Endocrine: gynecomastia. Rare pancreatitis.