FDA label 2330b457-ec1a-4596-b602-5886c5800a40

WARNINGS See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure. The safety of continuing growth hormone 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 growth hormone in patients having acute critical illnesses should be weighed against the potential risk. There have been reports of fatalities after initiating therapy with growth hormone 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 growth hormone. If during treatment with growth hormone, 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 growth hormone 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 ). Nutropin Depot is not indicated for the treatment of short stature in genetically confirmed Prader‑Willi syndrome.

ADVERSE REACTIONS As with all protein pharmaceuticals, 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 who were treated with Nutropin Depot, 0/138 patients with GHD screened for antibody production developed antibodies with binding capacities ≥ 2 mg/L at any time during a treatment period of up to 17.4 months. 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 studies involving 138 pediatric patients treated with Nutropin Depot, the most frequent adverse reactions were injection‑site reactions, which occurred in nearly all patients. On average, 2 to 3 injection‑site adverse reactions were reported per injection. These reactions included nodules (61% of injections), erythema (53%), pain post‑injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%). Adverse reactions observed less frequently in the Nutropin Depot studies which were considered possibly, probably, or definitely related to the drug by the treating physician (usually occurring 1–3 days postdose) included: headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). These symptoms were generally self‑limited and well‑tolerated. One patient experienced a generalized body rash that was most likely an allergic reaction to Nutropin Depot. 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. Other adverse drug reactions that have been reported in GH‑treated patients include the following: 1) Metabolic: mild, transient peripheral edema; 2) Musculoskeletal: arthralgia, carpal tunnel syndrome; 3) Skin: rare increased growth of pre‑existing nevi; patients should be monitored for malignant transformation; 4) Endocrine: gynecomastia; and 5) Rare pancreatitis. Of these reactions, only edema (< 1% of patients) and arthralgia (4%) were reported as related to drug in the Nutropin Depot studies.