PredniSONE may enhance the therapeutic effect of Somatropin.
Cortisone may diminish the therapeutic effect of Somatropin. Premature mortality due to cardiovascular disease in hypopituitarism. Rotate administration sites (back of upper arm, abdomen, buttock, or thigh) to avoid tissue atrophy.Cartridge: Store at 2°C to 8°C (36°F to 46°F); do not freeze.
Cardiovascular: Peripheral edema (≤69%), facial edema (≤50%), edema (adults: ≤41%; children: ≤3%), lower extremity edema (adults: ≤15%)Central nervous system: Pain (≤19%), hypoesthesia (≤15%), headache (adults: ≤18%; children: ≤7%), paresthesia (≤13%)Endocrine & metabolic: Hypothyroidism (children: ≤16%; adults: ≤5%), elevated glycosylated hemoglobin (children: ≤14%), eosinophilia (children: ≤12%)Gastrointestinal: Nausea (≤13%), flatulence (≤25%), abdominal pain (≤25%), vomiting (≤19%)Immunologic: Antibody development (children: ≤24%; binding capacity ≥0.02 mg/mL: 2%; binding capacity >2 mg/mL: <1%)Local: Pain at injection site (≤31%), injection site reaction (≤19%)Neuromuscular & skeletal: Arthralgia (≤44%), arthropathy (adults: ≤27%; children: 11%), myalgia (≤30%), scoliosis (children: ≤19%; exacerbation or new), limb pain (4% to 19%), swelling of extremities (18%), ostealgia (adults: ≤11%)Respiratory: Upper respiratory tract infection (≤16%)Cardiovascular: Chest pain (adults: ≤5%), hypertension (≤8%)Central nervous system: Fatigue (6% to 9%), nipple pain (≤6%), depression (adults: ≤5%), insomnia (adults: ≤5%), carpal tunnel syndrome (1% to <5%), sleep apnea (adults)Dermatologic: Diaphoresis (≤8%), melanocytic nevus (≤2%)Endocrine & metabolic: Impaired glucose tolerance/prediabetes (10%), hyperglycemia (1% to 9%), hyperlipidemia (children: ≤8%), gynecomastia (≤6%), dependent edema (adults: ≤5%), diabetes mellitus (≤5%; includes exacerbation and new-onset), hypertriglyceridemia (≤5%), fluid retention (3% to 5%)Genitourinary: Breast hypertrophy (≤6%), breast neoplasm (≤6%), breast swelling (≤6%), breast tenderness (≤6%), mastalgia (≤6%), urinary tract infection (children: ≤3%)Neuromuscular & skeletal: Stiffness (adults: ≤8%; includes extremities and musculoskeletal), joint stiffness (4% to 8%), joint swelling (5% to 6%), lower extremity pain (children: ≤5%), arthralgia of hip (children: ≤3%), tonsillitis (children: ≤3%), abnormal bone growth (children: ≤2%; including disproportional growth of lower jaw)Respiratory: Bronchitis (9%), flu-like symptoms (≤8%), sinusitis (children: ≤3%), dyspnea (adults)Central nervous system: Aggressive behavior (children), seizure (children)Dermatologic: Alopecia (children), exacerbation of psoriasis (children), rash at injection site (children)Endocrine & metabolic: Fluid volume disorder (children), glycosuria (adults), hypoglycemia (children)Local: Bleeding at injection site (children), burning sensation at injection site (children), erythema at injection site (children), fibrosis at injection site (children), inflammation at injection site (children), injection site nodule (children), injection site numbness (children), local skin hyperpigmentation (children; injection site), swelling at injection site (children)Neuromuscular & skeletal: Asthenia (adults), lipoatrophy (children), musculoskeletal disease (discomfort)<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, arthritis, avascular necrosis of femoral head (Legg-Calve-Perthes disease), benign neoplasm (children; new or recurring), bone fracture, brain neoplasm, cardiac disease, CNS neoplasm (children), decreased T4, diabetic coma, diabetic ketoacidosis, diabetic retinopathy, hypersensitivity reaction, illness (acute critical), increased serum alkaline phosphatase, intracranial hypertension (includes benign intracranial hypertension in children), leukemia, malignant neoplasm (includes new or recurring), nerve compression, pancreatitis, papilledema, precocious puberty, slipped capital femoral epiphysis, visual disturbance• Fluid retention: Fluid retention may occur in adults; manifestations of fluid retention (eg, edema, arthralgia, myalgia, nerve compression syndromes [including carpal tunnel syndrome]/paresthesias) are generally transient and dose dependent.
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