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Replacement of endogenous GH in adults with GH deficiency (GHD) of either childhood- or adult-onset etiology. Long-term treatment of children with short stature associated with Turner syndrome. Treatment of children with growth failure caused by Prader-Willi syndrome; treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by 2 yr of age. Long-term treatment of children with idiopathic short stature.


Active proliferative or severe nonproliferative diabetic retinopathy; acute critical illness caused by complications following open heart surgery, abdominal surgery, or multiple accidental trauma; acute respiratory failure; closed epiphyses in children when used for growth promotion; Prader-Willi syndrome in children who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment; evidence of tumor activity or active neoplasm; sensitivity to benzyl alcohol or glycerin or M-cresol ( Humatrope diluent); hypersensitivity to any component of the product. Intracranial lesion must be inactive and antitumor therapy complete prior to instituting therapy.

Adverse reactions:

Cardiovascular Hypertension (8%); tachycardia, vasodilatation (1% to less than 10%); dependent edema (1% to less than 5%). CNS Headache (18%); paresthesia (17%); dizziness, hypoesthesia (7%); asthenia, fatigue, hypesthesia (6%); insomnia, phantom pain (1% to less than 10%); anorexia, anxiety, hypertonia, somnolence, peripheral neuropathy (1% to less than 5%); intracranial hypertension; intracranial tumors, particularly meningiomas; malaise. Dermatologic Acne (6%); alopecia, bullous eruption, skin disorder (1% to less than 10%); maculopapular rash, rash, verruca (1% to less than 5%); growth of existing nevi (rare); pruritus. EENT Otitis media (86%); ear disorders (18%); pharyngitis (14%); visual field defect (1% to less than 10%); conjunctivitis (1% to less than 5%); diabetic retinopathy, ear or hearing symptoms. GI Nausea (9%); gastroenteritis (8%); melena, mouth disorder, rectal hemorrhage, steatorrhea (1% to less than 10%); abdominal pain, constipation, dyspepsia, vomiting (1% to less than 5%); acute pancreatitis, dry mouth, flatulence, hemorrhoids, pancreatitis in children, tenesmus. Genitourinary Gynecomastia (8%); gastritis (6%); abnormal urine, breast enlargement, dysuria, UTI, vaginal fungal infection (1% to less than 10%); male breast neoplasm, renal calculus (1% to less than 5%); female breast pain; gynecomastia in children. Hematologic-Lymphatic Eosinophilia (12%); decreased prothrombin, purpura (1% to less than 10%); lymphadenopathy (1% to less than 5%); leukemia. Local Injection-site inflammation, injection-site pain (1% to less than 10%); lipoatrophy, rash. Metabolic-Nutritional Hypothyroidism (16%); hyperlipidemia (8%); abnormal glucose tolerance (6%); hypertriglyceridemia (5%); hypomagnesemia (1% to less than 10%); hyperglycemia, periorbital edema (1% to less than 5%); dehydration, fluid retention. Musculoskeletal Arthralgia (36%); myalgia (30%); arthralgia and joint disorders (27%); scoliosis (19%); pain in the extremities (15%); arthrosis, back pain, skeletal pain (11%); stiffness in the extremities (8%); leg pain (5%); hip pain (3%); arthropathy, bursitis, cramps (1% to less than 10%); carpal tunnel syndrome, musculoskeletal pain, rigors (1% to less than 5%); progression of preexisting scoliosis in children. Respiratory Upper respiratory tract infection (16%); rhinitis (14%); bronchitis (9%); bronchospasm, dyspnea (7%); increased cough, respiratory disorder (6%); respiratory tract infection (1% to less than 10%); pneumonia, sinusitis (1% to less than 5%). Miscellaneous Surgical procedures (45%); peripheral edema (42%); edema (41%); flu-like symptoms (23%); peripheral swelling (18%); leg edema (15%); pain (14%); infection (13%); increased nevi (11%); hematoma (9%); increased sweating (8%); generalized edema (6%); fungal infection, periorbital edema (1% to less than 10%); accident, chest pain, face edema, fever, flu-like symptoms, herpes simplex, moniliasis, night sweats, viral infection (1% to less than 5%); bacterial infection; fluid retention, including peripheral swelling; sepsis; slipped capital femoral epiphysis in children; sudden death in children with Prader-Willi syndrome.


Corticosteroids Somatropin may interfere with the metabolic conversion of cortisol and cortisone to their active metabolites. Glucocorticoids may inhibit growth-promoting effects of somatropin. CYP-450 substrates (eg, anticonvulsants, cyclosporine) Somatropin may alter the Cl of drugs metabolized by CYP liver enzymes. Insulin, oral hypoglycemic agents Because somatropin decreases insulin sensitivity, diabetic patients receiving drug therapy may require adjustments in the insulin or oral hypoglycemic dosage when somatropin is started or stopped. Oral estrogens Larger doses of somatropin may be required in women receiving oral estrogens.


Pregnancy Category B Lactation Undetermined. Children Some diluents may contain benzyl alcohol, which can cause gasping syndrome in premature infants. Elderly Elderly patients may be more sensitive to the action of somatropin; therefore, start with a lower dose and smaller dose increments. Acute critical illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, or multiple accidental trauma, and patients with acute respiratory failure have been reported. Administration is contraindicated. Atrophy Tissue atrophy may occur if somatropin is administered subcutaneously at the same site over a long period of time. CV disorders Patients with Turner syndrome are at increased risk for CV disorders (eg, hypertension, stroke). Fatalities Death has been reported in children with Prader-Willi syndrome after starting somatropin. Fluid retention May occur frequently in adult patients receiving somatropin. GHD confirmation Reevaluate patients with epiphyseal closure who were treated with somatropin replacement therapy in childhood before continuing therapy at the reduced dose recommended for GHD adults. Hypothyroidism May develop during therapy; monitor thyroid function. Insulin resistance May be induced with therapy; monitor for glucose intolerance. Intracranial hypertension Intracranial hypertension, with headache, nausea, papilledema, visual changes, or vomiting, has been reported in few patients. Intracranial lesion Frequently examine patients with history of lesion. Laboratory values Serum levels of alkaline phosphatase, IGF-1, inorganic phosphorus, and parathyroid hormone may increase. Otitis media Patients with Turner syndrome are at increased risk of ear and hearing disorders. Progression of scoliosis Progression of preexisting scoliosis can occur in children who experience rapid growth. Slipped capital epiphysis May be seen in children with advanced renal osteodystrophy; may be affected by GH. Be alert to development of limp or complaints of hip or knee pain. Undiagnosed hypothyroidism Undiagnosed or untreated hypothyroidism may prevent an optimal response to somatropin, particularly the growth response in children.



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Consultants Corner

Yaser Habrawi , F.R.C.S.Ed

Yaser Habrawi , F.R.C.S.Ed Consultant Ophthalmologist

Dr. Tahsin Martini

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Dr. Faisal Dibsi

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