Hypersensitivity to growth hormone or any of the excipients;
Closure of epiphyses;
Active malignancy;
Acute critical illness secondary to complications of open heart surgery, abdominal surgery or trauma, or those with acute respiratory failure;
Diabetic retinopathy;
Prader-Willi syndrome with severe obesity, upper airway obstruction, sleep apnea, or severe respiratory impairment (↑ risk of fatal complications);
OB: Pregnancy.
Use Cautiously in:
Growth hormone deficiency due to intracranial lesion;
Pituitary hormone deficiency or hypoadrenalism;
Diabetes (may cause insulin resistance);
Scoliosis (may cause progression);
Turner syndrome with otitis media or cardiovascular disorders (may cause progression);
Thyroid dysfunction;
Lactation: Safety not established in breastfeeding;
Pedi: Contains benzyl alcohol (may cause fatal gasping syndrome in neonates);
Pedi: Childhood cancer survivors (↑ risk of intracranial tumors);
Geri: Appears on Beers list. ↑ risk of edema, arthralgia, carpal tunnel syndrome, gynecomastia, and impaired fasting glucose in older adults. Avoid use in older adults, except for confirmed growth hormone deficiency due to an established etiology.
In patients requiring glucocorticoid/corticosteroid replacement or supplementation, careful titration is required as some metabolic pathways are inhibited by somatropin.
SUBQ (Adults): 0.04 mg/kg/wk divided into equal doses given 7 days per wk initially; may ↑ at 4–8-wk intervals to a maximum of 0.08 mg/kg/wk.
Pediatric Growth Hormone Deficiency
SUBQ (Children): 0.16–0.24 mg/kg/wk divided into equal doses given 6–7 times per wk.
Growth Failure Associated with Prader-Willi or Turner Syndrome
SUBQ (Children): Prader-Willi syndrome: 0.24 mg/kg/wk divided into equal doses given 6–7 times per wk; Turner syndrome: 0.33 mg/kg/wk divided into equal doses given 6–7 times per wk.
Short Stature Born Small for Gestational Age
SUBQ (Children): Up to 0.48 mg/kg/wk divided into equal doses given 6–7 times per wk.
Idiopathic Short Stature
SUBQ (Children): Up to 0.47 mg/kg/wk divided into equal doses given 6–7 times per wk.
Growth Failure: Monitor bone age annually and growth rate determinations, height, and weight every 3–6 mo during therapy.
Lab Test Considerations:
Monitor thyroid function prior to and during therapy. May decrease T4 , radioactive iodine uptake, and thyroxine-binding capacity. Hypothyroidism necessitates concurrent thyroid replacement for growth hormone to be effective. Serum inorganic phosphorus, alkaline phosphatase, and parathyroid hormone may ↑ with somatropin therapy.
Monitor blood glucose periodically during therapy. Patients with diabetes may require ↑ insulin dose.
Monitor for development of neutralizing antibodies if growth rate does not exceed 2.5 cm/6 mo.
Monitor alkaline phosphatase closely in patients with adult growth hormone deficiency.
Instruct patient and parents on correct procedure for reconstituting medication, site selection, technique for SUBQ injection, and disposal of needles and syringes. Review dose schedule. Parents should report persistent pain or edema at injection site.
Explain rationale for prohibition of use for increasing athletic performance. Administration to persons without growth hormone deficiency or after epiphyseal closure may result in acromegaly (coarsening of facial features; enlarged hands, feet, and internal organs; increased blood glucose; hypertension).
Assure parents and child that these dose forms are synthetic and therefore not capable of transmitting Creutzfeldt-Jakob disease, as was the original somatropin, which was extracted from human cadavers.
Advise parents to monitor blood glucose closely in children with diabetes mellitus. Parents should also be advised to report persistent severe abdominal pain (may be a symptom of pancreatitis) and signs and symptoms of hypersensitivity reactions (rash, facial swelling, difficulty breathing) immediately to health care professional.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Emphasize need for regular follow-up with endocrinologist to ensure appropriate growth rate, evaluate lab work, and determine bone age by x-ray exam.
Child's attainment of adult height in growth failure secondary to pituitary growth hormone deficiency. Therapy is limited to period before closure of epiphyseal plates (approximately up to 14–15 yr in girls, 15–16 yr in boys).
Replacement of growth hormone in deficient adults.