Indications for: SKYTROFA
Growth failure in children due to inadequate secretion of endogenous growth hormone (GH).
<1yr (<11.5kg): not established. Give by SC inj into abdomen, buttock, or thigh; rotate inj sites. Individualize and titrate based on response. Weight-based: 0.24mg/kg, given once weekly. ≥1yr (11.5–13.9kg): 3mg/week; (14–16.4kg): 3.6mg/week; (16.5–19.9kg): 4.3mg/week; (20–23.9kg): 5.2mg/week; (24–28.9kg): 6.3mg/week; (29–34.9kg): 7.6mg/week; (35–41.9kg): 9.1mg/week; (42–50.9kg): 11mg/week; (51–60.4kg): 13.3mg/week; (60.5–69.9kg): 15.2mg/week (2 cartridges of 7.6mg each); (70–84.9kg): 18.2mg/week (2 cartridges of 9.1mg each); (85–100kg): 22mg/week (2 cartridges of 11mg each). Discontinue once epiphyseal fusion has occurred. Switching from daily somatropin therapy: wait at least 8hrs between the last dose of somatropin and the first dose of Skytrofa. Non-weight based: see full labeling.
Acute critical illness after open heart or abdominal surgery, or multiple accidental trauma or those with acute respiratory failure. Closed epiphyses. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in children with Prader-Willi syndrome (PWS).
Increased mortality in those with acute critical illness (see Contraindications). Not for treatment of children with growth failure due to PWS. Increased risk of malignancies; if preexisting, complete treatment prior to Skytrofa initiation; discontinue if there is evidence of recurrent activity. History of GHD secondary to intracranial neoplasm: monitor routinely for tumor progression or recurrence. Monitor for increased growth or malignant changes of preexisting nevi. Diabetes. Obesity. Intracranial hypertension: perform routine funduscopic exam at baseline and periodically thereafter; discontinue if papilledema develops. Hypoadrenalism: monitor for reduced serum cortisol levels. Hypothyroidism. Scoliosis (monitor). Monitor thyroid function, glucose tolerance. May increase serum phosphorous, alkaline phosphatase, parathyroid hormone after therapy. Pregnancy. Nursing mothers.
Growth hormone (GH).
May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. May be antagonized by replacement glucocorticoids; adjust glucocorticoid dose. Concomitant drugs metabolized by CYP450 enzymes; monitor. Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher Skytrofa dose.
Viral infection, pyrexia, cough, nausea, vomiting, hemorrhage, diarrhea, abdominal pain, arthralgia, arthritis; severe hypersensitivity reactions, fluid retention, hyperglycemia, impaired glucose tolerance, intracranial hypertension, hypoadrenalism, slipped capital femoral epiphysis (monitor), pancreatitis, lipoatrophy.
Generic Drug Availability:
Single-dose prefilled cartridges—4 (w. needles); Auto-Injector—1