Pituitary disorders:

Indications for: SKYTROFA

Growth failure in children due to inadequate secretion of endogenous growth hormone (GH).

Adult Dosage:

Not applicable.

Children Dosage:

<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.

SKYTROFA Contraindications:

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).

SKYTROFA Warnings/Precautions:

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.

SKYTROFA Classification:

Growth hormone (GH).

SKYTROFA Interactions:

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.

Adverse Reactions:

Viral infection, pyrexia, cough, nausea, vomiting, hemorrhage, diarrhea, abdominal pain, arthralgia, arthritis; hypersensitivity reactions (may be severe), fluid retention, hyperglycemia, impaired glucose tolerance, intracranial hypertension, hypoadrenalism, slipped capital femoral epiphysis (monitor), pancreatitis, lipoatrophy.

Generic Drug Availability:

NO

How Supplied:

Single-dose prefilled cartridges—4 (w. needles); Auto-Injector—1

Pricing for SKYTROFA

3mg carton (Qty: 1)
Appx. price $2684
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