Norditropin SimpleXx

• Growth Hormone Deficiency (GHD) in Children:
  For pediatric patients with inadequate endogenous growth hormone secretion causing growth failure.
• Growth Failure Associated with Chronic Renal Insufficiency:
  To promote growth in children with chronic kidney disease prior to renal transplantation.
• Turner Syndrome:
  To improve growth velocity in girls with Turner syndrome.
• Prader-Willi Syndrome:
  For growth failure and body composition improvement.
• Small for Gestational Age (SGA) with Failure to Catch-up Growth:
  Children who fail to catch up in growth by age 2–4 years.
• Idiopathic Short Stature (ISS):
  Short stature without identifiable cause, approved in select regions.
• Adult Growth Hormone Deficiency:
  Replacement therapy in adults with confirmed GHD due to pituitary disease, hypothalamic disease, surgery, radiation, or trauma.
• HIV-associated Wasting or Cachexia:
  To increase lean body mass and weight gain.

Pediatrics (Subcutaneous Injection):

• GHD: 0.025–0.035 mg/kg/day once daily, preferably in the evening.
• Turner Syndrome: 0.045–0.05 mg/kg/day.
• Chronic Renal Insufficiency: 0.05 mg/kg/day.
• Prader-Willi Syndrome: 0.24 mg/kg/week, divided into daily doses.
• Small for Gestational Age: 0.035 mg/kg/day.

Adults:

• Initial dose: 0.15–0.3 mg/day subcutaneously, titrated based on clinical response and IGF-1 levels, generally up to 1.0 mg/day.

Special Populations:

• Renal/Hepatic impairment: No standard dose adjustments, use caution and monitor.
• Elderly: Start with lower doses due to increased sensitivity.

Somatropin is a recombinant human growth hormone identical to endogenous pituitary GH. It binds to GH receptors on target tissues, stimulating production of insulin-like growth factor 1 (IGF-1), primarily in the liver. IGF-1 mediates many anabolic and growth-promoting effects, including increased protein synthesis, cell growth and proliferation, cartilage growth, and bone elongation. It also modulates carbohydrate, fat, and mineral metabolism, promoting linear growth and improved body composition.

• Absorption: Rapidly absorbed after subcutaneous injection; peak plasma concentration in 3–6 hours.
• Distribution: Widely distributed in extracellular fluid; plasma protein binding is low.
• Metabolism: Metabolized primarily by the liver and kidneys through proteolytic degradation.
• Half-life: Approximately 2.5–3 hours after subcutaneous administration.
• Elimination: Metabolites are excreted via urine.

• Pregnancy: No adequate human studies; animal studies show no teratogenicity at therapeutic doses. Use only if potential benefit justifies risk.
• Lactation: Unknown if excreted in human milk. Use with caution during breastfeeding.

• Primary Class: Growth Hormone
• Subclass: Recombinant human somatropin (anabolic hormone replacement)

• Known hypersensitivity to somatropin or any excipients
• Active malignancy or evidence of tumor growth
• Acute critical illness due to complications following surgery, trauma, or respiratory failure
• Proliferative diabetic retinopathy
• Pediatric patients with closed epiphyses
• Severe obesity or Prader-Willi syndrome patients with severe respiratory impairment

• Monitor for intracranial hypertension (symptoms: headache, visual changes) especially in children during initial therapy.
• Assess for glucose intolerance or diabetes mellitus development; monitor blood glucose.
• Regularly evaluate thyroid function; somatropin may induce hypothyroidism.
• Monitor for signs of slipped capital femoral epiphysis or scoliosis progression in children.
• Patients with Prader-Willi syndrome require respiratory monitoring.
• Use cautiously in patients with pre-existing malignancies.

Common:

• Injection site reactions (pain, erythema)
• Edema, joint pain, muscle pain
• Headache
• Carpal tunnel syndrome symptoms
• Mild hyperglycemia

Serious but Rare:

• Intracranial hypertension
• Severe allergic reactions
• Pancreatitis
• Hypothyroidism exacerbation
• Scoliosis progression in children

• Glucocorticoids: May antagonize growth-promoting effects.
• Insulin and Oral Hypoglycemics: Dose adjustment may be required due to altered glucose metabolism.
• Thyroid Hormones: GH may increase conversion of T4 to T3; monitor thyroid function.
• Estrogens: Oral estrogens may reduce GH effectiveness.
• No significant CYP450 involvement.

• Updated pediatric dosing emphasizes individualized titration to IGF-1 targets.
• Guidelines recommend monitoring metabolic parameters (glucose, lipids) during therapy.
• Recent safety reviews stress caution in Prader-Willi syndrome with respiratory compromise.
• FDA and EMA continue approval for all listed indications with emphasis on specialized monitoring.

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze; protect from light.
• Keep in original packaging until use.
• Once reconstituted, some formulations may be stored at room temperature for limited time per manufacturer instructions.