Saizen is a recombinant human Growth Hormone produced by genetic engineering using a mammalian cell line.

It is identical in its composition and action of the pituitary human growth hormone – somatropin.

The drug has anabolic and anti-catabolic properties, affecting not only growth but also the metabolic processes.

INDICATIONS

• Adult Patients
  SAIZEN is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
• Adult Onset
  Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
• Childhood Onset
  Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
• Pediatric Patients
  SAIZEN (somatropin) indicates for the treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone.

Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

SIDE EFFECTS

The following important adverse reactions also describes elsewhere in the labeling:

• Progression of preexisting scoliosis in pediatric patients
• Lipoatrophy
• Pancreatitis
• Benzyl alcohol
• Increased mortality in patients with acute critical illness
• Fatalities in children with Prader-Willi syndrome
• Neoplasms
• Glucose intolerance and also diabetes mellitus
• Hypothyroidism
• Slipped capital femoral epiphysis in pediatric patients
• Intracranial hypertension
• Severe hypersensitivity
• Fluid retention and also
• Hypoadrenalism

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