Saizen® [somatropin (rDNA origin) for injection]
Saizen® for pediatric growth hormone deficiency was approved in the U.S. in 1996. In 2004, EMD Serono, Inc. received approval from the FDA for treatment of adult growth hormone deficiency for Saizen®.
Pediatric Indication - Saizen® is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Adult Indication - Saizen® is also indicated for use in the treatment of patients with adult growth hormone deficiency (AGHD). The adult indication is for replacement of endogenous growth hormone in adults 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. It is also indicated for patients who were growth hormone deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Saizen® is started.
We are the only company to offer a needle-free drug delivery device for growth hormone. Cool.click®, exclusively for use with Saizen®, lessens the fear and anxiety that patients may experience with needle injections.
One.click® is the first auto-injector pen for growth hormone in the US and allows the insertion of the needle and injection of medication all in one step, with the simple click of a button.
Important Safety Information
Growth hormone (GH) should be used with caution in patients with insulin resistance, glucose intolerance, diabetes, hypothyroidism, intracranial hypertension, and in women who are pregnant or nursing. GH should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment; in the presence of active neoplasia; and in patients with proliferative or preproliferative diabetic retinopathy; or in patients hospitalized with acute critical illness. For more information on Saizen® refer to full prescribing information.
Growth hormone (GH) should be used with caution in patients with insulin resistance, glucose intolerance, diabetes, hypothyroidism, intracranial hypertension, and in women who are pregnant or nursing. GH should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment; in the presence of active neoplasia; and in patients with proliferative or preproliferative diabetic retinopathy; or in patients hospitalized with acute critical illness. For more information on Saizen® refer to full prescribing information.
Full prescribing information (PDF 651 kB)
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