Saizen

Recombinant human growth hormone (somatotropin) 191 residues, MW 22.1 kD, synthesized in E. coli

Saizen - Pharmacology:

hGH binds to the human growth hormone receptor (GHR). Upon binding, hGH causes dimerization of GHR, activation of the GHR-associated JAK2 tyrosine kinase, and tyrosyl phosphorylation of both JAK2 and GHR. These events recruit and/or activate a variety of signaling molecules, including MAP kinases, insulin receptor substrates, phosphatidylinositol 3' phosphate kinase, diacylglycerol, protein kinase C, intracellular calcium, and Stat transcription factors. These signaling molecules contribute to the GH-induced changes in enzymatic activity, transport function, and gene expression that ultimately culminate in changes in growth and metabolism.

Saizen mini report

Saizen NDA
NDA - A product marketed under an approved New Drug Application
Saizen INTRAMUSCULAR; SUBCUTANEOUS
INTRAMUSCULAR; SUBCUTANEOUS
Saizen HUMAN PRESCRIPTION DRUG
HUMAN PRESCRIPTION DRUG
Start - Stop data
START DATA:
1996-Oct-08
Start - Stop data
STOP DATA
not occurred

Saizen for patients

Patients being treated with GH and/or their parents should be informed of the potential benefits and risks associated with treatment. If home use is determined to be desirable by the physician, instructions on appropriate use should be given, including a review of the contents of the Patient Information Insert. This information is intended to aid in the safe and effective administration of the medication. It is not a disclosure of all possible adverse or intended effects.

If home use is prescribed, a puncture-resistant container for the disposal of used syringes and needles should be recommended to the patient. Patients and/or parents should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes.

Saizen Interactions

Excessive glucocorticoid therapy will inhibit the growth-promoting effect of human GH. Patients with ACTH deficiency should have their glucocorticoid-replacement dose carefully adjusted to avoid an inhibitory effect on growth.

The use of Nutropin in patients with chronic renal insufficiency receiving glucocorticoid therapy has not been evaluated. Concomitant glucocorticoid therapy may inhibit the growth-promoting effect of Nutropin. If glucocorticoid replacement is required, the glucocorticoid dose should be carefully adjusted.

There was no evidence in the controlled studies of Nutropins interaction with drugs commonly used in chronic renal insufficiency patients. Limited published data indicate that GH treatment increases cytochrome P450 (CP450) mediated antipyrine clearance in man. These data suggest that GH administration may alter the clearance of compounds known to be metabolized by CP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporin). Careful monitoring is advisable when GH is administered in combination with other drugs known to be metabolized by CP450 liver enzymes.

Saizen Contraindications

Growth hormone should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure. Two placebo-controlled clinical trials in non-growth hormone-deficient adult patients (n = 522) with these conditions revealed a significant increase in mortality (41.9% vs. 19.3%) among somatropin-treated patients (doses 5.3 8 mg/day) compared to those receiving placebo.

Nutropin should not be used for growth promotion in pediatric patients with closed epiphyses.

Nutropin should not be used in patients with active neoplasia. GH therapy should be discontinued if evidence of neoplasia develops.

Nutropin, when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), should not be used in patients with a known sensitivity to benzyl alcohol.

Growth hormone is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, Nutropin is not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

Generic name, Overdose, Half Life Saizen, Food Interactions, Chemical, etc..

Saizen see also

Brand Names containing Somatropin recombinant