Somatropin
- Atc Codes:H01AC01
- CAS Codes:12629-01-5
- PHARMGKB ID:12629-01-5
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Other genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Belgium: Genotonorn, Humatrope, Norditropin, NutropinAq, Omnitrope, Zomacton; Bulgaria: Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Cyprus: Genotropin, Humatrope, Saizen; Czech Republic: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Denmark: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Zomacton; Estonia: Genotropin, Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Finland: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen; France: Genotonorm, Maxomat, Norditropine, NutropinAq, Omnitrope, Umatrope, Zomacton; Germany: Genotonorm, Genotropin, hGH, Humatrope, Norditropin, Norditropine, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Greece: Genotropin, Humatrope, NeutropinAq, Norditropin, NutropinAq, Omnitrope, Saizen, Zomacton; Hungary: NutropinAq, Omnitrope, Valtropin; Ireland: Genotropin, Norditropin, Omnitrop, Omnitrope, Saizen, Zomacton; Italy: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Zomacton; Latvia: Genotropin, Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Lithuania: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Valtropin, Zomacton; Luxembourg: NutropinAq, Omnitrope, Valtropin; Malta: Genotropin, Humatrope, Norditropin; Netherlands: Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Zomacton; Poland: Genotropin, Humatrope, Norditropin, Omnitrope, Saizen, Valtropin; Portugal: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Romania: Genotropin, Norditropin, NutropinAq, Omnitrope, Valtropin, Zomacton; Slovakia: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Valtropin, Zomacton; Slovenia: Genotropin, Humatrope, Norditropin; Spain: Genotonorm, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Zomacton; Sweden: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Umatrope, Valtropin, Zomacton; UK: Genotropin, Humatrope, Norditropin, NutropinAq, Omnitrope, Saizen, Zomacton.
North America
Canada: Humatrope, Nutropin AQ, Omnitrope, Saizen; USA: Bio-tropin, Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Tev-Tropin, Valtropin, Zorbtive.
Latin America
Argentina: Biotropin, Genotropin, HHT, Hutrope, Norditropin, Saizen; Brazil: Genotropin, Hormotrop, Humatrope, Norditropin, Saizen, Somatrop; Mexico: Cryotropin, Genotropin, Humatrope, Norditropin, Saizen, Serostim.
Asia
Japan: Genotropin, Growject, Humatrope, Norditropin, Saizen, Serostim.
Drug combinations
Chemistry
Somatropin: C~990~H~1528~N~262~O~300~S~7~. Mw: 22124.77. A single polypeptide chain of 191 aa having the normal structure of the principal growth stimulating hormone obtained from the anterior lobe of the human pituitary gland. (1) Growth hormone (human). CAS-12629-01-5 (1977).
Pharmacologic Category
Hormones and Synthetic Substitutes; Pituitary. Growth Hormone. (ATC-Code: H01AC01).
Mechanism of action
A purified polypeptide hormone of recombinant DNA origin. Somatropin contains identical sequence of amino acids found in human growth hormone. Human growth hormone stimulates growth of linear bone, skeletal muscle, and organs. Stimulates erythropoietin, which increases red blood cell mass. Exerts both insulin-like and diabetogenic effects. Enhances transmucosal transport of water, electrolytes, and nutrients across gut.
Therapeutic use
Treatment of growth failure due to inadequate endogenous growth hormone secretion. Treatment of short stature associated with Turner syndrome. Treatment of Prader-Willi syndrome. Treatment of growth failure associated with chronic renal insufficiency up until time of renal transplantation. Treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by 2 years of age or by 2-4 years of age. Treatment of idiopathic short stature (non-growth hormone-deficient short stature) defined by height standard deviation score less than or equal to -2.25 and growth rate not likely to attain normal adult height. Treatment of short stature or growth failure associated with short stature homeobox gene deficiency. Treatment of short stature associated with Noonan syndrome. HIV with wasting or cachexia with concomitant antiviral therapy. Replacement of endogenous growth hormone in adult growth hormone deficiency. Treatment of short-bowel syndrome.
Pregnancy and lactiation implications
Teratogenic effects not observed in animals. During normal pregnancy, maternal production of endogenous growth hormone decreases as placental growth hormone production increases. Data with somatropin use during pregnancy is limited. Excretion in breast milk unknown (use caution).
Unlabeled use
Investigational: Congestive heart failure. Pediatric HIV patients with wasting/cachexia. HIV-associated adipose redistribution syndrome.
Contraindications
Hypersensitivity to growth hormone or any component of the formulation. Growth promotion in pediatric patients with closed epiphyses. Progression of any underlying intracranial lesion or actively growing intracranial tumor. Acute critical illness due to complications following open heart or abdominal surgery. Multiple accidental trauma or acute respiratory failure. Evidence of active malignancy. Active proliferative or severe nonproliferative diabetic retinopathy. Use in Prader-Willi syndrome without growth hormone deficiency or in patients with Prader-Willi syndrome with growth hormone deficiency who are severely obese or have severe respiratory impairment.
Warnings and precautions
Fluid retention may occur frequently in adults during use. Intracranial hypertension (higher risk if Turner syndrome, chronic renal failure, or Prader-Willi syndrome). Use contraindicated with active malignancy. Progression of scoliosis may occur in children experiencing rapid growth. Patients with growth hormone deficiency may develop slipped capital epiphyses more frequently. Initiation of somatropin contraindicated with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure (mortality may be increased; use with caution). Use with caution in diabetes or with risk factors for impaired glucose tolerance (may decrease insulin sensitivity). Untreated/undiagnosed hypothyroidism may decrease response to therapy. Fatalities reported in children with Prader-Willi syndrome following use of growth hormone (higher risk if severe obesity, sleep apnea, respiratory impairment, or unidentified respiratory infection; males may be at greater risk). Treatment interruption recommended in patients who show signs of upper airway obstruction, including onset of, or increased, snoring. Patients with Turner syndrome are at increased risk for otitis media and other ear/hearing disorders, cardiovascular disorders (including stroke, aortic aneurysm, hypertension), and thyroid disease. Concurrent glucocorticoid therapy may inhibit growth promotion effects. Patients with HIV infection should be maintained on antiretroviral therapy to prevent potential increase in viral replication. Products may contain benzyl alcohol, associated with «gasping syndrome» in neonates. Some products may contain m-cresol as preservative. Not for I.V. injection.