Omnitrope 5 mg/1.5mL
Somatropin · INJECTION, SOLUTION · Sandoz Inc
Omnitrope is a injection, solution containing somatropin at 5 mg/1.5mL, taken subcutaneous. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Omnitrope
- Generic Name
- Somatropin
- NDC Code (Product)
0781-3001- Manufacturer
- Sandoz Inc
- Strength
- 5 mg/1.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA021426
- Drug Class
- Recombinant Human Growth Hormone [EPC]
- Marketing Start
- 05/30/2006
Recall History
Western Drug
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE OMNITROPE is a recombinant human growth hormone indicated for: • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature ( 1.1 ) • Adult: Treatment of adults with either adult onset or childhood onset GHD ( 1.2 ) 1.1 Pediatric Patients OMNITROPE is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). OMNITROPE is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )] . OMNITROPE is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years. OMNITROPE is indicated for the treatment of growth failure associated with Turner Syndrome. OMNITROPE is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height stan…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The weekly dose should be divided over 6 or 7 days of subcutaneous injections. Therapy with OMNITROPE should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with GHD, Prader-Willi Syndrome (PWS), Turner Syndrome (TS), those who were born small for gestational age (SGA), Idiopathic Short Stature (ISS) and adult patients with either childhood onset or adult onset GHD. OMNITROPE should be administered subcutaneously ( 2 ). • Pediatric GHD: 0.16 to 0.24 mg/kg/week, divided into 6 to 7 daily injections ( 2.1 ) • Prader-Willi Syndrome: 0.24 mg/kg/week, divided into 6 to 7 daily injections ( 2.1 ) • Small for Gestational Age: Up to 0.48 mg/kg/week, divided into 6 to 7 daily injections ( 2.1 ) • Turner Syndrome: 0.33 mg/kg/week, divided into 6 to 7 daily injections ( 2.1 ) • Idiopathic Short Stature: Up to 0.47 mg/kg/week, divided into 6 to 7 daily injections ( 2.1 ) • Adult GHD: not more than 0.04 mg/kg/week (divided into daily injections) to be increased as tolerated to not more than 0.08 mg/kg/week; to be increased gradually every 1 to 2 months ( 2.2 ) • OMNITROPE Cartridges 5…
Contraindications
4 CONTRAINDICATIONS OMNITROPE is contraindicated in patients with: • Acute Critical Illness Treatment with pharmacologic amounts of somatropin is contraindicated in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure [see Warnings and Precautions ( 5.1 )] . • Prader-Willi Syndrome in Children Somatropin is contraindicated in patients with Prader-Willi Syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions ( 5.2 )] . • Active Malignancy In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin. Somatropin should be discontinued if there is evidence of recurrent activity. Since GHD may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors should be ruled out prior to initiation …
Drug Interactions
7 DRUG INTERACTIONS • 11β-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses ( 7.1 , 7.2 ) • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Should be carefully adjusted ( 7.2 ) • Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin ( 7.3 ) • Oral Estrogen: Larger doses of somatropin may be required in women ( 7.4 ) • Insulin and/or Oral Hypoglycemic Agents: May require adjustment ( 7.5 ) 7.1 11β-Hydroxysteroid Dehydrogenase Type 1 (11βHSD-1) The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH and somatropin inhibit 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. As a consequence, previously undiagnosed central (seconda…
Adverse Reactions
6 ADVERSE REACTIONS Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy ( 6.1 ) and headaches ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch The following important adverse reactions are also described elsewhere in labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )] • Fatalities in children with Prader-Willi Syndrome [see Warnings and Precautions ( 5.2 )] • Neoplasms [see Warnings and Precautions ( 5.3 )] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )] • Intracranial hypertension [see Warnings and Precautions ( 5.5 )] • Severe hypersensitivity [see Warnings and Precautions ( 5.6 )] • Fluid retention [see Warnings and Precautions ( 5.7 )] • Hypoadrenalism [see Warnings and Precautions ( 5.8 )] • Hypothyroidism [see Warnings and Precautions ( 5.9 )] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.10 )] • Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions ( 5.11 )] …
Frequently Asked Questions
What is Omnitrope used for?
Omnitrope contains Somatropin. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Omnitrope a controlled substance?
Omnitrope is not classified as a controlled substance by the DEA.
What is the generic name for Omnitrope?
The generic name for Omnitrope is Somatropin. There are 12 other brand versions of Somatropin.
What is the NDC code for Omnitrope 5 mg/1.5mL?
The NDC (National Drug Code) for Omnitrope 5 mg/1.5mL is 0781-3001, listed by Sandoz Inc.