HUMATROPE
Somatropin · KIT · Eli Lilly and Company
HUMATROPE is a kit containing somatropin, taken intramuscular. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- HUMATROPE
- Generic Name
- Somatropin
- NDC Code (Product)
0002-8148- Manufacturer
- Eli Lilly and Company
- Dosage Form
- KIT
- Route
- INTRAMUSCULAR, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA019640
- Marketing Start
- 01/27/2006
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HUMATROPE is a recombinant human growth hormone indicated for: Pediatric Patients: growth failure due to inadequate secretion of endogenous growth hormone (GH); short stature associated with Turner syndrome; Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age. ( 1.1 ) Adult Patients: replacement of endogenous GH in adults with GH deficiency. ( 1.2 ) 1.1 Pediatric Patients HUMATROPE is indicated for the treatment of pediatric patients with: growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, short stature…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites. ( 2.1 ) Pediatric Dosage - divide the calculated weekly dosage into equal doses given either 6, or 7 days per week. GHD: 0.18 mg/kg/week to 0.3 mg/kg/week. ( 2.2 ) Turner Syndrome: Up to 0.375 mg/kg/week. ( 2.2 ) ISS: Up to 0.37 mg/kg/week. ( 2.2 ) SHOX Deficiency: 0.35 mg/kg/week. ( 2.2 ) SGA: Up to 0.47 mg/kg/week. ( 2.2 ) Adult Dosage - Either of the following two dosing regimens may be used: Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range: 0.15 mg/day-0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day-0.2 mg/day, according to individual patient requirements ( 2.3 ) Weight-based dosing (Not recommended for obese patients): Initiate at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily ( 2.3 ) See Full Prescribing Information for reconstitution instructions. ( 2.4 ) 2.1 Administration and Use Instructions Therapy with HUMATROPE should be supervised by a physician who is experienced…
Contraindications
4 CONTRAINDICATIONS HUMATROPE is contraindicated in patients with: Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions ( 5.1 )] . Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions ( 5.2 )] . Active malignancy [see Warnings and Precautions ( 5.3 )] . Known hypersensitivity to somatropin or any of the excipients in HUMATROPE. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions ( 5.6 )] . Active proliferative or severe non-proliferative diabetic retinopathy. Pediatric patients with closed epiphyses. Acute critical illness. ( 4 ) Pediatric patients with Prader-Willi syndrome who are severely obese, have history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death. ( 4 ) Active malignancy…
Drug Interactions
7 DRUG INTERACTIONS Table 8 includes a list of drugs with clinically important drug interactions when administered concomitantly with HUMATROPE and instructions for preventing or managing them. Table 8: Clinically Important Drug Interactions with HUMATROPE Replacement Glucocorticoid Treatment Clinical Impact: 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. HUMATROPE inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of HUMATROPE may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE [see Warnings and Precautions ( 5.8 )]. Examples: Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Non-Replacement Glucocorticoid Treatment in Pediatric Patient…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are also described elsewhere in the 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 )] Pancreatitis [see Warnings and Precautions ( 5.12 )] Lipoatrophy [see Warnings and Precautions ( 5.13 )] Common adverse reactions reported in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, mya…
Frequently Asked Questions
What is HUMATROPE used for?
HUMATROPE contains Somatropin. It is a kit taken intramuscular. Consult your doctor for specific uses.
Is HUMATROPE a controlled substance?
HUMATROPE is not classified as a controlled substance by the DEA.
What is the generic name for HUMATROPE?
The generic name for HUMATROPE is Somatropin. There are 11 other brand versions of Somatropin.
What is the NDC code for HUMATROPE ?
The NDC (National Drug Code) for HUMATROPE is 0002-8148, listed by Eli Lilly and Company.