Peptide education
Somatropin
Recombinant human growth hormone · rhGH · Norditropin · Serostim
Somatropin is recombinant human growth hormone. US prescription products include Norditropin, used for certain growth disorders and growth hormone deficiency, and Serostim, used for HIV-associated wasting or cachexia in adults.
Somatropin has established medical uses, but the diagnosis and product matter. Norditropin and Serostim treat different populations and use different dosing.
Overview
Quick answer
A hormone replacement medicine is not the same as a drug that stimulates the body to release growth hormone. Somatropin products also have different labeled indications, doses and instructions; a use listed for Serostim should not be assumed to appear on the Norditropin label.
What is Norditropin used for?
Its US label covers adult growth hormone deficiency and pediatric growth failure from growth hormone deficiency, Prader-Willi syndrome, Noonan syndrome and other specified causes of short stature.
What is Serostim used for?
Serostim is labeled for adults with HIV and wasting or cachexia to increase lean body mass and body weight and improve physical endurance. Concomitant antiretroviral therapy is required.
How is somatropin given?
Both cited products are injected under the skin. Norditropin pediatric doses are calculated weekly and divided over six or seven days; adult dosing is individualized. Serostim uses a separate weight-based schedule.
What are the main risks?
Risks include fluid retention, impaired glucose tolerance, intracranial hypertension and tumor-related concerns. Certain critical illnesses, active malignancy, and active proliferative or severe non-proliferative diabetic retinopathy are contraindications. Norditropin is also contraindicated in children with Prader-Willi syndrome and specified obesity or respiratory risk factors.
Evidence
Evidence snapshot
The Norditropin label describes a randomized dose-response study in 111 previously untreated children with growth hormone deficiency.
A multicenter trial recruited 166 participants with growth hormone deficiency and assessed IGF-1, body composition and quality of life during replacement.
The Serostim label describes placebo-controlled trials of body weight, lean body mass and physical work output in patients receiving antiretroviral therapy.
Glucose intolerance, fluid retention and growth hormone class warnings can affect treatment decisions.
Claims
Common claims vs evidence
| Claim | Human evidence | Verdict |
|---|---|---|
| Somatropin can treat growth hormone deficiency. | Norditropin's label includes pediatric and adult growth hormone deficiency. Clinical studies measured growth in children and metabolic outcomes in adults. | Supported for the product's labeled populations. |
| Every somatropin product has the same approved uses. | Norditropin and Serostim labels cover different indications and describe different doses, despite containing the same active hormone. | No. The product-specific label determines its approved uses. |
| Body-composition findings in adults with GHD prove a general wellness benefit. | The adult replacement trial enrolled people with diagnosed growth hormone deficiency. It did not study general anti-aging or athletic use in healthy adults. | The study does not establish that broader claim. |
Bottom line
Main takeaway
Somatropin replaces or supplies growth hormone in specific medical conditions.
Norditropin and Serostim have different indications and dosing instructions.
Pediatric growth velocity, adult body composition and HIV-associated wasting are distinct outcomes in distinct populations.
Identity
What it is
Somatropin is a recombinant 191-amino-acid form of human growth hormone.
Growth hormone acts directly and through IGF-1. Effects include growth in children with open growth plates and changes in metabolism.
Use context
Routes, doses, and cycle patterns
Doses depend on the product, indication, response and clinical circumstances.
Human studies and product labels
Norditropin for pediatric growth hormone deficiency
- Purpose
- Treatment of growth failure due to inadequate growth hormone secretion
- Context
- US prescribing information
- Route
- Subcutaneous injection
- Amount
- 0.17 to 0.24 mg/kg per week
- Frequency
- Weekly total divided into equal doses on 6 or 7 days
Other pediatric indications have different label doses; treatment is individualized to growth response.
Norditropin for adult growth hormone deficiency
- Purpose
- Growth hormone replacement
- Context
- US prescribing information, non-weight-based option
- Route
- Subcutaneous injection
- Amount
- Approximately 0.2 mg per day initially
- Frequency
- Daily, with gradual response-based adjustment
The label gives an initial range of 0.15 to 0.3 mg per day and also describes a weight-based option. Age, estrogen use, response and adverse effects affect dosing.
Serostim for HIV-associated wasting or cachexia
- Purpose
- Increase lean body mass and body weight and improve physical endurance
- Context
- US prescribing information
- Route
- Subcutaneous injection
- Amount
- Approximately 0.1 mg/kg, up to 6 mg
- Frequency
- Usual starting schedule is once daily at bedtime
The label uses fixed-dose weight bands for most patients and describes 0.1 mg/kg every other day as a starting option for those at increased risk of adverse effects, such as glucose intolerance. Concomitant antiretroviral therapy is necessary; preparation instructions are product-specific.
Research
Research evidence
The Norditropin label reports pediatric growth studies, while a separate randomized trial examined replacement in adults with GHD. Serostim's trials addressed HIV-associated wasting, a different indication.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| Norditropin pediatric GHD dose-response study | 111 previously untreated children with growth hormone deficiency | Randomized open-label study of three doses over two years | Daily subcutaneous Norditropin | Adjusted mean height standard deviation score rose by 0.81, 1.57 and 1.73 across ascending dose groups. | There was no untreated control group; higher research doses are not the routine labeled starting dose. | Randomized dose comparison |
| Adult growth hormone deficiency trial | 166 recruited participants aged 17 to 67 with growth hormone deficiency | Double-blind placebo-controlled trial for six months, then active treatment | Recombinant human growth hormone replacement | Fat-free mass rose and fat mass fell; fluid-retention symptoms were reported by 48% on growth hormone and 30% on placebo during the initial six months. | The initial placebo comparison was six months and used an older weight-based regimen. | Randomized, deficiency-specific |
| Serostim wasting studies | People with HIV-associated wasting receiving antiretroviral treatment | Placebo-controlled trials summarized in the US label | Serostim subcutaneous injection | Studies assessed body weight, lean body mass and physical work output. | These outcomes do not establish survival benefit or a general indication for body-composition changes. | Controlled, indication-specific |
Cautions
Safety and unknowns
- The labels contraindicate use in specified acute critical illness, active malignancy, and active proliferative or severe non-proliferative diabetic retinopathy. Somatropin can decrease insulin sensitivity and raise blood glucose.
- Fluid retention can cause swelling, joint or muscle discomfort and carpal tunnel symptoms. Intracranial hypertension and serious hypersensitivity are also described.
- Norditropin is contraindicated in children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment because of the risk of sudden death. Its label calls for assessment of airway obstruction and sleep apnea before treatment.
- Children receiving growth hormone need evaluation for hip or knee pain and limping because slipped capital femoral epiphysis can occur.
Mechanism
How it is proposed to work
Somatropin acts at growth hormone receptors and increases IGF-1, a signal involved in growth and metabolism.
The effects of growth hormone include changes in protein, carbohydrate and fat metabolism.
Details
Technical details
Sources
References
- 1.
DailyMed. Norditropin prescribing information
US label for pediatric growth indications and adult growth hormone deficiency, dosing, studies and warnings.
- 2.
DailyMed. Serostim prescribing information
US label and trial summaries for adults with HIV-associated wasting or cachexia.
- 3.
PubMed. The Australian multicenter trial of growth hormone treatment in GH-deficient adults
doi:10.1210/jcem.83.1.4482 PMID:9435425
Randomized placebo-controlled trial of recombinant growth hormone in adults with growth hormone deficiency.