Description
Norditropin® is a recombinant human growth hormone (somatropin) produced by recombinant DNA technology. It is indicated for the treatment of growth failure in children due to growth hormone deficiency (GHD), Turner syndrome, Noonan syndrome, idiopathic short stature, and short stature associated with small for gestational age (SGA) with no catch-up growth. In adults, it is indicated for adult-onset or childhood-onset GHD. The NordiFlex® prefilled pen delivers Norditropin via subcutaneous injection, providing precise, easy-to-use, and convenient dosing for home administration.
Fact Table |
Formula | C990H1528N262O300S7 |
License | US FDA, EMA |
Bioavailability | ~81% (subcutaneous) |
Legal status | Rx-only |
Chemical Name | Somatropin (recombinant human growth hormone) |
Elimination half-life | ~2–3 hours (SC); biological activity lasts longer |
Dosage (Strength) | 5 mg/1.5 mL, 10 mg/1.5 mL, 15 mg/1.5 mL prefilled NordiFlex pens (SC) |
Pregnancy | Category C – consult physician |
Brands | Norditropin NordiFlex, Norditropin FlexPro |
Protein binding | Low; binds to GH receptors and plasma proteins |
PubChem CID | 16129663 |
MedlinePlus | a605050 |
ChEBI | 74573 |
ATC code | H01AC01 |
DrugBank | DB00052 |
KEGG | D04466 |
Routes of administration | Subcutaneous injection |
Directions
The dose of Norditropin varies based on indication, patient age, weight, and clinical response:
- Pediatric GHD: 0.024–0.034 mg/kg/day
- Turner syndrome: up to 0.067 mg/kg/day
- Noonan syndrome: up to 0.066 mg/kg/day
- SGA: up to 0.067 mg/kg/day
- Adult GHD: Initiate at 0.2 mg/day (titrate based on IGF-1 levels and tolerability)
Norditropin should be injected subcutaneously into the thigh, buttock, abdomen, or upper arm, rotating injection sites to reduce lipodystrophy.
- Pens should be stored refrigerated before use and can be kept at room temperature (=77°F or 25°C) for up to 21 days after first use.
Ingredients
Each Norditropin NordiFlex pen contains:
- Somatropin (5, 10, 15, or 30 mg/1.5 mL prefilled pen options)
pH is adjusted with hydrochloric acid or sodium hydroxide.
Contraindications
Norditropin is contraindicated in patients with:
- Closed epiphyses in children
- Acute critical illness (e.g., post-surgery, trauma, or respiratory failure)
- Hypersensitivity to somatropin or any excipients
- Proliferative or severe non-proliferative diabetic retinopathy (in adults)
Cautions
- Monitor patients for glucose intolerance, especially those with preexisting diabetes or obesity.
- Increased risk of intracranial hypertension; assess for headaches, visual changes, and vomiting.
- Use with caution in patients with active scoliosis, hypothyroidism, or pancreatitis history.
- Slipped capital femoral epiphysis has been reported in pediatric patients.
- Monitor IGF-1 levels, growth velocity, glucose levels, and thyroid function regularly.
- Long-term safety in patients with a history of cancer or CNS tumors should be carefully considered.
Side Effects
Common side effects include:
Serious adverse effects may include:
- Intracranial hypertension
- New or recurrent malignancy
- Slipped capital femoral epiphysis
- Worsening of preexisting scoliosis
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 12425