NORDITROPIN- somatropin injection, solution
Novo Nordisk


1.1 Pediatric Patients

NORDITROPIN is indicated for the treatment of pediatric patients with:

growth failure due to inadequate secretion of endogenous growth hormone (GH),
short stature associated with Noonan syndrome,
short stature associated with Turner syndrome,
short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age,
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,
growth failure due to Prader-Willi syndrome (PWS).

1.2 Adult Patients

NORDITROPIN is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD)


2.1 Administration and Use Instructions

Therapy with NORDITROPIN should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which NORDITROPIN is indicated [see Indications and Usage (1)].
Fundoscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions (5.5)].
Administer NORDITROPIN by subcutaneous injection to the back of the upper arm, abdomen, buttocks, or thigh with regular rotation of injection sites to avoid lipoatrophy.
Inspect visually for particulate matter and discoloration. NORDITROPIN should be clear and colorless. If the solution is cloudy or contains particulate matter do not use.
Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the NORDITROPIN FlexPro prefilled pen.

2.2 Pediatric Dosage

Individualize dosage for each patient based on the growth response.
Divide the calculated weekly NORDITROPIN dosage into equal doses given either 6, or 7 days per week.
The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is:
Pediatric GH Deficiency: 0.17 mg/kg/week to 0.24 mg/kg/week (0.024 to 0.034 mg/kg/day)
Noonan Syndrome: Up to 0.46 mg/kg/week (up to 0.066 mg/kg/day)
Turner Syndrome: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
In very short pediatric patients, HSDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of NORDITROPIN (up to 0.067 mg/kg/day). Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline HSDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed.
Idiopathic Short Stature: Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day)
Prader-Willi Syndrome: 0.24 mg/kg/week (0.034 mg/kg/day)
Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment.
Discontinue NORDITROPIN for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications (4)].

2.3 Adult Dosage

Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults.
Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with NORDITROPIN than younger individuals [see Use in Specific Populations (8.5)].
Estrogen-replete women and patients receiving oral estrogen may require higher doses [see Drug Interactions (7)].
Administer the prescribed dose daily.
Either of two NORDITROPIN dosing regimens may be used:
Non-weight based
Initiate NORDITROPIN with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations.
Decrease the dose as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and gender-specific normal range.
Maintenance dosages will vary considerably from person to person, and between male and female patients.
Initiate NORDITROPIN at 0.004 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily.
Use the patient’s clinical response, adverse reactions, and determination of age- and gender-adjusted serum IGF-1 concentrations as guidance in dose titration.
Not recommended for obese patients as they are more likely to experience adverse reactions with this regimen


NORDITROPIN injection is a clear and colorless solution available as follows:

5 mg in 1.5 mL (orange): NORDITROPIN FlexPro single-patient-use pen
10 mg in 1.5 mL (blue): NORDITROPIN FlexPro single-patient-use pen
15 mg in 1.5 mL (green): NORDITROPIN FlexPro single-patient-use pen
30 mg in 3 mL (purple): NORDITROPIN FlexPro single-patient-use pen


NORDITROPIN 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)].
Hypersensitivity to NORDITROPIN or any of its excipients. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropin products [see Warnings and Precautions (5.6)].
Active proliferative or severe non-proliferative diabetic retinopathy.
Pediatric patients with closed epiphyses.

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