Indications:

Norditropin^® FlexPro^® (somatropin injection) is indicated in pediatric patients for: 

• The long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency [GHD]). Children below the age of 3 have not been studied in the pivotal clinical studies.
• The treatment of growth disturbance (current height Standard Deviation Score (SDS) < -2) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 standard deviations (SD), who failed to show catch-up growth (Height Velocity SDS < 0 during the last year) by 2 years of age or later.
• The treatment of children with short stature associated with Turner syndrome (TS). Children below the age of 2 were not studied in the primary clinical study.
• The treatment of children with short stature associated with Noonan syndrome (NS). Children below the age of 3 were not studied in the primary clinical study.

Clinical use:

• Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Norditropin^® FlexPro^® in pediatric patients has been established for the above indications.
• Geriatrics (≥65 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.

Contraindications:

• Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. 
• Patients with acute critical illness due to complications following cardiac or abdominal surgery, multiple accident traumas or acute respiratory failure. Clinical studies demonstrated that high doses of growth hormone were associated with a significantly increased morbidity and mortality in those patients.
• Patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment. Norditropin^® is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
• Do not use or discontinue when there is any evidence of neoplastic activity. Anti-tumour therapy should be completed before growth hormone therapy is initiated. 
• Intracranial tumour must be inactive and anti-malignancy treatment must be completed with evidence of remission prior to the institution of growth hormone therapy. 
• Do not use for growth promotion in pediatric patients with closed epiphyses. 
• Do not administer in patients with proliferative or preproliferative diabetic retinopathy. 
• Discontinue at the time of renal transplantation.

Most serious warning and precautions:

• Medical supervision: Treatment with somatropin should be directed by specialists experienced in the diagnosis and management of growth disorders.
• Transfer of growth hormone: Any transfer of growth hormone products should be made cautiously and only under medical supervision. 
• Pediatric patients with Prader-Willi syndrome: There have been reports of fatalities associated with the use of growth hormone in pediatric patients with Prader-Willi syndrome who have one or more of the following risk factors: severe obesity, history of respiratory impairment or sleep apnea or unidentified [i.e., previously undiagnosed/mildly symptomatic] respiratory infections. Monitor patients as required. 

Other relevant warnings and precautions:

• Maximum generally recommended dosage should not be exceeded due to potential risk of side effects.
• It’s recommended that IGF-I concentrations be monitored regularly and maintained within the normal range for age and sex.
• Injection site should be rotated to minimize risk of lipoatrophy.
• Norditropin^® FlexPro^® pre-filled pens should not be used by more than one person.
• Patients with a history of scoliosis who are treated with growth hormone should be monitored for progression of scoliosis.
• Concomitant glucocorticoid therapy should not exceed 10–15 mg hydrocortisone equivalent/m² body surface area during growth hormone therapy.
• Risk of increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure.
• Risk of developing neoplasm.
• Risk of second neoplasm (benign and malignant) in childhood cancer survivors.
• Risk of fluid retention (edema, arthralgia, carpal tunnel syndrome).
• Risk of Type II Diabetes Mellitus in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, a family history of diabetes mellitus.
• Hypothyroidism may develop during treatment. Thyroid function should be evaluated before and assessed during treatment.
• GH therapy can be followed by a transient phase of hypoglycemia, then by an increase in blood glucose levels despite high insulin concentrations.
• Previous undiagnosed central (secondary) hypoadrenalism may be unmasked.
• Unsuspected adrenocorticotropic hormone (ACTH) deficiencies may be unmasked and negate low replacement glucocorticoid doses used in secondary adrenal insufficiencies.
• Risk of local allergic reactions (redness, swelling, pain, inflammation or itching at the site of injection).
• Local and systemic reactions; systemic allergic reactions may rarely occur.
• A small percentage of patients may develop antibodies to GH.
• Intercranial hypertension.
• Intracranial hypertension with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients. Evaluate patients presenting with clinical symptoms.
• Risk of increased tissue turgor (non-edematous swelling, particularly in the hands and feet) and musculoskeletal discomfort (pain, swelling and/or stiffness).
• Risk of pancreatitis in children. Published literature indicates that girls who have Turner syndrome generally may be at greater risk than other growth hormone-treated children. Although rare, pancreatitis should be considered in growth hormone-treated children who develop severe abdominal pain.
• Caution is recommended when administering GH compounds that are metabolized by the CP450 or CY3A4 liver enzymes.
• Patients and/or their parents should be informed about potential advantages and disadvantages of GH therapy including the possible side effects.
• Pediatric patients may develop slipped capital epiphyses more frequently.
• Should be used during pregnancy only if clearly indicated and under medical supervision.
• Use with caution in nursing women.
• Risk of increased serum levels of inorganic phosphorus, alkaline phosphatase, and parathyroid hormone (PTH).
• Bone age should be monitored periodically especially in patients who are pubertal and/or receiving concomitant thyroid replacement therapy.
• Not recommended in patients born SGA who are nearing onset of puberty.
• Risks associated with congenital disorders.
• Inappropriate use of growth hormone by individuals for which growth hormone is not indicated.
• Drug interactions: high doses of androgens, estrogens or anabolic steroids.
• Monitor for Legg-Calvé-Perthes disease in patients with short stature.

For more information:

Please consult the Product Monograph at https://www.novonordisk.ca/content/dam/nncorp/ca/en/products/norditropin-en-product-monograph-13-march-2024.pdf for contraindications, warnings, precautions, adverse reactions, interactions, conditions of clinical use, and dosing information that has not been discussed in this tool.

The Product Monograph is also available by calling us at 1-800-465-4334