These highlights do not include all the information needed to use Norditropin Cartridges safely and effectively. See full prescribing information for Norditropin Cartridges.
Norditropin ® Cartridges [somatropin (rDNA origin) injection], for subcutaneous use
Initial U.S. Approval: 1987
INDICATIONS AND USAGE
Norditropin is a recombinant human growth hormone indicated for:
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Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), short stature associated with Noonan syndrome, short stature associated with Turner syndrome and short stature born SGA with no catch-up growth by age 2-4 years (1.1)
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Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2)
DOSAGE AND ADMINISTRATION
Norditropin should be administered subcutaneously (2).
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Pediatric GHD: 0.024-0.034 mg/kg/day, 6-7 times a week (2.1)
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Noonan Syndrome: Up to 0.066 mg/kg/day (2.1)
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Turner Syndrome: Up to 0.067 mg/kg/day (2.1)
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SGA: Up to 0.067 mg/kg/day (2.1)
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Adult GHD: 0.004 mg/kg/day to be increased as tolerated to not more than 0.016 mg/kg/day after approximately 6 weeks, or a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day (2.2)
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Norditropin cartridges must be used with their corresponding color-coded NordiPen delivery systems (2.3)
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Injection sites should always be rotated to avoid lipoatrophy (2.3)
DOSAGE FORMS AND STRENGTHS
Norditropin is preloaded in the Norditropin FlexPro or Norditropin NordiFlex pens, or cartridges for use with the corresponding NordiPens (3):
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5 mg/1.5 mL (orange): FlexPro and NordiFlex pens, and cartridges
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10 mg/1.5 mL (blue): FlexPro and NordiFlex pens
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15 mg/1.5 mL (green): FlexPro and NordiFlex pens, and cartridges
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30 mg/3 mL (purple): Norditropin NordiFlex pen only
CONTRAINDICATIONS
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Acute Critical Illness (4.1, 5.1)
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Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment - reports of sudden death (4.2, 5.2)
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Active Malignancy (4.3)
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Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4.4)
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Children with closed epiphyses (4.5)
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Known hypersensitivity to somatropin or excipients (4.6)
WARNINGS AND PRECAUTIONS
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Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1)
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Prader-Willi Syndrome in Children: eva luate for signs of upper airway obstruction and sleep apnea before initiation of treatment for GHD. Discontinue treatment if these signs occur (5.2)
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Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin - in particular meningiomas in patients treated with radiation to the head for their first neoplasm (5.3)
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Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked. Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment (5.4)
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Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5)
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Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome - especially in adults): May occur frequently. Reduce dose as necessary (5.6)
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Hypothyroidism: May first become evident or worsen (5.7)
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Slipped Capital Femoral Epiphysis: May develop. eva luate children with the onset of a limp or hip/knee pain (5.8)
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Progression of Preexisting Scoliosis: May develop (5.9)
ADVERSE REACTIONS
Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.3).
To report SUSPECTED ADVERSE REAC
