Monograph Details
|
|
Endocrine System
> Pituitary disorders
|
|
NORDITROPIN NORDIFLEX PEN |
| Manufacturer |
|
Novo Nordisk |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Growth hormone (GH). |
| Generic Name |
|
Somatropin (rDNA origin) 5mg, 10mg, 15mg; per 1.5mL prefilled pen; soln for SC inj. |
| Also |
|
• NORDITROPIN
|
| Indications |
|
Growth failure in children due to inadequate endogenous GH secretion. Children with short stature associated with Noonan or Turner syndrome. Adults with childhood-onset or adult-onset GH deficiency. |
| Children |
|
Inject SC into thigh in the evening; rotate sites. Individualize. GH deficient: 0.024–0.034mg/kg per day, 6–7 times/week. Short stature w. Noonan: up to 0.066mg/kg per day. Short stature w. Turner: up to 0.067mg/kg per day. |
| Adults |
|
Inject SC into thigh in the evening; rotate sites. Initially up to max 0.004mg/kg per day; may increase after 6 weeks to max 0.016mg/kg per day. Alternative regimen: see literature. |
| Contraindications |
|
Acute critical illness. Acute respiratory failure. Closed epiphyses. Active malignancy or growing intracranial tumors. Diabetic retinopathy. Prader-Willi syndrome (severely obese or w. respiratory impairment); see literature. |
| Precautions |
|
Monitor gait, thyroid function, glucose tolerance, for malignant transformation of skin lesions, and for intracranial hypertension (do baseline and periodic funduscopic exams). History of intracranial lesions: monitor for lesion progression or recurrence. Prader-Willi syndrome: evaluate baseline respiratory function; monitor weight and for respiratory infection. Discontinue if signs of upper airway obstruction or sleep apnea occurs. Diabetes. Scoliosis. Turner syndrome: evaluate for ear disorders (eg, otitis media); monitor for cardiovascular disorders (eg, stroke, aortic aneurysm/dissection, hypertension). Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
|
Antagonized by glucocorticoids. Antidiabetic medications may need to be adjusted. May affect CYP3A4 substrates. Women on oral estrogen: may need higher somatropin dose. |
| Adverse Reactions |
|
Headache, inj site reactions, localized muscle pain, weakness, hypothyroidism, mild hyperglycemia, glucosuria, arthralgia, myalgia, edema, elevated serum phosphate, antibody formation. Long-term overdose may cause gigantism and/or acromegaly. |
| How Supplied |
Cartridges 5mg, 15mg—1 (use w. NordiPen device)
NordiFlex prefilled Pen—1 |
|
|
|
|
