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Norditropin 10mg/1.5mL Injection
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Indications & Clinical Uses
- Norditropin 10 mg/1.5 mL (somatropin), a recombinant human growth hormone identical to endogenous growth hormone, is used in children for growth failure due to inadequate secretion of natural growth hormone, and for short stature associated with Noonan syndrome, Turner syndrome, being born small for gestational age without catch-up growth, idiopathic short stature, and growth failure due to Prader-Willi syndrome.
- In adults, it is used as replacement therapy for growth hormone deficiency of childhood or adult onset, confirmed by appropriate testing.
- Norditropin is given as a subcutaneous injection using a prefilled, dial-a-dose pen, self-administered or given by a caregiver at home after training from a healthcare provider, once the dose has been individually set by a specialist in growth or endocrine disorders.
Side Effects
- Common reactions include headache, joint and muscle pain, swelling of the hands, feet or face (fluid retention), upper respiratory infections, fever and ear infections in children; injection-site reactions and loss of fat under the skin can occur if sites are not rotated.
- Norditropin carries two boxed warnings.
- First, in critically ill patients recovering from open-heart or abdominal surgery, multiple trauma, or acute respiratory failure, growth hormone treatment has been linked to increased mortality; it should not be started, or should be stopped, in this setting.
- Second, in children with Prader-Willi syndrome who are severely obese or have unassessed breathing problems such as sleep apnea, sudden deaths have been reported, usually within the first months of treatment.
- Other serious risks include raised pressure in the brain, new-onset or worsened diabetes, and slipped growth-plate injury in the hip.
- Seek urgent care for severe headache, vision changes, breathing difficulty, or hip/knee pain with a limp.
Precautions & Warnings
- Norditropin must not be used in patients with active cancer, in critically ill patients after major surgery or trauma (boxed warning), or in children with Prader-Willi syndrome who are severely obese or have unassessed airway obstruction or sleep apnea (boxed warning), due to reported sudden deaths.
- It is contraindicated with known hypersensitivity to somatropin or benzyl alcohol, active proliferative diabetic eye disease, and in children being treated for growth whose growth plates have closed.
- Blood glucose should be monitored regularly, since somatropin can cause or worsen diabetes; thyroid function should also be checked periodically.
- Regular eye examinations are recommended, especially at treatment start, to detect raised intracranial pressure.
- Injection sites should be rotated to avoid fat loss under the skin.
- Data on use in pregnancy and breastfeeding are limited; treatment should be reviewed with the prescriber if pregnancy occurs.
Avoid Interactions
- Oral estrogen-containing medicines, including hormone replacement therapy and some contraceptive pills, can reduce the effectiveness of Norditropin, so a higher growth hormone dose may be needed; transdermal estrogen does not have the same effect.
- Glucocorticoid ('steroid') medicines such as prednisone or hydrocortisone can blunt Norditropin's growth-promoting effect if the steroid dose is too high, so doses of both are reviewed together.
- Because somatropin can raise blood sugar, doses of insulin or other diabetes medicines may need adjustment after starting or changing Norditropin.
- Somatropin may also alter how the body processes other drugs metabolized by the CYP3A4 liver enzyme, such as some corticosteroids, cyclosporine and anticonvulsants, so levels of these medicines may need monitoring.
- Patients should tell their healthcare provider about all prescription and over-the-counter medicines, particularly steroids, estrogens and diabetes treatments, before starting Norditropin.
References
Frequently Asked Questions
Norditropin (somatropin) is a man-made growth hormone used in children with growth failure from low natural growth hormone, Turner or Noonan syndrome, being born small for gestational age, idiopathic short stature, or Prader-Willi syndrome, and in adults with confirmed growth hormone deficiency.
Norditropin is injected under the skin, usually once daily, using a prefilled dial-a-dose pen. Your endocrinologist sets the exact dose, and you rotate the injection site between the abdomen, thighs, buttocks and upper arm each time to prevent skin dimpling.
Common Norditropin side effects include headache, joint or muscle pain, swelling of the hands or feet, and injection-site reactions. Norditropin carries a boxed warning: in critically ill patients after major surgery or trauma, and in children with Prader-Willi syndrome and severe obesity or unassessed sleep apnea, deaths have occurred.
Avoid starting Norditropin if you are critically ill after major surgery, trauma or respiratory failure, or if a child with Prader-Willi syndrome has not had breathing and weight assessed, since sudden deaths have occurred. Tell your provider about oral estrogens and steroids, which can change the dose needed.
If you miss a Norditropin dose, take it as soon as you remember that day; do not double up. Keep unused pens refrigerated at 2°C to 8°C, protected from light. An in-use pen can be kept refrigerated for 4 weeks or at room temperature, up to 25°C, for 3 weeks.
Yes, but only with caution: Norditropin carries a boxed warning that children with Prader-Willi syndrome who are severely obese or have unassessed sleep apnea or airway obstruction have died suddenly during treatment. Your child's breathing and weight must be assessed before starting and monitored throughout.
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