TM Owner Sandoz
Omnitrope 5mg Injection
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Indications & Clinical Uses
- Omnitrope 5 mg is an injectable recombinant human growth hormone (somatropin) that is biologically identical to the natural hormone and was one of the first biosimilar/follow-on protein medicines approved.
- It is used to treat growth failure in children caused by inadequate growth hormone production, Turner syndrome, chronic kidney disease, or being born small for gestational age without catch-up growth, and it is also approved for adults with growth hormone deficiency that began in childhood or adulthood.
- In children the aim is to increase growth rate towards a normal adult height; in adults it corrects the metabolic effects of growth hormone deficiency, such as abnormal body composition and low energy.
- Omnitrope is manufactured by Sandoz as a biosimilar referencing the originator somatropin product, Genotropin, and treatment is normally started and monitored by an endocrinologist or paediatric specialist.
Side Effects
- Common side effects of Omnitrope include injection-site reactions such as redness, pain or a small lump, headache, joint and muscle aches, and mild fluid retention causing swelling of the hands or feet, particularly in adults starting treatment.
- Growth hormone can unmask an underactive thyroid or raise blood sugar, so tiredness, weight change, or increased thirst and urination should be reported.
- In children, seek urgent medical attention for severe headache with vomiting and vision changes, which can indicate raised pressure inside the skull (benign intracranial hypertension), for new limping or hip/knee pain, which can signal a slipped growth-plate injury, or for worsening curve of the spine.
- There is no boxed warning on the current somatropin label, but the label does warn against use during acute critical illness because of a reported increase in mortality in that setting.
- Rotate injection sites to reduce skin changes.
Precautions & Warnings
- Omnitrope must not be used by anyone with active cancer, or by patients who are critically ill following open-heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure, because growth hormone has been linked to increased mortality in that setting.
- Growth hormone therapy can worsen pre-existing scoliosis, unmask hidden hypothyroidism, and reduce insulin sensitivity, so thyroid function and blood glucose are checked periodically, along with growth or body composition response.
- Children treated for growth hormone deficiency caused by a brain tumour or who are cancer survivors need monitoring for tumour recurrence or a second cancer.
- Some multidose Omnitrope formulations contain benzyl alcohol and must never be given to premature babies or newborns.
- Treatment should stop once the growth plates have fused in children, and it is not a treatment for normal short stature without confirmed deficiency.
Avoid Interactions
- Corticosteroid medicines such as prednisolone or hydrocortisone can blunt the growth-promoting effect of Omnitrope, so the dose of both medicines may need adjusting if they are used together, particularly in children on replacement steroids for adrenal insufficiency.
- Because growth hormone can reduce insulin sensitivity, people with diabetes may need their insulin or oral diabetes medicine dose reviewed after starting or stopping Omnitrope.
- Growth hormone increases the activity of liver enzymes that break down certain drugs, which can lower blood levels of oestrogen-based contraceptives, anticonvulsants such as carbamazepine, and ciclosporin, so these may need dose changes.
- Anyone starting thyroid hormone replacement or oestrogen therapy while on Omnitrope should have growth hormone dosing reviewed.
- Tell the prescriber about every medicine, including oral contraceptives and steroids, before starting treatment.
References
Frequently Asked Questions
Omnitrope (somatropin) is a growth hormone injection used for children with growth failure from hormone deficiency, Turner syndrome, chronic kidney disease, or being born small for gestational age. It also treats adults with confirmed growth hormone deficiency.
Omnitrope is injected under the skin (subcutaneously), usually once daily in the evening, using a pen device or vial and syringe. The healthcare provider shows you how to rotate injection sites. Doses are based on body weight and response.
Common effects include injection-site reactions, joint or muscle aches, headache, and swelling. Report severe headache with vision changes or vomiting, new hip or knee pain, or signs of high blood sugar promptly, as these need medical review.
Do not use Omnitrope if you have active cancer or are critically ill after major surgery or trauma, as it has been linked to higher death rates in that setting. Tell your provider about steroids, insulin, or contraceptive pills you take.
Your provider will check growth, thyroid function, and blood sugar regularly, and monitor for spine curvature or tumour recurrence in cancer survivors. Children are followed until the growth plates close, since Omnitrope no longer increases height after that.
Yes, treatment usually continues for years until final adult height is reached or the growth plates fuse. Some multidose formulations contain benzyl alcohol and must not be given to premature or newborn babies. Regular specialist follow-up is required throughout.
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