SciTropin A Special Precautions

The maximum recommended daily dose should not be exceeded (see Dosage & Administration).
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates ("gasping syndrome"). The minimum amount of benzyl alcohol at which toxicity may occur is not known.
Hypoadrenalism: Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required. In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses, following initiation of somatropin treatment.
Use with oral oestrogen therapy: If a woman taking somatropin begins oral oestrogen therapy, the dose of somatropin may need to be increased to maintain the serum IGF-1 levels within the normal age-appropriate range. Conversely, if a woman on somatropin discontinues oral oestrogen therapy, the dose of somatropin may need to be reduced to avoid excess of growth hormone and/or side effects.
Insulin Sensitivity: Somatropin may induce a state of insulin resistance and in some patients, hyperglycaemia. Therefore patients should be observed for evidence of glucose intolerance. In rare cases the diagnostic criteria (including obese PWS patients), famile history, steroid treatment, or pre-existing impaired glucose tolerance have been present in most cases where this occurred. In patients with an already manifest diabetes mellitus, the anti-diabetic therapy might require adjustment when somatropin is instituted.
Thyroid Function: During treatment with somatropin, an enhanced T4 to T3 conversion has been found which may result in a reduction in serum T4 and an increase in serum T3concentrations. In general, the peripheral thyroid hormone levels have remained within the reference ranges for healthy subjects. The effects of somatropin on thyroid hormone levels may be of clinical relevance in patients with central subclinical hypothyroidism in whom hypothyroidism theoretically may develop.
Consequently monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism on standard replacement therapy, the potential effect of growth hormone treatment on thyroid function must be closely monitored.
Neoplasms: In growth hormone deficiency secondary to treatment of malignant disease, it is recommended to pay attention to signs of relapse of the malignancy.
Slipped capital femoral epiphysis: In patients with endocrine disorders, including growth hormone deficiency, slipped epiphyses of the hip may occur more frequently than in the general population. Children limping during treatment with somatropin, should be examined clinically.
Benign Intracranial Hypertension (IH): In case of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered and, if appropriate, the growth hormone treatment should be discontinued. At present there is insufficient evidence to give specific advice on the continuation of growth hormone treatment in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Leukaemia: Leukaemia has been reported in a small number of growth hormone deficiency patients, some of whom have been treated with somatropin. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition.
Antibodies: A small percentage of patients may develop antibodies to SciTropin A. SciTropin A has given rise to the formation of antibodies in approximately 1% of patients. The binding capacity of these antibodies is low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in any patient with otherwise unexplained lack of response.
Pancreatitis: Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children.
Scoliosis: Scoliosis is known to be more frequent in some of the patient groups treated with somatropin. In addition, rapid growth in any child can cause progression of scoliosis. Somatropin has not been shown to increase the incidence or severity of scoliosis. Signs of scoliosis should be monitored during treatment.
Acute Critical Illness: The effects of somatropin on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure. Mortality was higher in patients treated with 5.3 or 8 mg somatropin daily compared to patients receiving placebo, 42% vs. 19%. Based on this information, these types of patients should not be treated with somatropin. As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.
In all patients developing other or similar acute critical illness, the possible benefit of treatment with somatropin must be weighed against the potential risk involved.
Prader-Willi syndrome (PWS): In patients with PWS, treatment should always be in combination with a calorie-restricted diet. There have been reports of fatalities associated with the use of growth hormone in paediatric patients with PWS who had one or more of the following risk factors: severe obesity (those patients exceeding a weight/height of 200%), history of respiratory impairment or sleep apnoea or unidentified respiratory infection. Patients with PWS and one or more of these risk factors may be at greater risk.
Patients with PWS should be evaluated for upper airway obstruction, sleep apnoea or respiratory infections before initiation of treatment with somatropin.
If during the evaluation of upper airway obstruction, pathological findings are observed, the child should be referred to an Ear, nose and throat (ENT) specialist for treatment and resolution of the respiratory disorder prior to initiating growth hormone treatment.
Sleep apnoea should be examined by representative methods like polysomnographia or oxymetria during the night before initiation of growth hormone therapy and patients should be monitored if necessary.
All patients with PWS should be evaluated for sleep apnoea and monitored if sleep apnoea is suspected.
All patients with PWS should be monitored for signs of respiratory infections which should be diagnosed as early as possible and treated aggressively.
In patients with severe respiratory disorder treatment with somatropin is contraindicated. If during treatment with somatropin patients show signs of upper airway obstruction (including onset of or increased snoring), treatment should be interrupted, and a new assessment for upper airway obstruction performed.
All patients with PWS should have effective weight control before and during treatment with somatropin.
Experience with prolonged treatment in adults and in patients with PWS is limited.
Patients born SGA: In short children born SGA, other medical reasons or treatments that could explain growth disturbance should be ruled out before starting treatment.
In SGA children it is recommended to measure fasting insulin and blood glucose before start of treatment and annually thereafter. In patients with increased risk for diabetes mellitus (e.g. familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans) oral glucose tolerance testing (OGTT) should be performed. If overt diabetes occurs, growth hormone should not be administered.
In SGA children it is recommended to measure the IGF-I level before start of treatment and twice a year thereafter. If on repeated measurements IGF-I levels exceed +2 SD compared to references for age and pubertal status, the IGF- I/IGFBP-3 ratio could be taken into account to consider dose adjustment.
Experience in initiating treatment in SGA patients near onset of puberty is limited. It is therefore not recommended to initiate treatment near onset of puberty. Experience in patients with Silver-Russell syndrome is limited.
Some of the height gain obtained with treating short children born SGA with growth hormone may be lost if treatment is stopped before final height is reached.
Chronic renal insufficiency: In chronic renal insufficiency (CRI), renal function should be below 50 percent of normal before institution of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of therapy. During this period, conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status) should have been established and should be maintained during treatment.
The treatment should be discontinued at renal transplantation.
To date, no data on final height in patients with chronic renal insufficiency treated with SciTropin A are available.
Benzyl Alcohol: Because of the presence of benzyl alcohol in SciTropin A 5 mg/1.5 mL, the product must not be given to premature babies or neonates. It may cause toxic reactions and anaphylactoid reactions in infants and children up to 2 years old.
Interchangeability/Substitution: Switching of one Somatropin product with another during treatment increases the risk of immunogenic reactions. If such switching is deemed necessary, it should be done with caution under strict medical supervision. No automatic substitution.
Effects on ability to drive and use machines: SciTropin A has no or negligible influence on the ability to drive and use machines.
Use in the Elderly: Experience in patients above 80 years is limited. Elderly patients may be more sensitive to the action of SciTropin A and therefore may be more prone to develop adverse reactions.