Saizen Special Precautions



PT. Merck Tbk
Full Prescribing Info
Special Precautions
Relative Contraindications: Patients with Down's syndrome, bloom's syndrome, fanconi anemia should not be treated with Saizen.
The bone age must be measured periodically during treatment with Saizen, especially in pubertal patients and/or in patients receiving thyroid substitution therapy, because in these patients, maturation of the epiphyses can proceed rapidly.
In the case of somatropin deficiency secondary to antitumour therapy, it is recommended to look out for possible signs of renewal of the malignant process, even though according to the present state of knowledge, the tumour relapse rate under therapy with somatropin is not increased. If there is evidence of renewal of the malignant process, treatment with Saizen must be stopped.
Patients with growth hormone deficiency due to an intracranial lesion will be examined regularly in order to detect any progression or relapse of a disease.
During substitution therapy in adults, fluid retention is to be expected.
Hypothyroidism: During treatment with Saizen, thyroid levels in the serum may fall as a result of increased peripheral deiodisation from T4 to T3. Hypothyroidism can develop, which if not treated can impair the action of Saizen. Regular testing of the thyroid function is recommended during treatment with Saizen. Hypothyroidism appearing during the treatment with growth hormone must be substituted with the administration of thyroid hormone, in order to obtain an adequate therapeutic effect.
Benign Intracranial Hypertension: In cases of severe or recurrent headaches, visual disorders, nausea and/or vomiting, a fundoscopy is recommended in order to detect a possible papilloedema. If papilloedema is confirmed, a diagnosis of benign intracranial hypertension (or pseudotumor cerebri) has to be considered and if necessary the treatment with Saizen must be stopped. At present, there is insufficient evidence to guide clinical decision making in patients with normalized intracranial hypertension. If the treatment with growth hormone is restarted, the patient must be kept under observation for possible signs of intracranial hypertension.
Insulin Resistance: The administration of growth hormone results in a transient hypoglycemic phase of about 2 hrs. After 2-4 hrs, the blood-sugar level rises in spite of high insulin concentrations.
Somatropin can induce insulin resistance, which can lead to hyperinsulinism and in rare cases to hyperglycemia. In order to diagnose insulin resistance, regular checking of the blood-sugar level is recommended. Factors that increase the risk of developing diabetes during the treatment with somatropin are: Obesity, familial predisposition, treatment with steroids or existing reduced glucose tolerance. Patients who show 1 of these factors must be kept under close observation during the treatment with Saizen. Saizen should be used with caution in patients with diabetes mellitus or with a family history of this disease. In diabetic patients, it may be necessary to adjust the antidiabetic therapy accordingly.
Dislocation of the Femoral Epiphysis: Patients with endocrine disorders, including growth hormone deficiency or hypothyroidism and in periods of growth, run the risk of increased dislocation of the femoral epiphysis. In children who are being treated with growth hormone, an epiphysiolysis of this type can be caused by the underlying endocrine disease or by the increased rate of growth due to the treatment. Doctors and parents should ensure that any child who develops a limp or complains of pain in the hips or the knees during the treatment with growth hormone is given an appropriate clinical examination.
In children born small for their gestational age, other medical or therapeutic causes that could explain this growth retardation must be excluded before the treatment is started.
In children born small for their gestational age, it is recommended to measure the insulin and glycemic levels in the fasting state before the start of treatment and then once a year. In patients presenting an increased risk of developing diabetes [eg, with a family history of diabetes, obesity, raised body mass index (BMI), severe insulin resistance, acanthosis nigricans] a provoked hyperglycemia test by the oral route must be carried out. In case of clinical diabetes, the growth hormone must not be administered.
In children born small for their gestational age, it is recommended to measure the IGF-1 level before the start of the treatment and then twice a year. If, with repeated measurements, the IGF-1 levels are found to be higher than +2 SDS compared with the standard values for the child's age and pubertal stage, the IGF-1/IGFBP-3 ratio must be taken into account for the adjustment of the dose.
Experience in children born small for their gestational age, with treatment that is started when they are on the point of starting puberty is limited. Consequently, it is not recommended to start the treatment in these patients. Experience in patients with Silver-Russell syndrome is also limited. Part of the increase in height obtained in children of short stature who were born small for their gestational age and who are being treated with somatropin may be lost if the treatment is stopped before they have reached final height.
Patients with Turner's syndrome should be examined by a doctor at regular intervals for possible signs of Scheuermann's disease, especially with the appearance of bone pain.
In the presence of partial or total antepituitary deficiency, substitution therapy with additional hormones (eg, glucocorticoids) may prove to be necessary. In this case, the dosage of this concomitant treatment must be accurately adjusted in order to prevent any growth-inhibiting effects.
Effects on the Ability to Drive or Operate Machinery: Saizen does not interfere with the patient's ability to drive or use machinery.
Use in the elderly: There is only limited experience in patients >60 years. Growth hormone deficiency in adults is a life-long disease and requires appropriate treatment.
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