Eutropin S Pen Injection Special Precautions

Eutropin S Pen Inj. should be carefully administered in following cases.
Because transient undesirable side effect may be induced by Eutropin S Pen Inj., patients with heart and kidney disease should be carefully monitored.
Patients with familial history of diabetes mellitus.
Treatment of GHD with Eutropin S Pen Inj. should be initiated by a paediatrician who specializes in treating disorders of the endocrine system.
Small for Gestational Age: 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.
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.
Neoplasms: Patients with signs of developing malignancies and patients with growth hormone deficiency secondary to an intracranial lesion should be regularly examined for progression or recurrence of the underlying disease prior to the therapy and Eutropin S Pen Inj. should be carefully administered in this case. In pediatric patients, clinical literature has demonstrated no relationship between somatropin therapy and central nervous system (CNS) tumour recurrence or new intracranial tumors. However, in childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. If the lesion is on the skin, it should be carefully monitored for increased growth, or potential malignant changes.
Impaired Glucose Tolerance and Diabetes Mellitus: Because of the diabetogenic action of growth hormone, hyperglycemia and ketosis may occur and a state of insulin resistance may be induced, patients should be closed monitored for evidence of glucose intolerance. New-onset Type 2 diabetes mellitus has been occasionally reported. In most of these cases, there were risk factors such as obesity, family history of diabetes mellitus, steroid treatment, or previously impaired glucose tolerance. In patients with previously diagnosed diabetes, the dosage of antidiabetic agents in somatropin therapy may need to be adjusted. Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus.
Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs (i.e., insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients.
Insulin resistance induced by somatropin may lead to increased blood sugar and urine glucose, and it is advisable that urine glucose test is conducted periodically.
Intracranial Hypertension: Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea and/or vomiting has been reported in a small number of patients treated with somatropin products. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude pre-existing papilledema, and periodically during the course of somatropin therapy. If papilledema is observed by funduscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with somatropin can be restarted at a lower dose after IH associated signs and symptoms have resolved. Patients with Turner syndrome may be at increased risk for the development of IH.
Fluid Retention: Eutropin S Pen Inj. may induce overfiltration with increasing renal plasma flow and glomerular filtration rate, patients should be carefully monitored in long-term.
Hypoglycemia: Hypoglycemia may occur in the rare case of intermittent administration and the switch to daily administration is recommended.
Thyroid Function: Growth hormone increases the extrathyroidal conversion of T4 to T3 which may result in a reduction in serum T4 and an increase in serum T3 concentrations. Whereas the peripheral thyroid hormone levels have remained within the reference ranges in the majority of healthy subjects, hypothyroidism theoretically may develop in subjects with subclinical hypothyroidism. 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.
Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children. Patients with hypothyroidism should be examined periodically and treated with thyroid hormone, if necessary.
Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.
Patients with hypothyroidism (lacking in multiple pituitary hormones) should be closely monitored for hormone replacement therapy during treatment with somatropin.
Slipped Capital Femoral Epiphyses in Pediatric Patients: Slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders (including GHD and Turner syndrome) or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
Progression of Preexisting Scoliosis in Pediatric Patients: Progression of scoliosis can occur in patients who experience rapid growth. Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.
Otitis Media and Cardiovascular Disorders in Turner Syndrome: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.
Lipoatrophy: When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site.
Allergic Reactions: As with other proteins, local or systemic allergic reactions may occur, and patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs.
Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH) and IGF-I may increase during somatropin therapy.
Anti-hGH Antibodies: Because antibody to human growth hormone may be formed, antibodies to growth hormone should be determined periodically.
In successive treatment of Eutropin S Pen Inj., antibody to human growth hormone may be formed and the effect of growth hormone may also be decreased, so Eutropin S Pen Inj. should be discontinued in those cases and appropriate medical therapy should be instituted.
Others: Therapy with somatropin should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD).
If growth hormone therapy is used in patients with panhypopituitarism, standard hormone replacement therapy should be carefully monitored.
Effects on Ability to Drive and Use Machines: It is not known whether somatropin affects the ability to drive and use machines.