Norditropin Nordiflex

Norditropin Nordiflex

somatropin

Manufacturer:

Novo Nordisk

Marketer:

Ferron
Concise Prescribing Info
Contents
Human somatropin (Recombinant DNA origin)
Indications/Uses
Adult & childhood onset growth hormone deficiency (GHD). In childn, growth failure due to GHD, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal childn due to chronic renal disease & short childn born small for gestational age (SGA), who failed to show catch-up growth by 4 yr.
Dosage/Direction for Use
SC Individualized dosage. Adult Adult onset GHD Recommended starting dose: 0.1-0.3 mg daily & to increase the dosage gradually at mthly intervals in order to meet the need of the individual patient. Childhood onset GHD Recommended dose to restart: 0.2-0.5 mg daily w/ subsequent dose adjustment on the basis of IGF-1 conc determination. Childn Growth hormone deficiency 0.025-0.035 mg/kg daily or 0.7-1 mg/m2 daily. Turner syndrome 0.045-0.067 mg/kg daily or 1.3-2 mg/m2 daily. Childn w/ chronic renal disease 0.05 mg/kg daily or 1.4 mg/m2 daily. Childn born small for gestational age (SGA) 0.033-0.067 mg/kg daily or 1-2 mg/m2 daily.
Contraindications
Hypersensitivity. Evidence of tumour activity or growth. Longitudinal growth promotion in childn w/ closed epiphyses. Acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. For childn w/ chronic renal disease, treatment w/ Norditropin NordiFlex should be discontinued at renal transplantation. Pregnancy & lactation.
Special Precautions
Childn should be regularly assessed by a specialist in child growth. Patients w/ >10 yr of treatment in adult growth hormone deficiency. Monitor growth of hands & feet in Turner syndrome patients. Perform careful otological evaluation in girls w/ Turner syndrome. Monitor renal function during treatment especially in patients w/ chronic renal disease. Previous malignant disease, leukemia, benign intracranial HTN, scoliosis, patients w/ endocrine disorders & short stature. Perform thyroid function tests regularly. Monitor glucose levels periodically. Patients w/ pre-existing type 1 or type 2 DM or impaired glucose tolerance. Measure IGF-1 level before start of treatment & regularly thereafter. There have been reports of fatalities after initiating therapy w/ growth hormone in paed patients w/ Prader-Willi syndrome, for which Norditropin is not approved. Fatalities were reported in patients who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified resp infection. Rule out other medical reasons or treatments in short childn born SGA prior to treatment. Not recommended near onset of puberty. Previously undiagnosed central (secondary) hypoadrenalism may be unmasked & glucocorticoid replacement may be required. Evaluate patients who develop a limp or complains of hip or knee pain. Replacement in adult GHD patients should preferably be monitored by an endocrinologist w/ special experience in pituitary disease. Patients >60 yr.
Adverse Reactions
Peripheral oedema. Headache, paraesthesia; arthralgia, joint stiffness, myalgia.
Drug Interactions
Concomitant treatment w/ glucocorticoids inhibits the growth promoting effect of somatropin. Somatropin may increase the clearance of compd metabolised by cytochrome P4503A4 (eg, sex steroids, corticosteroids, anticonvulsants & cyclosporine). The effect of somatropin can be influenced by additional therapy w/ other hormones eg, gonadotropin, anabolic steroids, oestrogen & thyroid hormone. Insulin dose adjustment may be needed after initiation of somatropin treatment.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.
Presentation/Packing
Form
Norditropin Nordiflex soln for inj 5 mg/1.5 mL
Packing/Price
1's (Rp2,500,000/boks)
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