Norditropin NordiFlex

Norditropin NordiFlex

somatropin

Manufacturer:

Novo Nordisk

Distributor:

DKSH
Concise Prescribing Info
Contents
Somatropin
Indications/Uses
Adult: Adult & childhood onset growth hormone deficiency (GHD). 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 & growth disturbance in 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 Replacement therapy: Adult onset GHD Initially 0.1-0.3 mg daily, to be increased gradually at mthly intervals. Max maintenance dose: 1 mg daily. Childhood onset GHD Restart w/ 0.2-0.5 mg daily w/ subsequent dose adjustment on the basis of insulin-like growth factor (IGF-I) conc determination. Childn GHD 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. Chronic renal disease 0.05 mg/kg daily or 1.4 mg/m2 daily. Born SGA 0.035 mg/kg daily or 1 mg/m2 daily.
Contraindications
Hypersensitivity. Not to be used when there is evidence of tumour activity; for longitudinal growth promotion in childn w/ closed epiphyses. Patients w/ acute critical illness suffering complications following open heart & abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. Discontinue at renal transplantation for childn w/ chronic renal disease.
Special Precautions
Discontinue if benign intracranial HTN is diagnosed. Not to be administered if overt diabetes occurs. Not recommended in SGA patients near onset of puberty. Neoplasms; leukemia; Ab development; acute adrenal insufficiency. Patients w/ >5 yr treatment in adult GHD. Rule out other medical reasons or treatments that could explain growth disturbance in short childn born SGA prior to treatment. Monitor growth of hands & feet in Turner syndrome patients. Perform otological evaluation annually in girls w/ Turner syndrome. Monitor renal function, signs of scoliosis, thyroid function & for evidence of glucose intolerance. Measure fasting insulin & blood glucose prior to treatment & annually thereafter, & IGF-I level prior to treatment & twice yrly thereafter in Turner syndrome & SGA childn. Perform oral glucose tolerance testing in patients w/ increased risk of DM. Dose adjustment may be needed in concomitant use w/ oral oestrogen therapy. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn w/ Prader-Willi & Silver-Russell syndrome. Elderly w/ adult GHD >60 yr.
Adverse Reactions
Adult: Peripheral oedema. Headache, paraesthesia; arthralgia, joint stiffness, myalgia.
Drug Interactions
Inhibition of growth-promoting effect w/ glucocorticoid. May increase clearance of compd metabolised by cytochrome P450 3A4 (eg, sex steroids, corticosteroids, anticonvulsants & cyclosporine). Influenced effect on final height by additional therapy w/ other hormones eg, gonadotropin, anabolic steroids, oestrogen & thyroid hormone. Insulin dose adjustment may be needed after initiating 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
10 × 1's;1's;5 × 1's
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