NORDITROPIN NORDIFLEX INJECTION 5 mg/1.5 ml

4.1 Therapeutic indications

Children:

Growth failure due to growth hormone insufficiency, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal children due to chronic renal disease and short children born small for gestational age (SGA).

Growth disturbance (current height standard deviation score (SDS) <‐2.5 and parental adjusted height SDS <‐1) in short children born small for gestational age (SGA), with a birth weight and/or length below ‐2 standard deviation SD, who failed to show catch‐up growth (height velocity standard deviation (HV SDS) <0 during the last year) by 4 years of age or later.

Adults:

Pronounced growth hormone deficiency in known hypothalamic-pituitary disease (one other deficient axis, other than prolactin), demonstrated by one provocative test after institution of adequate replacement therapy for any other deficient axis.

Childhood onset growth hormone insufficiency, reconfirmed by two provocative tests.

In adults, the insulin tolerance test is the provocative test of choice. When the insulin tolerance test is contraindicated, alternative provocative tests must be used. The combined arginine-growth hormone releasing hormone is recommended. An arginine or glucagon test may also be considered; however, these tests have less established diagnostic value than the insulin tolerance test.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour therapy must be completed prior to starting growth hormone (GH) therapy. Treatment should be discontinued if there is evidence of tumour growth.

Somatropin should not be used for longitudinal growth promotion in children with closed epiphyses.

Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure, or similar conditions should not be treated with somatropin (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In children with chronic renal disease, treatment with Norditropin NordiFlex® should be discontinued at renal transplantation.

4.2 Posology and method of administration

Norditropin® should only be prescribed by doctors with special knowledge of the therapeutic indication of use.

Posology

The dosage is individual and must always be adjusted in accordance with the individual’s clinical and biochemical response to therapy.

Patients should be reminded to wash their hands thoroughly with soap and water and/or disinfectant prior to any contact with Norditropin NordiFlex®.

Generally recommended dosages:

Paediatric population:

Growth hormone insufficiency

0.025–0.035 mg/kg/day or 0.7–1.0 mg/m2/day

Turner syndrome

0.045–0.067 mg/kg/day or 1.3–2.0 mg/m2/day

Chronic renal disease

0.050 mg/kg/day or 1.4 mg/m2/day (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Small for Gestational Age

0.033 to 0.067 mg/kg/day or 1.0 to 2.0 mg/m2/day

In all children, clinicians should carefully monitor the growth response, and adjust the hGH dose as necessary. Treatment is usually recommended until final height is reached. Treatment should be discontinued after the first year if height velocity SDS is below +1. Treatment should be discontinued when final height is reached (defined as height velocity <2 cm/year), and if confirmation is required if bone age is >14 years (girls) or >16 years (boys), corresponding to closure of the epiphyseal growth plates.

Adult population:

Replacement therapy in adults

It is recommended to start treatment with a low dose 0.1–0.3 mg/day. It is recommended to increase the dosage gradually at monthly intervals based on the clinical response and the patient’s experience of adverse events. Serum IGF-1 can be used as guidance for the dose titration. Women may require higher doses than men, with men showing an increasing IGF-1 sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are undertreated while men are overtreated.

Dose requirements decline with age. Maintenance dosages vary considerably from person to person, but seldom exceed 1.0 mg/day.

Method of administration

Generally, daily subcutaneous administration in the evening is recommended. The injection site should be varied to prevent lipoatrophy.