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GENOTROPIN (somatropin [rDNA origin] for injection) Dosage And Administration

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Dosage And Administration

Therapy with GENOTROPIN (somatropin for injection) 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), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.

The GENOTROPIN dosage and administration schedule should be individualized based on the growth response of each patient.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).

Treatment with GENOTROPIN for short stature should be discontinued when the epiphyses are fused.

Recommended Dose and Dosage Adjustment

The recommended dosage of GENOTROPIN is:

 

1GENOTROPIN dosage must be adjusted for the individual patient.

 

2Final dose should be individually increased as required with respect to age and gender to a maximum daily maintenance dose of 1.33 mg. Women may require higher doses than men. This means that there is a risk that women, especially those on oral estrogen replacement may be under-treated. As normal physiological growth hormone production decreases with age, dose requirements may be reduced.

 

3 Treatment should stop when near adult height is achieved (height velocity <2cm/yr and/or bone age >16 yr in boys and >14 yr in girls) or when height is in the normal adult range (above -2 SDS).

 

4GENOTROPIN may be administered in the thigh, buttocks or abdomen; the site of SC injections should be rotated daily to help prevent lipoatrophy.

Indication

Recommended Dose (mg/kg body weight)

Route4

Comments

Pediatric Growth Hormone Deficiency1

 

0.16 - 0.24 mg/kg body weight/week

SC

Divided into 6-7 doses

Diagnosis of GHD should be confirmed before GENOTROPIN is administered.

Adults Growth Hormone Deficiency

0.15 - 0.3 mg/day2

SC

Divided into 6-7 doses

Turner Syndrome1

 

0.33 mg/kg body weight per week

SC

Divided into 6-7 doses

Idiopathic Short Stature1

 

UP TO 0.47 mg/kg body weight per week3

SC

Divided into 6-7 doses

Small for Gestational Age1

UP TO 0.48 mg/kg body weight per week

SC

Divided into 6-7 doses

Adults Growth Hormone Deficiency
Clinical response, side effects and determination of IGF-1 in serum may be used as guidance for dose titration. The level of IGF-1 should not exceed the upper limit of normal IGF-1 levels matched to age and sex. 

It is recommended that IGF-I concentrations be monitored regularly and GH dose be reduced in children with a plasma IGF-1 above + 2SD.

Small for Gestational Age
Recent literature has recommended initial treatment with larger doses of somatropin (e.g., 0.48 mg/kg/week), especially in very short children (i.e., height SDS <–3), and/or older/ pubertal children, and that a reduction in dosage (e.g., gradually towards 0.24 mg/kg/week) should be considered if substantial catch-up growth is observed during the first few years of therapy. On the other hand, in younger SGA children (e.g., approximately <4 years) with less severe short stature (i.e., baseline height SDS values between -2 and -3), consideration should be given to initiating treatment at a lower dose (e.g., 0.24 mg/kg/week), and titrating the dose as needed over time. In all children, clinicians should carefully monitor the growth response, and adjust the somatropin dose as necessary.

Dosing should continue until final height is reached (see DETAILED PHARMACOLOGY, Human Pharmacology, Pharmacodynamics). Treatment should be discontinued after the first year of treatment if the height velocity SDS is below + 1. Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys) corresponding to closure of the epiphyseal growth plates.

In short children born SGA, it is recommended that IGF I concentration be measured before initiation of treatment and monitored every 6 months thereafter.  If on repeated measurements IGF-I concentrations 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. 

Administration

See CONSUMER INFORMATION for detailed information.

All parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.  If the solution is cloudy, the contents MUST NOT be injected.

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