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Patients switching from daily somatropin:

Stop the final dose of daily somatropin one day before starting Sogroya®. Allow at least 8 hours between the final dose of somatropin and the first dose of Sogroya®.1

 

Patients switching from weekly GH therapy:

Patient switching from a weekly GH therapy are recommended to continue same weekly dosing schedule with Sogroya®.1

If within 3 days of missed dose:

Dose should be taken as soon as possible, and then resume the usual dosing schedule.1

 

If more than 3 days after missed dose:

Dose should be skipped, and the next dose should be taken on the regularly scheduled day.1

Sogroya® can be taken up to 2 days before or 3 days after the patients scheduled weekly dosing day. Resume the next dose on the regularly scheduled dosing day.1

Sogroya® should be taken on the same day each week, and the day can be chosen by the patient. Weekly dosing day can be changed, as long as the time between 2 doses is at least 4 days (96 hours).1

The Sogroya® dose may be individualised and adjusted based on growth velocity, adverse reactions, body weight and serum insulin-like growth factor I (IGF-I) concentrations.
Average IGF-I standard deviation score (SDS) levels (drawn 4 days after dosing) can guide dose titration. Dose adjustments should be targeted to achieve average IGF-I SDS levels in the normal range, i.e. between -2 and +2 (preferably close to 0 SDS).
If the IGF-I (SDS) is > 2, it should be reassessed after the subsequent Sogroya® administration. If the value remains > 2, reducing the dose by 0.04 mg/kg/week is recommended. More than one dose reduction may be required in some patients.

In patients who have had the dose reduced but are not growing well, the dose may be gradually increased as tolerated up to a maximum dose of 0.16 mg/kg/week. Dose increments should not exceed 0.02 mg/kg per week.

1.

Sogroya® Summary of Product Characteristics. 2022:1-92.

2.

Norditropin® FlexPro® Summary of Product Characteristics. 2021:1-65.

3.

Miller BS JC Rasmussen MH, et al. Weekly Somapacitan is Effective and Well Tolerated In children With GH Deficiency: The Randomised Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 022:00(0):1-11.

4.

Rohrer. T.R., Horikawa, R., & Kappelgaard, A. M. (2017). Growth hormone delivery devices: current features and potential for enhanced treatment adherence. Expert Opin Drug Deliv. 2017;14(11): 1253-1264.

5.

Laursen T et al 2006 Pain Perception after Subcutaneous Injections of Media Containing Different Buffers. Basic Clin Pharmacal Toxicol. 2006;98:218-221.

6.

Kappelgaard A-M, Mikkelsen S, Bagger C, Fuchs GS. Children and adolecent acceptability of a new device system to administer human growth hormone - a pilot study. J Pediatr Endocr Met. 2012;25(3-4):285-294