Established Safety Profile

The safety profile of SKYTROFA® has been established in pediatric patients aged 1 year and older who weigh at least 11.5 kg1

Boy playing with drum kit.
  • No patients experienced serious AEs or discontinuations related to SKYTROFA2
  • Low immunogenicity, with no neutralizing antibodies detected1,2
    • Only 6.3% (19 of 304) of patients showed detectable binding antibodies at any time1

AEs reported in ≥ 5% of SKYTROFA-treated pediatric patients and more frequently than in daily somatropin-treated pediatric patients (52 weeks of treatment)1

AEs SKYTROFA
(n = 105)
Daily Somatropin
(n = 56)
n (%) n (%)
Viral infection 16 (15%) 6 (11%)
Pyrexia 16 (15%) 5 (9%)
Cough 11 (11%) 4 (7%)
Nausea and vomiting 11 (11%) 4 (7%)
Hemorrhage* 7 (7%) 1 (2%)
Diarrhea 6 (6%) 3 (5%)
Abdominal pain 6 (6%) 2 (4%)
Athralgia and arthritis 6 (6%) 1 (2%)
* The etiology of hemorrhage in the SKYTROFA treatment group included epistaxis (n = 3), contusion (n = 2), petechiae (n = 1), and eye hemorrhage (n = 1).1
The etiology of arthralgia and arthritis in the SKYTROFA treatment group included arthralgia (n = 5) and reactive arthritis (n = 1).1