Features of SKYTROFA
Established safety profile
- In a clinical study, some children taking once-weekly SKYTROFA had mild injection-site reactions
- Side effects occurring more frequently than with daily somatropin included viral infection, fever, cough, nausea and vomiting, bleeding, diarrhea, stomach area pain, and joint pain and arthritis
* Store SKYTROFA in the original package to protect from light. Do not freeze. SKYTROFA can be stored at room temperature (not to exceed 86°F [30°C]) for up to 6 months. Alternatively, SKYTROFA can be stored under refrigeration at 36°F to 46°F (2°C to 8°C) until the expiration date. If refrigerated, keep at room temperature for 15 minutes before use. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was ﬁrst removed from refrigeration (whichever is earlier).
† In a clinical trial that compared once-weekly SKYTROFA with a daily somatropin in 161 children with pediatric GHD who previously had not been on treatment. The primary endpoint from the clinical trial was annualized height velocity (AHV) at 52 weeks. AHV at 52 weeks was 11.2 cm/year for SKYTROFA versus 10.3 cm/year for a daily somatropin.
‡ SKYTROFA was studied in a 26-week clinical trial investigating the safety, tolerability, and efficacy of SKYTROFA administered once weekly in children with pediatric GHD. The trial included 3 children who previously had not been on treatment and 143 children previously treated with daily growth hormone therapies for ≤ 130 weeks. Safety and tolerability were the primary endpoints.
SKYTROFA dosing considerations
The recommended dose of SKYTROFA for treatment-naïve patients and patients switching from daily somatropin therapy is 0.24 mg/kg body weight, given once weekly.
- Your healthcare provider will individualize and adjust the dosage of SKYTROFA based on response
- When changing from daily somatropin therapy to once-weekly SKYTROFA, you should wait at least 8 hours between the final dose of daily somatropin and the first dose of once-weekly SKYTROFA