Demonstrated safety and tolerability profile1

YUVIWEL was generally well tolerated in clinical trials1

Adverse reactions reported in ≥5% of participants treated with YUVIWEL 0.1 mg/kg/week and ≥2% higher than placebo during the placebo-controlled period of Trials 1 and 21

Adverse reaction YUVIWEL, n=68 Placebo, n=42
Vomiting 14 (21%) 6 (14%)
Injection site reaction (ISR)* 13 (19%) 6 (14%)
Pain in extremity 8 (12%) 3 (7%)
Nausea 4 (6%) 0
*ISRs include injection site swelling, injection site erythema, injection site bruising, injection site reaction, injection site pruritus, injection site discoloration, injection site hemorrhage, injection site pain, injection site vesicles, and injection site edema.
Less than one
Children experienced less than 1 ISR per 2 years of exposure to YUVIWEL, on average1,2*

During the double-blind period of Trials 1 and 2, 13 (19%) participants receiving YUVIWEL 0.1 mg/kg/week experienced a total of 25 ISR events (0.4 events/PYE), while 6 (14%) participants receiving placebo experienced a total of 6 events (0.2 events/PYE)

YUVIWEL ISR icon
ALL ISRs were mild and transient
YUVIWEL discontinuations icon
NO discontinuations due to ISRs
Based on PYE in the ApproaCH trial, calculated as exposure-adjusted event rate.2
PYE=person-year exposure.
No serious treatment-related adverse events (TRAEs)2
YUVIWEL (n=57)
0%
Placebo (n=27)
0%
Improvements in both linear growth and height Z-scores were achieved without accelerating bone age1,2
  • No fractures were reported
  • Mean bone age to chronological age ratio remained unchanged from baseline in both groups at Week 52: change of 0 seen with YUVIWEL, -0.013 seen with placebo

Hypertrichosis1

In Trials 1 and 2, hypertrichosis (excessive hair growth) was reported in 3% (n=2) of patients receiving YUVIWEL 0.1 mg/kg/week vs none receiving placebo

  • Cases presented as localized hair growth at injection sites or generalized increased body hair growth affecting limbs, back, or shoulders
  • To reduce the risk of local skin changes, rotate the site of injection with each dose
Only YUVIWEL offers your patients once-weekly dosing1
YUVIWEL dosing icon

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