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AboutEfficacySafetyDosingPortfolioSupportGroAssistEventsMaterialsVideos
Once-weekly GENRYZON has a demonstrated safety profile similar to daily growth hormone (GH) in children with GH deficiency1-3

Based on 5 years of clinical study data.2,4

Incidence of treatment-emergent adverse events (AEs) was comparable to daily GH in a 1-year, phase 3 study3
  • Most AEs were mild to moderate, including injection-site pain1,3
  • Well-tolerated: <1% of patients discontinued therapy due to AEs1,3
COMMON AEs

The most frequently reported all-causality adverse events that occurred in ≥5% of subjects in any treatment group were injection-site pain, nasopharyngitis, headache, pyrexia, cough, injection-site erythema, vomiting, bronchitis, arthralgia, blood creatinine phosphokinase increased, anemia, pharyngitis, hypothyroidism, otitis media, ear pain, oropharyngeal pain, rhinitis, arthropod bite, injection-site pruritus, abdominal pain upper, and tonsillitis.3

The presence of anti-drug antibodies (ADAs) in patients taking GENRYZON did not impact safety or efficacy outcomes1 

Development of ADAs did not appear to affect height velocity or incidence of treatment-emergent adverse events.1,5

Summary of height velocity (cm/year) at month 12 by ADA status5A safety profile demonstrated over 5 years1,2,4
  • Most treatment-emergent AEs were mild or moderate2,4
  • Mean IGF-1 was maintained within normal range during the controlled, open-label extension study2
  • Mean glucose and HbA1C remained within normal range during all time points measured6
Consider GENRYZON for all your appropriate patients age 3 years and older with pediatric GH deficiency1

Learn more about GENRYZON Efficacy and Dosing. 

References:Adapted from GENRYZONTM Local Product Document: LPDGEN092022.Zadik Z, Zelinska N, Iotova V, et al. Results from an open-label extension of the phase 2 dose-finding study of once weekly somatrogon vs daily Genotropin in pediatric patients with growth hormone deficiency (GHD). Poster 6887 presented at: Annual Meeting of the Endocrine Society [virtual]; March 20-23, 2021.
Deal CL. Results of global phase 3 study of once-weekly somatrogon in growth hormone deficient children. Presented at: ENDO Online 2020; June 8-22, 2020.
DATA ON FILE – REFSMT1148, PFIZER LTD: NGENLA® (somatrogon) CP-4-004 Open Label Extension – 5 Year Safety Summary.DATA ON FILE – REFSMT1147, PFIZER LTD: NGENLA® (somatrogon) CP-4-006 Annual Height Velocity by Anti Drug Antibody status.
DATA ON FILE – REFSMT1149, PFIZER LTD: NGENLA® (somatrogon) CP-4-004 Open Label Extension – 5 Year Glucose Metabolism Summary.
Maniatis AK, Carakushansky M, Galcheva S, et al. Perception of treatment burden with once weekly somatrogon vs once daily Genotropin in pediatric patients with growth hormone deficiency: results from a randomized phase 3 study. Poster 6895 presented at: Annual Meeting of the Endocrine Society [virtual]; March 20-23, 2021.

PP-SMT-IND-0027,  05 OCT 2023

 

 EFFICACY

Height outcome comparable to daily GH in children with GH deficiency... with the benefit of fewer injections.1

 View efficacy data DOSING & ADMINISTRATION

Convenient, once-weekly administration.1,7

 See instructions
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