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▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.

Once-weekly NGENLA 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

There were no clinical or safety effects observed with the formation of anti-drug antibodies (ADAs) in patients taking NGENLA1 

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 status3,5

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

A safety profile demonstrated over 5 years1,2,4,6
  •  
  • Most treatment-emergent AEs were mild or moderate and not related to study treatment2,4
  • 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 NGENLA for all your appropriate patients age 3 years and older with pediatric GH deficiency1

Ngenla▼ Prescribing Information

References:NGENLA® Summary of Product CharacteristicsZadik Z, Zelinska N, Iotova V et al. An open-label extension of a phase 2 dose-finding study of once-weekly somatrogon vs. once-daily Genotropin in children with short stature due to growth hormone deficiency: results following 5 years of treatment. J Pediatr Endocrinol Metab 2023; aopDeal et al (2022). Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency:A Phase 3 Study. JCEM 2022, 107, e2717–e2728DATA ON FILE – REFSMT1148, PFIZER LTD: NGENLA® (somatrogon) CP-4-004 Open Label Extension – 5 Year Safety Summary.Deal et al (2022). Efficacy and Safety of Once Weekly Somatrogon in Pediatric Subjects with Growth Hormone Deficiency: Lack of Impact of Anti-Drug Antibodies. Presented at ESPE 2022: Sept 15th-17th 2022DATA ON FILE – REFSMT1149, PFIZER LTD: NGENLA® (somatrogon) CP-4-004 Open Label Extension – 5 Year Glucose Metabolism Summary.
EFFICACY

Access data on the efficacy of NGENLA.
 

 View efficacy data DOSING & ADMINISTRATION

Click here for more information on NGENLA once weekly dosing and administration.

 See instructions PATIENT SUPPORT

Support for your patients throughout their treatment journey.​​​​​​​

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Legal Category: S1A
Further information is available upon request

PP-NGE-IRL-0017 Date of Preparation Dec 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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