(somatrogon-ghla)
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Safety data are derived from a safety and efficacy study in pediatric patients with GHD [see Clinical Studies (14.1)]. The data from the 12-month main study period reflect exposure of 109 patients to NGENLA administered once weekly (0.66 mg/kg/wk) and 115 patients to somatropin administered once daily (0.034 mg/kg/day).
The mean age across the treatment groups, was 7.7 years (min 3.01, max 11.96); 40.2% of patients were >3 years to ≤7 years, 59.8% were >7 years, 71.9% of patients were male, and 28.1% were female. In this study, 74.6% of patients were White, 20.1% were Asian, 0.9% were Black or African American, 0.5% were American Indian or Alaska Native, 0.5% were Native Hawaiian or Other Pacific Islander, and for 3.6% race information was missing; 10.7% of patients identified as Hispanic or Latino. Baseline disease characteristics were balanced across treatment groups.
Table 1 shows the adverse reactions that occurred in ≥5% of patients treated with NGENLA or daily somatropin during the 12-month main study period. Reporting of injection site reactions was solicited through the use of a patient diary after each weekly injection for patients administered NGENLA and once weekly for patients administered daily injections of somatropin.
| Adverse reactions that are medically related were grouped to a single preferred term. | ||
| ||
Adverse Drug Reactions | Daily Somatropin (N=115) n (%) | NGENLA (N=109) n (%) |
Injection site reactions* | 29 (25.2) | 46 (42.2) |
Nasopharyngitis† | 33 (28.7) | 36 (33) |
Headache | 25 (21.7) | 18 (16.5) |
Pyrexia | 17 (14.8) | 18 (16.5) |
Anemia | 10 (8.7) | 10 (9.2) |
Cough | 9 (7.8) | 9 (8.3) |
Vomiting | 9 (7.8) | 8 (7.3) |
Hypothyroidism | 3 (2.6) | 7 (6.4) |
Abdominal pain | 8 (7.0) | 7 (6.4) |
Rash | 7 (6.1) | 6 (5.5) |
Oropharyngeal pain | 4 (3.5) | 6 (5.5) |
Arthralgia | 8 (7.0) | 5 (4.6) |
Otitis media | 10 (8.7) | 5 (4.6) |
Tonsillitis | 6 (5.2) | 5 (4.6) |
Bronchitis | 9 (7.8) | 3 (2.8) |
Laboratory Tests
More NGENLA-treated patients shifted from normal eosinophil levels at baseline to elevated eosinophil levels at the end of the 12-month study compared to the daily somatropin group (29% vs 12%).
{{section_name_patient}}
{{section_body_html_patient}}
Additional Resources
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.
Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.
Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for a Pfizer medicine or a vaccine.
The submission will be reviewed during our standard business hours.
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.