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%).
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_body_html_patient}}
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Pfizer Safety
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
Pfizer Safety Reporting Site*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.
FDA Medwatch
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 call (800) 822-7967.