NGENLA® Adverse Reactions

(somatrogon-ghla)

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]
Severe hypersensitivity [see Warnings and Precautions (5.2)]
Increased risk of neoplasm [see Warnings and Precautions (5.3)]
Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]
Intracranial hypertension [see Warnings and Precautions (5.5)]
Fluid retention [see Warnings and Precautions (5.6)]
Hypoadrenalism [see Warnings and Precautions (5.7)]
Hypothyroidism [see Warnings and Precautions (5.8)]
Slipped capital femoral epiphysis [see Warnings and Precautions (5.9)]
Progression of preexisting scoliosis [see Warnings and Precautions (5.10)]
Pancreatitis [see Warnings and Precautions (5.11)]
Lipoatrophy [see Warnings and Precautions (5.12)]
Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.13)]

6.1 Clinical Trials Experience

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.

Table 1  Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)
Adverse reactions that are medically related were grouped to a single preferred term.
*
Injection site reactions included: injection site pain (39% somatrogon-ghla vs 25% daily somatropin), injection site swelling/induration/hypertrophy/inflammation (10% somatrogon-ghla vs 1% daily somatropin), injection site erythema (8% somatrogon-ghla vs none daily somatropin), injection site pruritus (5% somatrogon-ghla vs none daily somatropin), injection site hemorrhage (5% somatrogon-ghla vs none daily somatropin).
Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis.

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%).

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Adverse Reactions

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)]
Severe hypersensitivity [see Warnings and Precautions (5.2)]
Increased risk of neoplasm [see Warnings and Precautions (5.3)]
Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)]
Intracranial hypertension [see Warnings and Precautions (5.5)]
Fluid retention [see Warnings and Precautions (5.6)]
Hypoadrenalism [see Warnings and Precautions (5.7)]
Hypothyroidism [see Warnings and Precautions (5.8)]
Slipped capital femoral epiphysis [see Warnings and Precautions (5.9)]
Progression of preexisting scoliosis [see Warnings and Precautions (5.10)]
Pancreatitis [see Warnings and Precautions (5.11)]
Lipoatrophy [see Warnings and Precautions (5.12)]
Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.13)]

6.1 Clinical Trials Experience

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.

Table 1  Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)
Adverse reactions that are medically related were grouped to a single preferred term.
*
Injection site reactions included: injection site pain (39% somatrogon-ghla vs 25% daily somatropin), injection site swelling/induration/hypertrophy/inflammation (10% somatrogon-ghla vs 1% daily somatropin), injection site erythema (8% somatrogon-ghla vs none daily somatropin), injection site pruritus (5% somatrogon-ghla vs none daily somatropin), injection site hemorrhage (5% somatrogon-ghla vs none daily somatropin).
Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis.

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%).

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