SOGROYA (Page 3 of 8)

5.9 Slipped Capital Femoral Epiphysis in Pediatric Patients

Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain.

5.10 Progression of Preexisting Scoliosis in Pediatric Patients

Somatropin increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression.

5.11 Pancreatitis

Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain.

5.12 Lipohypertrophy/Lipoatrophy

When SOGROYA is administered subcutaneously at the same site over a long period of time, tissue lipohypertrophy or lipoatrophy may result. Rotate injection sites when administering SOGROYA to reduce this risk [see Dosage and Administration (2.1)].

5.13 Sudden Death in Pediatric Patients with Prader-Willi Syndrome

There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. SOGROYA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

5.14 Laboratory Tests

Serum levels of inorganic phosphorus and alkaline phosphatase may increase after SOGROYA therapy. Serum levels of parathyroid hormone may increase with somatropin treatment.

6 ADVERSE REACTIONS

The following clinically significant adverse drug 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 neoplasms [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 in pediatric patients [see Warnings and Precautions (5.9)]
Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.10)]
Pancreatitis [see Warnings and Precautions (5.11)]
Lipohypertrophy/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.

Pediatric Patients with GHD

SOGROYA was studied in a 52-week randomized, open-label, active-controlled, parallel-group clinical study in 200 treatment naïve, prepubertal pediatric patients with growth hormone deficiency [see Clinical Studies (14.1)]. Table 2 shows common adverse reactions that occurred in 5% of patients treated with either SOGROYA or somatropin in this trial.

Table 2. Adverse Reactions occurring ≥5% in SOGROYA or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)

Somatropin

(N=68)

SOGROYA

(N=132)

Adverse Reactions

%

%

Nasopharyngitis a

16.2

16.7

Headache

8.8

12.1

Pyrexiab

11.8

9.1

Pain in extremityc

2.9

9.8

Injection site reactiond

5.9

6.1

Diarrheae

5.9

4.5

Nausea/vomitingf

5.9

4.5

Bronchitis

7.4

3

a Nasopharyngitis in the SOGROYA treatment group included nasopharyngitis (11.4%), rhinitis (3.8%), pharyngitis streptococcal (0.8%), acute sinusitis (0.8%), nasal congestion (0.8%), pharyngitis (0.8%), and sinusitis (0.8%).
b Pyrexia in the SOGROYA treatment group included pyrexia (8.3%) and hyperthermia (0.8%).
c Pain in extremity in the SOGROYA treatment group included pain in extremity (9.1%) and growing pains (0.8%).
d Injection site reaction in the SOGROYA treatment group included injection site bruising (1.5%), injection site pain (1.5%), injection site hematoma (1.5%), injection site reaction (0.8%), and injection site swelling (0.8%)
e Diarrhea in the SOGROYA treatment group included diarrhea (2.3%), gastroenteritis viral (1.5%), and gastrointestinal viral infection (0.8%)
f Nausea/vomiting in the SOGROYA treatment group included vomiting (4.5%) and nausea (1.5%)

Adult Patients with GHD

SOGROYA was studied in adult patients with GHD in a 35-week, placebo-controlled, double-blind trial with an active-control arm [see Clinical Studies (14.2)]. Adverse reactions occurring >2% with SOGROYA are presented in Table 3.

Table 3. Adverse Reactions occurring >2% in Adults with GHD Treated with SOGROYA and More Frequently# than in Placebo-Treated Patients for 34 Weeks

Placebo

(N=61)

SOGROYA

(N=120)

Adverse Reactions

%

%

Back pain

3.3

10

Arthralgia

1.6

6.7

Dyspepsia

3.3

5

Sleep disorder

1.6

4.2

Dizziness

1.6

4.2

Tonsillitis

1.6

3.3

Peripheral edema

1.6

3.3

Vomiting

1.6

3.3

Adrenal insufficiency

1.6

3.3

Hypertension

1.6

3.3

Blood creatine phosphokinase increase

0

3.3

Weight increased

0

3.3

Anemia

0

2.5

# Included adverse reactions reported with at least 1% greater incidence in SOGROYA group compared to the placebo group

More SOGROYA treated patients shifted from normal baseline levels to elevated phosphate and creatine phosphokinase levels at the end of the trial compared to the placebo group (17.5% vs 4.9% and 9.2% vs. 6.6%, respectively); these laboratory changes occurred intermittently, and were non-progressive.

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