Somatrogon-Ghla (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- NGENLA
Indications and Usage
NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone.
Contraindications
•Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1)]. •Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA [see Warnings and Precautions (5.2)]. •Closed epiphyses. •Active malignancy due to the risk of malignancy progression [see Warnings and Precautions (5.3)]. •Active proliferative or severe non-proliferative diabetic retinopathy [see Warnings and Precautions (5.4)]. •Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.13)].
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)]
Drug Interactions
Table 2 includes a list of drugs with clinically significant drug interactions when administered concomitantly with NGENLA and instructions for preventing or managing them. Table 2 Clinically Significant Drug Interactions with NGENLA Replacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. Growth hormone inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NGENLA may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. Intervention: Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of NGENLA [see Warnings and Precautions (5.7) ]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. Supraphysiologic Glucocorticoid Treatment Clinical Impact: Supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of NGENLA in pediatric patients. Intervention: Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth. Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes. Intervention: Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes. Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to NGENLA. Intervention: Patients
Mechanism of Action
Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1). GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in pediatric patients with GHD.
Overdosage
Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism consistent with the effects of excess growth hormone.