Somatrogon-ghla
Generic Name: somatrogon-ghla
Brand Names:
Ngenla
11 DESCRIPTION Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa.
Overview
11 DESCRIPTION Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa.
Uses
1 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. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION • NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency ( 2.1 ). • Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site ( 2.1 ). • The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly ( 2.3 ). • Individualize dosage for each patient based on the growth response ( 2.3 ). • Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection ( 2.3 ).
Side Effects
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 Precauti...
Interactions
7 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.
Warnings
5 WARNINGS AND PRECAUTIONS • Severe Hypersensitivity : Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.2 ). • Increased Risk of Neoplasms : Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ). • Glucose Intolerance and Diabetes Mellitus : NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development ( 5.4 ). 4 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on NGENLA use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon-ghla subcutaneously during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure (see Data ) . The background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S.
Storage
Storage and Handling Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight.
Frequently Asked Questions
What is Somatrogon-ghla used for?▼
1 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. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).
What are the side effects of 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 Precauti...
Can I take Somatrogon-ghla during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on NGENLA use in pregnant women to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In reproduction studies with pregnant rats, there was no evidence of embryo-fetal toxicity following administration of somatrogon-ghla subcutaneously during organogenesis at doses up to 45 times the maximum recommended human dose based on exposure (see Data ) . The background risk of major birth defects and miscarriage in the indicated population is unknown. In the U.S.
What are the important warnings for Somatrogon-ghla?▼
5 WARNINGS AND PRECAUTIONS • Severe Hypersensitivity : Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.2 ). • Increased Risk of Neoplasms : Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ). • Glucose Intolerance and Diabetes Mellitus : NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development ( 5.4 ). 4 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.