Version May 2024
Growth hormone deficiency (GHD):
Children 3 to 11 years: SUBQ: 0.66 mg/kg/dose once weekly; individualize dose based on growth velocity, body weight, and insulin-like growth factor-1 (IGF-1); treat with the lowest effective dose (Ref). Discontinue treatment if there is evidence of epiphysial growth plate closure.
Converting from daily growth hormone products: Begin therapy 1 day after last daily injection of other product.
Dosage adjustment for IGF-1: If IGF-1 is >2 standard deviation scores higher than mean reference value for age and sex, decrease dose by 15%. More than one dose reduction may be necessary.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for children.
>10%:
Hematologic & oncologic: Eosinophilia (29%)
Immunologic: Antibody development (77%; neutralizing: 4%)
Local: Injection-site reaction (42%; including bleeding at injection site [5%], erythema at injection site [8%], hypertrophy at injection site [≤10%], induration at injection site [≤10%], inflammation at injection site [≤10%], injection-site pruritus [5%], pain at injection site [39%], swelling at injection site [≤10%])
Nervous system: Headache (17%)
Respiratory: Nasopharyngitis (33%)
Miscellaneous: Fever (17%)
1% to 10%:
Dermatologic: Skin rash (6%)
Endocrine & metabolic: Hypothyroidism (6%)
Gastrointestinal: Abdominal pain (6%), vomiting (7%)
Hematologic & oncologic: Anemia (9%)
Neuromuscular & skeletal: Arthralgia (5%)
Respiratory: Bronchitis (3%), cough (8%), oropharyngeal pain (6%)
Hypersensitivity to somatrogon or any component of the formulation; acute critical illness after open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure; closed epiphyses; active malignancy; diabetic retinopathy (active proliferative or severe nonproliferative); patients with Prader-Willi syndrome who have severe obesity, severe respiratory impairment, history of upper airway obstruction, or history of sleep apnea.
Canadian labeling: Additional contraindications (not in US labeling): Active tumors.
Concerns related to adverse effects:
• Fluid retention: Fluid retention may occur; manifestations of fluid retention (eg, edema, nerve compression including carpal tunnel syndrome/paresthesia) are generally transient and dose dependent.
• Glucose intolerance: Growth hormone may decrease insulin sensitivity especially at higher doses. New onset type 2 diabetes mellitus has been reported. Adjustment of antidiabetic medications may be necessary.
• Hypersensitivity: Serious systemic hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported with growth hormone; institute immediate medical attention if hypersensitivity occurs.
• Intracranial hypertension: Intracranial hypertension with headache, nausea, papilledema, visual changes, and/or vomiting has been reported in patients receiving growth hormone treatment; symptoms usually occur within the first 8 weeks of therapy and signs and symptoms of intracranial hypertension may rapidly resolve after discontinuation or reduction of dose.
• Lipoatrophy: Lipoatrophy has been reported at injection sites when used at the same site for a prolonged period. Ensure proper injection technique and rotate injection sites.
• Neoplasm: Increased risk of malignancy progression in patients with active malignancy; any preexisting malignancy should be inactive and treatment complete prior to initiating therapy. An increased risk of second neoplasm has been reported in childhood cancer survivors treated with somatropin; the most common second neoplasms were meningiomas in patients treated with radiation to the head for their first neoplasm. Patients with short stature (genetic cause) have increased baseline risk of developing malignancies; consider risk/benefits prior to initiation of therapy and monitor these patients carefully.
• Pancreatitis: Pancreatitis has been reported in patients receiving growth hormone.
• Slipped capital femoral epiphyses: Patients with endocrine disorders (including growth hormone deficiency and Turner syndrome) or patients undergoing rapid growth may develop slipped capital femoral epiphyses more frequently; evaluate any child with new onset of a limp or with complaints of hip or knee pain.
Disease-related concerns:
• Acute critical illness: Initiation of somatrogon is contraindicated with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure; mortality may be increased. Safety of continuing growth hormone products used at lower doses (eg, for replacement therapy) has not been established during critical illness.
• Hypoadrenalism: Patients who have or are at risk for pituitary hormone deficiency(ies) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism with growth hormone therapy; patients with previously diagnosed hypoadrenalism may require increased dosages of glucocorticoids due to the effects of growth hormone.
• Hypothyroidism: Patients who have or are at risk for pituitary hormone deficiency(ies) may be at risk for unmasking of central hypothyroidism with growth hormone therapy. Untreated/undiagnosed hypothyroidism may decrease response to therapy, particularly the growth response in children.
• Prader-Willi syndrome: Sudden death has been reported in pediatric patients with Prader-Willi syndrome following the use of growth hormone. The reported fatalities occurred in patients with 1 or more risk factors, including severe obesity, history of upper airway obstruction or sleep apnea, respiratory impairment, or unidentified respiratory infection; male patients may be at greater risk. Use of somatrogon is not indicated in patients with Prader-Willi syndrome.
• Scoliosis: Progression of scoliosis may occur in children experiencing rapid growth.
Special populations:
• Pediatric: Failure to increase growth rate, particularly during the first year of therapy, indicates need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Ngenla: 24 mg/1.2 mL (1.2 mL); 60 mg/1.2 mL (1.2 mL) [latex free; contains metacresol]
No
Solution Pen-injector (Ngenla Subcutaneous)
24 mg/1.2 mL (per mL): $1,992.00
60 mg/1.2 mL (per mL): $4,980.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Pen-injector, Subcutaneous:
Ngenla: 24 mg/1.2 mL (1.2 mL); 60 mg/1.2 mL (1.2 mL) [contains metacresol]
SUBQ: Do not use if solution is cloudy, dark yellow, or contains flakes or particles; only use if colorless to slightly yellow with no visible particles/flakes. Do not shake. Administer by SUBQ injection only; not for IV injection. Prior to first use, each new pen must be primed; the 24 mg prefilled pen is primed with 0.4 mg, and the 60 mg prefilled pen is primed with 1 mg; see manufacturer's labeling for specific priming procedure and additional administration instructions. Once primed, set dose knob to appropriate dose, insert needle into clean skin, and activate device by holding the button down; continue to hold the button until the dose window reads "0." After the dose returns to "0," continue to hold the needle in the skin for 10 seconds to ensure the dose has been administered. Multiple injections may be required for the full dose; the 24 mg prefilled pen (20 mg/mL) will administer up to 12 mg per injection in 0.2 mg increments, and the 60 mg prefilled pen (50 mg/mL) will administer up to 30 mg per injection in 0.5 mg increments. If the dose is greater than pen size allows (or greater than the amount left in the pen), additional pens will be needed to administer the full dose. For more comfortable injections, allow pen to sit at room temperature up to 30 minutes prior to injection. Administer into the abdomen (do not use within 2 inches of belly button), front of middle thigh, buttock, or outer area of upper arm; do not rub injection site after administration. Administer on the same day each week; rotate injection site weekly. If more than one injection is required to deliver the full dose, administer each injection at a different injection site using a new sterile 31- or 32-gauge, 8 mm needle for each injection. Day of weekly administration may be changed (if necessary) as long as the time between doses is >72 hours. Discard pen after 5 uses, 28 days after first use, or if it has been left out of the refrigerator for >2 hours, even it is not empty.
Missed dose:
≤3 days since missed dose: Administer as soon as possible and then resume regular once-weekly dosing schedule.
>3 days since missed dose: Skip missed dose and administer next dose on the regularly scheduled day.
Store at 2°C to 8°C (36°F to 46°F); do not freeze. Keep in outer carton to protect from light prior to first use. Pens in use may be stored at 2°C to 8°C (36°F to 46°F) for up to 28 days; do not freeze or shake. Protect from heat and direct sunlight. Discard unused portion or if frozen.
Note: Not approved in the United States.
Canadian labeling: Treatment of growth failure due to inadequate endogenous growth hormone secretion (indicated for use in ages 3 to 11 years of age).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Corticosteroids (Systemic): May diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Corticosteroids (Systemic). Risk C: Monitor therapy
Cortisone: May diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of Cortisone. Risk C: Monitor therapy
Estrogen Derivatives: May diminish the therapeutic effect of Growth Hormone Analogs. Management: Initiate somapacitan at 2 mg once weekly in patients receiving oral estrogens. Monitor for reduced efficacy of growth hormone analogs; increased doses may be required. Risk D: Consider therapy modification
Macimorelin: Products that Affect Growth Hormone may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination
PredniSONE: May diminish the therapeutic effect of Growth Hormone Analogs. Growth Hormone Analogs may decrease serum concentrations of the active metabolite(s) of PredniSONE. Risk C: Monitor therapy
Somatrogon has the potential to interfere with hCG pregnancy testing (false positives or false negatives); alternative methods are preferred.
Adverse events were not observed in animal reproduction studies.
Growth response, serum insulin-like growth factor-1 (IGF-1), progression of scoliosis in patients with a history of scoliosis, clinical evidence of slipped capital femoral epiphysis (such as a limp or hip or knee pain), thyroid function, glucose in patients with risk factors for glucose intolerance, changes in appearance of birthmarks or moles. In addition, guidelines recommend a physical exam at every visit; adrenal and thyroid function in patients with growth hormone deficiency due to multiple pituitary hormone deficiencies; funduscopic exam if symptoms of intracranial hypertension occur (PES [Grimberg 2016]). Monitor for hypersensitivity reactions.
Insulin-like growth factor-1 (IGF-1): Measure 4 days prior to next scheduled dose. Keep within 2 standard deviation scores of upper normal range.
Somatrogon is a glycoprotein of recombinant DNA origin; it contains the sequence of amino acids with one copy of the C-terminal peptide found in human growth hormone. Somatrogon binds to the growth hormone receptor initiating changes in growth and metabolism and has also been shown to increase insulin-like growth factor serum concentrations.
Distribution: Pediatric patients: Vd: 0.812 L/kg.
Metabolism: Protein catabolism.
Half-life elimination: Pediatric patients: 28.3 hours.
Time to peak: SUBQ: Pediatric patients: 6 to 18 hours.
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