Somapacitan Application Scope

Somapacitan, marketed under the brand name Sogroya®, is a long-acting human growth hormone analog indicated for:

Pediatric Patients: Treatment of growth failure due to inadequate secretion of endogenous growth hormone (GH) in patients aged 2.5 years and older.
Adults: Replacement of endogenous GH in adults with growth hormone deficiency (GHD).

Characteristics of Somapacitan

Ingredients: Somapacitan-beco is a human growth hormone (hGH) analog.
Properties: Somapacitan binds to GH receptors, stimulating the production of insulin-like growth factor 1 (IGF-1), which mediates many of the effects of GH. Its prolonged half-life allows for once-weekly administration.
Specification: Available as a solution for subcutaneous injection in prefilled pens delivering doses of 5 mg/1.5 mL, 10 mg/1.5 mL, or 15 mg/1.5 mL.
Packaging Specification: Supplied in single-patient-use prefilled pens with specific color coding for each dosage strength.
Storage: Store refrigerated at 2°C to 8°C (36°F to 46°F). After first use, pens can be stored at room temperature up to 25°C (77°F) for up to 6 weeks.
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Approved by the FDA for the treatment of GHD in adults and pediatric patients.
Approval Number: FDA approval granted on August 28, 2020.
Date of Revision: Refer to the latest prescribing information for the most current revision date.
Manufacturer: Novo Nordisk.

Dosage and Administration:
- Adults with GHD: Initiate with 1.5 mg administered once weekly by subcutaneous injection. Adjust dosage based on clinical response and serum IGF-1 concentrations, not exceeding 8 mg once weekly.
- Pediatric Patients with GHD: Initiate with 0.16 mg/kg body weight administered once weekly by subcutaneous injection. Adjust dosage based on clinical response and serum IGF-1 concentrations, not exceeding 0.16 mg/kg once weekly.
Adverse Reactions:
- Common adverse reactions in adults include back pain, arthralgia, diarrhea, headache, and injection site reactions. In pediatric patients, common adverse reactions include pyrexia, injection site reactions, and vomiting.
Contraindications:
- Acute critical illness, active malignancy, hypersensitivity to somapacitan or any of its excipients, and diabetic retinopathy.
Precautions:
- Monitor for glucose intolerance, intracranial hypertension, and progression of preexisting scoliosis.
- In pediatric patients, monitor thyroid function and adjust thyroid hormone replacement therapy as needed.

Drug Interactions:
- May decrease insulin sensitivity; monitor blood glucose levels in patients with diabetes mellitus.
- May alter the clearance of drugs metabolized by the cytochrome P450 system; monitor patients on concomitant medications metabolized by this pathway.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.