Somapacitan-beco

What Is somapacitan-beco?[edit | edit source]

somapacitan-beco (SOGROYA) is a drug for replacement of growth hormone in adults with growth hormone deficiency (GHD).
GHD is a condition when body doesn’t produce enough growth hormone on its own. Growth hormone regulates many functions in the body including accumulation of fat in the trunk or central area of the body that can be associated with serious medical issues.

This medicine is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (GHD).

Somapacitan-beco binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects.

This medicine cannot be used in patients with:

Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA
Active malignancy
Hypersensitivity to SOGROYA or any of its excipients
severe non-proliferative diabetic retinopathy

Administer by subcutaneous injection to the abdomen or thigh with regular rotation of injection sites to avoid lipohypertrophy/lipoatrophy.
Administer the prescribed dose subcutaneously one time each week
Initiate SOGROYA with a dosage of 1.5 mg once weekly
Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response has been achieved
The maximum recommended dosage is 8 mg once weekly
Titrate the dosage based on clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations

This medicine is available in fallowing doasage form:

As Injection: 10 mg/1.5 mL (6.7 mg/mL) somapacitan-beco single-patient-use prefilled pen

This medicine is available in fallowing brand namesː

Common possible side effects of this medicine include:

SOGROYA may cause serious side effects including:

Increased risk of growth of cancer that is already present and increased risk of the return of cancer
New or worsening high blood sugar
Increased intracranial pressure (pressure in the skull)
Serious allergic reactions
Body fluid retention
Decreased adrenal and thyroid gland function
Inflammation of pancreas and
Loss of fat tissue at the injection site

Monitor patients with preexisting tumors for progression or recurrence.
SOGROYA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving SOGROYA, especially in patients with existing diabetes mellitus or at risk for its development.
Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with SOGROYA, stop treatment.
In the event of an allergic reaction, seek prompt medical attention.
Fluid Retention may occur in adults.
Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism.
Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of SOGROYA.
Consider pancreatitis in patients with persistent severe abdominal pain.
Lipohypertrophy occur if SOGROYA administered in the same location over a long period of time. Rotate injection sites on a regular basis.

Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia.
Overdose with SOGROYA is likely to cause fluid retention.
Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess endogenous growth hormone.

The safety and effectiveness of SOGROYA have not been established in pediatric patients.

Before and during use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) with the cap on and in the original carton to protect from light.
Do not freeze.
Do not use SOGROYA if it has been frozen.
Discard prefilled pen if kept above 86°F (30°C).
Avoid direct or excessive heat.
Avoid sunlight.
Write the date of first use in the space provided on the carton.
Always remove and safely discard the needle after each injection and store the SOGROYA prefilled pen without an injection needle attached.
Always use a new needle for each injection to prevent contamination.

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