Somapacitan-beco

What Is somapacitan-beco?

• 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.

What are the uses of this medicine?

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

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• 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

What are the dosage forms and brand names of this medicine?

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

• SOGROYA

What side effects can this medication cause?

Common possible side effects of this medicine include:

• back pain
• arthralgia
• dyspepsia
• sleep disorder
• dizziness
• tonsillitis
• peripheral edema
• vomiting
• adrenal insufficiency
• hypertension
• blood creatine phosphokinase increase
• weight increase
• anemia

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

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

• 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.

Can this medicine be used in pregnancy?

• There are no available data on SOGROYA use in pregnant women.

Can this medicine be used in children?

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

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Somapacitan-beco
• FDA Somapacitan-beco

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