Somapacitan-Beco Dosage

Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.

Usual Adult Dose for Adult Human Growth Hormone Deficiency

Initial dose: 1.5 mg subcutaneously once weekly

• Adjust dosage every 2 to 4 weeks by approximately 0.5 to 1.5 mg until desired response is achieved.
• Titrate based on clinical response and serum insulin-like growth factor (IGF-I, drawn 3 to 4 days after the prior dose).
• Decrease dosage as needed based on adverse reactions and/or IGF-I above age- and sex-specific normal ranges.

Maximum dose: 8 mg once weekly

Comments:

• Therapy should be supervised by a physician experienced in diagnosis and management of growth hormone deficiency.

Use: Replacement of endogenous growth hormone in adults with growth hormone deficiency.

Usual Geriatric Dose for Adult Human Growth Hormone Deficiency

Initial dose: 1 mg subcutaneously once weekly
Maximum dose: 8 mg once weekly

Comments:

• Therapy should be supervised by a physician experienced in diagnosis and management of growth hormone deficiency.
• Older subjects appear to have higher exposure than younger subjects at the same dose.
• Use smaller increments when increasing the dose.

Use: Replacement of endogenous growth hormone in adults with growth hormone deficiency.

Usual Pediatric Dose for Pediatric Growth Hormone Deficiency

Initial dose: 0.16 mg/kg subcutaneously once weekly based on actual body weight

Comments:

• Therapy should be supervised by a physician experienced in diagnosis and management of growth hormone deficiency.
• Adjust the dosage individually for each patient based on their growth response.
• When transitioning from daily human growth hormone to the once-weekly regimen of this drug, choose the preferred day for the weekly dose.
• Administer the final dose of the daily treatment on the day preceding (or at least 8 hours before) the initial dose of this drug.
• If switching from a weekly human growth hormone regimen to once-weekly regimen of this drug, maintain the once-weekly dosing schedule.
• In cases where patients do not experience an increase in height velocity, especially during the initial year of treatment, assess compliance and explore other potential factors like hypothyroidism, undernutrition, advanced bone age, and the presence of antibodies to recombinant human growth hormone.
• Patients previously treated with this drug for growth hormone deficiency during childhood, and whose growth plates have closed, should undergo reevaluation before continuing this treatment.

Use: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver impairment: No adjustment recommended.
Moderate liver impairment:

• Adult: Initiate at 1 mg once weekly; use smaller increments when increasing dose; maximum dose of 4 mg once weekly.
• Pediatric: Not recommended

Severe liver impairment: Not recommended; use has not been studied.

Dose Adjustments

Women receiving oral estrogen:
Initial dose: 2 mg subcutaneously once weekly
Maximum dosage: 4 mg once weekly

• Use smaller increments when increasing dosage.

Precautions

CONTRAINDICATIONS:

• 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 this drug.
• Hypersensitivity to this drug or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin.
• Pediatric patients with closed epiphyses
• Active malignancy
• Active proliferative or severe non-proliferative diabetic retinopathy
• Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death

Safety and efficacy have not been established in patients younger than 2.5 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer subcutaneously in the abdomen or thigh; rotate injection sites regularly to avoid lipohypertrophy.
• Inspect product for particulates and discoloration (should be clear to slightly opalescent and colorless to slightly yellow); do not use if cloudy or particulate matter is present.
• The prefilled pen dials in 0.05 mg increments for doses from 0.05 to 4 mg.
• Missed doses as soon as possible and not more than 3 days/72 hours after missed dose.
• If more than 3 days have passed since a missed dose, skip the dose and administer next dose on regular dosing day.

Storage requirements:
Before first use (unopened):

• Refrigerate at 36F to 46F (2C to 8C) until expiration.
• Can be stored at room temperature up to 77F (25C) for maximum of 3 days.

After first use (opened):

• Refrigerate at 36F to 46F (2C to 8C) for up to 6 weeks.
• Can be stored at room temperature up to 77F (25C) for maximum of 3 days.

The total time allowed at room temperature (up to 77F [25C]) is 72 hours (3 days) regardless of whether the product is in-use (opened) or before first use (unopened).

General storage requirements:

• Refrigerate with cap on and in the original carton to protect from light.
• Do not freeze; do not use if product has been frozen.
• Discard if pen is kept above 86F (30C).
• Avoid direct or excessive heat.
• Avoid sunlight.

Monitoring:

• Perform fundoscopic examination prior to treatment and periodically thereafter to exclude papilledema; if identified prior to treatment, evaluate the etiology and treat appropriately prior to therapy.

Patient advice:

• Advise patients to read the FDA approved Patient Information and Instructions for Use.
• Patients and/or caregivers should be instructed to administer this drug once a week.
• Hypersensitivity: Patients and/or caregivers need to be aware that severe and potentially serious systemic hypersensitivity reactions, such as anaphylaxis and angioedema, have been reported. In the event of an allergic reaction, immediate medical attention should be sought.
• Neoplasms: Patients should be advised to promptly report any noticeable changes in skin pigmentation or alterations in the appearance of preexisting moles.
• Glucose Intolerance/Diabetes Mellitus: Patients should be informed that new-onset prediabetes or diabetes mellitus may occur, or preexisting diabetes may worsen while undergoing this treatment. Monitoring of blood glucose levels during this therapy may be necessary.
• Intracranial Hypertension: Patients should be instructed to promptly inform their healthcare provider if they experience any visual changes, headaches, nausea, and/or vomiting.
• Fluid Retention: Patients should be made aware that fluid retention is a common occurrence during this replacement therapy. They should be educated about the clinical signs of fluid retention, such as swelling, joint pain, muscle pain, and nerve compression syndromes, including carpal tunnel syndrome and paresthesia. If any of these signs or symptoms manifest during this treatment, patients should report them to their healthcare provider.
• Hypoadrenalism: Patients who currently have or are at risk of corticotropin deficiency should be advised that hypoadrenalism may develop. They should be encouraged to report hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss to their healthcare provider.
• Hypothyroidism: Patients and caregivers should be informed that undiagnosed or untreated hypothyroidism can hinder an optimal response to this treatment. Therefore, patients may need periodic thyroid function tests.
• Pancreatitis: Patients should be aware that pancreatitis may develop and should promptly report any new-onset abdominal pain to their healthcare provider.
• Lipohypertrophy/Lipoatrophy: Patients should understand that administering this drug subcutaneously at the same site over an extended period can lead to lipohypertrophy or lipoatrophy. To reduce this risk, patients should be advised to rotate injection sites when administering this drug.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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