Somapacitan-Beco Dosage

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 once weekly

Comments:

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.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver impairment: No adjustment recommended.
Moderate liver impairment: Initiate at 1 mg once weekly; use smaller increments when increasing dose; maximum dose of 4 mg once weekly.
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 or abdominal surgery, multiple accidental trauma, or acute respiratory failure due to risk of increased mortality with use of pharmacological doses of this drug
Active malignancy
Hypersensitivity to any of the ingredients; systemic hypersensitivity reactions have occurred with other growth hormone products
Active proliferative or severe non-proliferative diabetic retinopathy

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in these patients.

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:

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: