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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:
-Advise patients to read the FDA approved Patient Information and Instructions for Use.

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