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.

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

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

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.

• 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.

• 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.

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