Somatrogon Dosage

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Usual Pediatric Dose for Pediatric Growth Hormone Deficiency

Recommended dose in patients aged 3 years and older: 0.66 mg/kg based on actual body weight given once a week by subcutaneous injection

Comments:

• Administer on the same day each week at any time of day.
• Subcutaneous injection may be given in abdomen, thighs, buttocks, or upper arms; rotate site weekly.
• Perform fundoscopic examination prior to treatment to exclude papilledema.
• Dosage should be individualized based on growth response.

Use: For the treatment of pediatric patients aged 3 years and older who have growth failure
due to an inadequate secretion of endogenous growth hormone.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those

with acute respiratory failure due to the risk of increased mortality with somatropin

• Hypersensitivity to this drug or any of the product excipients
• Closed epiphyses
• Active malignancy due to the risk of malignancy progression
• Active proliferative or severe non-proliferative diabetic retinopathy
• Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep

apnea or have severe respiratory impairment due to the risk of sudden death

Safety and efficacy have not been established in patients younger than 3 years of age.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The manufacturer product information should be consulted prior to product administration.
• Inspect solution in pre-filled pen prior to administration; do not use if flakes, particles, or discoloration is observed.
• Do not shake pen; shaking can damage product.
• Day of weekly administration can be changed if the time between 2 doses is separated by at least 3 days (72 hours); weekly dosing should be continued thereafter.
• If switching from a once a day growth hormone treatment, initiate this drug on the day after the last daily injection, and then continue once a week.
• Use different injection sites if more than one injection is required to deliver a complete dose.
• Pen should not be used for more than 28 days after first use; return to refrigeration after each use.
• Missed dose recommendations:
• Administer as soon as possible within 3 days of missed dose.
• If more than 3 days have passed, skip missed dose and administer next dose on regularly scheduled day.

Storage requirements:

• Before first use: Store refrigerated at 36F to 46F (2C to 8C) in the original carton.
• After first use: Store the pen refrigerated at 36F to 46F (2C to 8C) between each use, for up to 28 days.
• Protect from light.
• Do not freeze or expose to heat.
• Do not use if product has been frozen, dropped, or damaged.
• Do not shake.

Product priming and administration techniques:

• This product is available as a multi-dose prefilled pen for single-patient use.
• Pen may be used straight from refrigerator; to minimize discomfort, leave pen at room temptation for up to 30 minutes prior to injection.
• New prefilled pens require priming before first use by ejecting a small amount of drug (liquid) from needle.
• Set up delivery dose by dialing pen knob in increments up to patient dose.
• Remove pen cap from pen only when ready to inject and always use a new pen needle for each injection.
• When injecting, press plunger for 10 seconds; do not inject into bony areas.
• Recap pen when finished or not in use; return pen to refrigerator.
• Write date of first use on pen and discard when empty or after 28 days.

General:

• Treatment should be supervised by a healthcare provider experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency.
• If papilledema is identified, evaluate etiology and treat underlying cause prior to starting treatment.
• Do not initiate or continue treatment if there is evidence of epiphyseal growth plate closure.

Monitoring:

• Assess blood glucose periodically to monitor for glucose intolerance or new onset diabetes.
• Ensure rotation of injection sites and monitor skin for lipoatrophy.
• Periodically perform fundus examination to assess for papilledema.
• Review skin and nevi for neoplastic changes.
• In general, assess patient for new or recurrent malignancies during treatment.
• Evaluate thyroid function periodically during treatment.

Patient advice:

• Read the FDA-approved patient labeling (Medication Guide).
• Refer patients to the Instructions for Use for complete administration information.
• Recommend that patients rotate injection sites when administering this medication.
• Instruct patients to report skin changes or changes to preexisting nevi.
• Inform patients monitoring of blood glucose is recommended.
• Advise patients to promptly report any visual changes, headache, and nausea/vomiting.
• Alert patients to the recommendation of periodic thyroid function tests.

Further information

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

Medical Disclaimer