Somatrogon Dosage
Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.
Applies to the following strengths: ghla 24 mg/1.2 mL; ghla 60 mg/1.2 mL
Usual Pediatric Dose for:
Additional dosage information:
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
- 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
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.
More about somatrogon
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- Drug class: growth hormones
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