(somatrogon-ghla)

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing and Administration Information

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NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency (GHD) [see Indications and Usage (1)].
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Refer patient to the Instructions for Use for complete administration instructions.
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Administer NGENLA by subcutaneous injection, once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms. Rotate the injection site weekly.
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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If flakes, particles or discoloration are observed, do not use the pen. Do not shake; shaking can damage the product.
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Prefilled pens deliver somatrogon-ghla in 0.2 mg or 0.5 mg increments.

2.2 Perform Fundoscopic Examination Prior to Initiation of NGENLA

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Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating treatment with NGENLA [see Warnings and Precautions (5.4)].

2.3 Recommended Dosage and Monitoring for Pediatric Patients with GHD

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Recommended dosage of NGENLA is 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection.
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Individualize dosage for each patient based on the growth response.
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The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued.
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When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection.
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If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site.

2.4 Missed Dose

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If a dose is missed, administer NGENLA as soon as possible within 3 days after the missed dose.
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If more than 3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
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