SKYTROFA Powder for solution for injection Ref.[28361] Active ingredients: Lonapegsomatropin

2.1 General Dosing Information

• For subcutaneous injection, once-weekly.
• Therapy with SKYTROFA should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure due to growth hormone deficiency (GHD).
• To exclude preexisting papilledema, perform fundoscopic examination before initiating treatment with SKYTROFA and reassess periodically thereafter [see Warnings and Precautions (5.5)].

2.2 Dosage Recommendations

• The recommended dose of SKYTROFA for treatment-naïve patients and patients switching from daily somatropin therapy is 0.24 mg/kg body weight, given once-weekly.
• Individualize and titrate the dosage of SKYTROFA based on response.
• When changing from daily somatropin therapy to once-weekly SKYTROFA, wait at least 8 hours between the final dose of daily somatropin and the first dose of once-weekly SKYTROFA.
• Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment.
• Discontinue SKYTROFA once epiphyseal fusion has occurred.

2.3 Missed Doses

• Administer a missed dose as soon as possible and not more than 2 days after the missed dose.
• To avoid missed doses, SKYTROFA can be taken 2 days before or 2 days after the scheduled dosing day. Resume once-weekly dosing for the next dose at the previously scheduled dosing day.
• If more than 2 days have passed from the scheduled day, skip the dose and administer the next dose on the regularly scheduled day.
• At least 5 days should elapse between doses.

2.4 Administration Instructions

SKYTROFA is available in 9 cartridges (dosage strengths in somatropin equivalents). Selection of the appropriate cartridge is based on the prescribed dose (mg/kg) and the patient’s body weight (kg).

• If prescribing a dose of 0.24 mg/kg/week and the patient’s weight is 11.5 to 100 kg, follow the recommended dosing in Table 1.
• If prescribing a dose other than 0.24 mg/kg/week, calculate the total weekly dose (in mg) and select the appropriate cartridge as follows:
  • Total weekly dose (mg) = prescribed weekly dose (mg/kg) × patient’s body weight (kg).
  • Round the total weekly dose (mg) to the closest cartridge dose while also considering treatment goals and clinical response.

Table 1. Recommended Dosing for Patients Prescribed Doses of 0.24 mg/kg/week:

2.5 Preparation and Administration

• The SKYTROFA cartridge has been designed for use only with the SKYTROFA Auto-Injector.
• If refrigerated, the SKYTROFA cartridge must be kept at room temperature for 15 minutes before use.
• The SKYTROFA Auto-Injector provides a fully automated reconstitution of the lyophilized drug product which is followed by a manual mixing step controlled by the device. When the injection needle is inserted into the skin, the device automatically delivers the drug product. The built-in electronics and software assist the user during the entire preparation and injection sequence and provide confirmation that the full dose has been delivered.
• The mixed solution should be clear and colorless to opalescent and may occasionally contain air bubbles. DO NOT inject if the solution is cloudy or contains particulate matter.
• Use SKYTROFA cartridges within 4 hours after reconstitution. Discard reconstituted SKYTROFA cartridges after 4 hours when stored at room temperature up to 86°F (30°C).
• Inject SKYTROFA subcutaneously into the abdomen, buttock, or thigh. Rotate injection sites between and within regions to reduce the risk of lipoatrophy.
• Refer to the Instructions for Use for complete administration instructions with illustrations. The instructions can also be found on www.Skytrofa.com/IFU.

Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin may cause fluid retention. Long-term overdosage may result in signs and symptoms of gigantism consistent with the known effects of excess growth hormone.

For patients

Refrigerate SKYTROFA cartridges at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. Do not freeze. Alternatively, SKYTROFA outer carton containing blistered cartridges may be stored at room temperature [up to 86°F (30°C)] for up to 6 months and can be returned to refrigeration within the 6 months. Write the date first removed from the refrigerator in the space provided on the outer carton. Do not use SKYTROFA beyond the expiration date or 6 months after the date it was first removed from refrigeration (whichever is earlier).

For pharmacy long-term storage

Store SKYTROFA cartridges refrigerated at 36°F to 46°F (2°C to 8°C) in the outer carton to protect from light until the expiration date. Do not freeze.