Skytrofa Dosage

General Dosing Information

• For subcutaneous injection, once weekly.
• Therapy with SKYTROFA should be supervised by a healthcare provider who is experienced in the diagnosis and management of patients with growth hormone deficiency (GHD).
• Perform fundoscopic examination before initiating treatment with SKYTROFA to exclude preexisting papilledema. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating treatment with SKYTROFA.

Recommended Dosage for Pediatric Patients

• ​The recommended dose of SKYTROFA for treatment-naïve patients and patients switching from another growth hormone product 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 SKYTROFA.
• ​When changing from another once-weekly growth hormone therapy to once-weekly SKYTROFA, wait at least 7 days between the final dose of the previous growth hormone therapy and the first dose of 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.
• Patients who were treated with SKYTROFA for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuing SKYTROFA.

Recommended Dosage for Adults

• ​The recommended starting dose of SKYTROFA in adults with GHD is based on age and concomitant use of oral estrogen. For treatment-naïve patients or for patients switching from another growth hormone product, start SKYTROFA as described below:
  • ​1.4 mg once weekly for adults 30 to 60 years old, with no oral estrogen intake
  • ​2.1 mg once weekly for adults under 30 years old, or adults of any age intaking oral estrogen
  • ​0.7 mg once weekly for adults over 60 years old, with no oral estrogen intake
• ​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 SKYTROFA.
• ​When changing from another once-weekly growth hormone therapy to once-weekly SKYTROFA, wait at least 7 days between the final dose of the previous growth hormone therapy and the first dose of SKYTROFA.
• ​Increase the dose monthly to a higher strength cartridge based on the clinical response and/or IGF-1 concentration. Draw IGF-1 serum sample 4 to 5 days after the prior dose.
• ​Decrease the dose to a lower strength cartridge as needed based on adverse reactions or a weekly average IGF-1 concentration above the age- and sex-specific normal range.
• ​The maximum recommended dose is 6.3 mg once weekly.

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.

Administration Instructions for Pediatric Patients

SKYTROFA is available in 9 cartridges (dosage strengths in somatropin equivalents) for pediatric patients.

Selection of the appropriate cartridge (mg) 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.

Administration Instructions for Adults

​SKYTROFA is available in 14 cartridges (dosage strengths in somatropin equivalents) for adults.

​Selection of the appropriate cartridge (mg) is based on the prescribed dose (mg/week).

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. The solution may contain air bubbles and this is acceptable. 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.
• ​Patients and/or caregivers who will administer SKYTROFA should receive appropriate training and instruction on the proper use of SKYTROFA from their healthcare provider.