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Sogroya Dosage

Generic name: SOMAPACITAN 3.3mg in 1mL
Dosage form: injection, solution
Drug class: Growth hormones

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Administration and Use Instructions

Therapy with SOGROYA should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which SOGROYA is indicated [see Indications and Usage (1)].
Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema, and periodically thereafter. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating therapy with SOGROYA [see Warnings and Precautions (5.4)].
Administer SOGROYA by subcutaneous injection to the abdomen or thigh with regular rotation of injection sites to avoid lipohypertrophy.
Inspect visually for particulate matter and discoloration. SOGROYA should be a clear to slightly opalescent and colorless to slightly yellow solution. If the solution is cloudy or contains particulate matter do not use.
The SOGROYA 5 mg/1.5 mL (3.3 mg/mL) prefilled pen dials in 0.025 mg increments and delivers doses from 0.025 mg to 2 mg.
The SOGROYA 10 mg/1.5 mL (6.7 mg/mL) prefilled pen dials in 0.05 mg increments and delivers doses from 0.05 mg to 4 mg.
Instructions for delivering the dosage are provided in the PATIENT INFORMATION and INSTRUCTIONS FOR USE leaflets enclosed with the SOGROYA prefilled pen.

Recommended Dosage, Titration, and Monitoring

Administer the prescribed dose subcutaneously one time each week (weekly).
Initiate SOGROYA with a dosage of 1.5 mg once weekly for treatment naïve patients and patients switching from daily growth hormone (somatropin).
Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response is achieved.
Titrate the dosage based on clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations. Draw IGF-1 samples 3 to 4 days after the prior dose.
Decrease the dosage as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range.
The maximum recommended dosage is 8 mg once weekly.

Recommended Dosage and Titration for Specific Populations

Patients Aged 65 Years and Older

Initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage [see Use in Specific Populations (8.5)]. See above for monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration (2.2)].

Patients with Hepatic Impairment

SOGROYA is not recommended in patients with severe hepatic impairment.
For patients with moderate hepatic impairment, initiate SOGROYA with a dosage of 1 mg once weekly and use smaller dose increment increases when titrating the dosage. See above for monitoring recommendations [see Dosage and Administration (2.2)]. The maximum recommended dosage is 4 mg once weekly.
No dosage adjustment is recommended for patients with mild hepatic impairment.

Women Receiving Oral Estrogen

Initiate SOGROYA with a dosage of 2 mg once weekly [see Drug Interactions (7)]. See above for titration and monitoring recommendations and the maximum recommended dosage of SOGROYA [see Dosage and Administration (2.2)].

Missed Doses

Administer a missed dose as soon as possible and not more than 3 days after the missed dose (72 hours).
If more than 3 days have passed since the missed dose, skip the dose and administer the next dose on the regular dosing day.

Further information

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