Active Ingredient: Sotatercept
Sotatercept is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.3 milligrams sotatercept per kilogram of body weight, once every 3 weeks. Afterwards, subcutaneous, 0.7 milligrams sotatercept per kilogram of body weight, once every 3 weeks.
Sotatercept is administered once every 3 weeks by subcutaneous injection according to patient body weight. The starting dose of sotatercept is 0.3 mg/kg.
Obtain hemoglobin (Hgb) and platelet count prior to the first dose of sotatercept. Do not initiate treatment if platelet count is <50,000/mm³ (<50 × 109/L).
Inhjection Volume (mL) = Weight (kg) x 0.3 mg/kg / 50 mg/mL
Injection volume for starting dose is calculated based on patient weight as follows:
Injection volume should be rounded to the nearest 0.1 mL.
For example: (70 kg x 0.3 mg/kg) ÷ 50 mg/mL = 0.42 mL, rounds to 0.4 mL
After verifying acceptable Hgb and platelet count, increase to the target dose of 0.7 mg/kg. Continue treatment at 0.7 mg/kg every 3 weeks unless dosage adjustments are required.
Injection volume for target dose is calculated based on patient weight as follows:
Inhjection Volume (mL) = Weight (kg) x 0.7 mg/kg / 50 mg/mL
Injection volume should be rounded to the nearest 0.1 mL.
For example: (70 kg x 0.7 mg/kg) ÷ 50 mg/mL = 0.98 mL, rounds to 1 mL
If a dose of sotatercept is missed, administer as soon as possible. If the missed dose of sotatercept is not administered within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals. In case of an overdose, monitor for erythrocytosis.
Check Hgb and platelet count before each dose for the first 5 doses, or longer if values are unstable. Thereafter, monitor Hgb and platelet count periodically.
Delay treatment for at least 3 weeks if any of the following occur:
Recheck Hgb and platelet count before reinitiating treatment. For treatment delays lasting >9 weeks, restart treatment at 0.3 mg/kg, and escalate to 0.7 mg/kg after verifying acceptable Hgb and platelet count.
Select the injection site on the abdomen (at least 2 inches away from navel), upper thigh, or upper arm, and swab with an alcohol wipe. Select a new site for each injection that is not scarred, tender, or bruised.
For administration by the patient or caregiver, use only the abdomen and upper thigh.
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