Active Ingredient: Sotatercept
Sotatercept, in combination with other pulmonary arterial hypertension (PAH) therap ies, is indicated for the treatment of PAH in adult patients with WHO Functional Class (FC) II to III, to improve exercise capacity.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.3 milligrams sotatercept per kilogram of body weight, 1 one dose, over the duration of 3 weeks. Afterwards, subcutaneous, 0.7 milligrams sotatercept per kilogram of body weight, once every 3 weeks.
Sotatercept is administered once every 3 weeks as a single subcutaneous injection according to patient weight.
Haemoglobin (Hgb) and platelet count should be obtained prior to the first dose. Initiation of treatment is contraindicated if platelet count is consistently <50 × 109/L.
Treatment is initiated with a single dose of 0.3 mg/kg.
Three weeks after a single starting dose of 0.3 mg/kg, the dose should be escalated to the recommended target dose of 0.7 mg/kg after verifying acceptable Hgb and platelet count. Treatment should be continued at 0.7 mg/kg every 3 weeks unless dose adjustments are required.
Hgb and platelet count should be monitored for the first 5 doses, or longer if values are unstable. Thereafter, Hgb and platelet count should be verified every 3 to 6 months and the dose adjusted if necessary.
Treatment should be delayed for 3 weeks (i.e., one dose delay) if any of the following occur:
Hgb and platelet count should be obtained again before reinitiating treatment.
For treatment delays lasting >9 weeks, treatment should be restarted at 0.3 mg/kg, and the dose should be escalated to 0.7 mg/kg after verifying acceptable Hgb and platelet count.
For treatment delays lasting >9 weeks due to platelet counts consistently <50 × 109/L, the physician should carry out a benefit/risk re-evaluation for the patient before reinitiating treatment.
If a dose is missed, administer as soon as possible. If the missed dose is not taken within 3 days of the scheduled date, adjust the schedule to maintain 3-week dosing intervals.
Sotatercept should be administered by subcutaneous injection in the abdomen (at least 5 cm away from navel), upper arm, or upper thigh. It should not be injected into sites that are scarred, tender, or bruised. The same injection site should not be used on two consecutive injections.
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