Pulmonary arterial hypertension

Active Ingredient: Sotatercept

Indication for Sotatercept

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

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:

0.3 mg/kg as a single starting dose for 3 weeks and thereafter 0.7 mg/kg once every 3 weeks

For:

Dosage regimens

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.

Detailed description

Sotatercept is administered once every 3 weeks as a single subcutaneous injection according to patient weight.

Recommended starting dose

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.

Recommended target dose

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.

Dose adjustments due to increase in haemoglobin or decreased platelet count

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 increases >1.24 mmol/L (2 g/dL) from the previous dose and is above the ULN.
  • Hgb increases >2.48 mmol/L (4 g/dL) from baseline.
  • Hgb increases >1.24 mmol/L (2 g/dL) above ULN.
  • Platelet count decreases <50 × 109/L.

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.

Missed dose

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.

Dosage considerations

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.

Active ingredient

Sotatercept

Sotatercept is an activin signalling inhibitor with high selectivity for Activin-A, a dimeric glycoprotein which belongs to the transforming growth factor-β (TGF-β) superfamily of ligands. Activin-A binds to the activin receptor type IIA (ActRIIA) regulating key signalling for inflammation, cell proliferation, apoptosis, and tissue homeostasis.

Read more about Sotatercept

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