Sotatercept interacts in the following cases:
No dose adjustment is required based on hepatic impairment (Child-Pugh Classification A to C). Sotatercept has not been studied in patients with hepatic impairment.
Sotatercept has not been studied in PAH patients with severe renal impairment (estimated glomerular filtrati on rate (eGFR) <30 mL/min/1.73m²).
Based on findings in animals, sotatercept may impair female and male fertility.
There are no data from the use of sotatercept in pregnant women. Studies in animals have shown reproductive toxicity (increases in post-implantation losses, reduction in foetal body weights, and delays in ossification).
Sotatercept is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether sotatercept/metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded.
Breast-feeding should be discontinued during treatment and for 4 months after the last dose of treatment.
Pregnancy testing is recommended for women of childbearing potential before starting treatment. Women of childbearing potential should use effective contraception during treatment and for at least 4 months after the last dose if treatment is discontinued.
Based on findings in animals, sotatercept may impair female and male fertility.
Sotatercept has no or negligible influence on the ability to drive and use machines.
The most frequently reported adverse reactions were headache (24.5%), epistaxis (2 2.1%), telangiectasia (16.6%), diarrhoea (15.3%), dizziness (14.7%), rash (12.3%), and thrombocytopenia (10.4%).
The most frequently reported serious adverse reactions were thrombocytopenia (<1%) and epistaxis (<1%).
The most common adverse reactions leading to discontinuation were epistaxis and telangiectasia.
The safety of sotatercept was evaluated in the pivotal study STELLAR, a placebo-controlled study of 163 patients with PAH treated with sotatercept. The median duration of treatment with sotatercept was 313 days.
The adverse reactions reported with sotatercept are listed in the table below by MedDRA system organ class and by frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), and very rare (<1/10 000).
Adverse reactions:
| System organ class | Frequency | Adverse reaction |
|---|---|---|
| Blood and lymphatic system disorders | Very common | Thrombocytopenia1,2 Increased haemoglobin1 |
| Nervous system disorders | Very common | Dizziness Headache |
| Respiratory, thoracic and mediastinal disorders | Very common | Epistaxis |
| Gastrointestinal disorders | Very common | Diarrhoea |
| Common | Gingival bleeding | |
| Skin and subcutaneous tissue disorders | Very common | Telangiectasia1 Rash |
| Common | Erythema | |
| General disorders and administration site conditions | Common | Injection site pruritus |
| Investigations | Common | Increased blood pressure1,3 |
1 See description of selected adverse reactions
2 Includes ‘thrombocytopenia’ and 'platelet count decreased'
3 Includes ‘hypertension’, ‘blood pressure diastolic increased’ and 'blood pressure increased'
In STELLAR, adverse reactions of i ncreased Hgb (‘haemoglobin increased’ and ‘polycythaemia’) were reported in 8.6% of patients taking sotatercept. Based on laboratory data, m oderate elevations in Hgb (>1.24 mmol/L (2 g/dL) above ULN) occurred in 15 .3% of patients taking sotatercept. Increases in Hgb were managed by dose adjustments.
Thrombocytopenia (‘thrombocytopenia’ and ‘platelet count decreased’) was reported in 10.4% of patients taking sotatercept. Severe reduction in platelet count <50 × 109/L occurred in 2.5% of patients taking sotatercept. Thrombocytopenia was reported more frequently in patients also receiving prostacyclin infusion (21.5%) compared to patients not receiving prostacyclin infusion (3.1%). Thrombocytopenia was managed by dose adjustments.
Telangiectasia was observed in 16.6% of patients taking sotatercept. The median time to onset was 18.6 weeks. Discontinuations of treatment due to telangiectasia were 1% in the sotatercept group.
Increased blood pressure was reported in 4.3% of patients taking sotatercept. In patients taking sotatercept, mean systolic blood pressure increased from baseline by 2.2 mmHg and diastolic blood pressure increased by 4.9 mmHg at 24 weeks.
With the exception of bleeding events (a collective group of adverse events of clinical interest), there were no differences in safety between the <65-year-old and ≥65-year-old subgroups. Bleeding events occurred more commonly in the older sotatercept subgroup (52% vs 31.9% in patients <65-year-old); however, there was no notable imbalance between age cate gories for any specific bleeding event. Serious bleeding occurred in 3.6% of patients <65-year-old and in 8.0% of patients ≥65-year-old taking sotatercept.
Long-term safety data are available from pooled phase 2 and phase 3 clinical studies (n=431). The median duration of exposure was 657 days. The safety profile was generally similar to that observed in the pivotal STELLAR study.
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