Table 3 Biologicals warnings—consult summary of product characteristics.
| Biological agent | Molecular target | Specific warnings |
|---|---|---|
| Adalimumab | TNFα | Risk of infection, especially TB |
| Patients should be assessed for active/latent TB before treatment. Treatment of latent TB should be initiated before treatment with adalimumab, contraindicated in active TB | ||
| Etanercept | TNFα | Infection |
| Infliximab | TNFα | Risk of infection, especially TB. |
| Patients should be assessed for active/latent TB and treatment should be initiated before treatment with infliximab, contraindicated in active TB | ||
| Invasive fungal and other opportunist infections. | ||
| Hypersensitivity reactions | ||
| Rituximab | CD20 | Infusion reactions |
| Tumour lysis syndrome | ||
| Severe mucocutaneous reactions | ||
| Ibritumomab tiuxetan | CD20 | Fatal infusion reactions |
| Prolonged and severe cytopenias | ||
| Tositumomab and 131I tositumomab | CD20 | Hypersensitivity reactions |
| Prolonged and severe cytopenias | ||
| Basiliximab | CD25 | Only administered by doctors experienced in immunosuppressive treatment and management of organ transplantation. Facilities must be equipped and staffed with adequate laboratory and supportive medical resources |
| Daclizumab | CD25 | Only administered by doctors experienced in immunosuppressive treatment and management of organ transplantation. Facilities must be equipped and staffed with adequate laboratory and supportive medical resources |
| Alemtuzumab | CD52 | Haematological toxicity (ITP alert, November 2005) |
| Infusion reactions | ||
| Infection/opportunist infection | ||
| Cetuximab | EGFR | Infusion reactions |
| Bevacizumab | VEGF | Gastrointestinal perforation |
| Wound‐healing complications | ||
| Haemorrhage | ||
| Trastuzumab | HER2 | Cardiomyopathy especially when given with anthracyclines and cyclophosphamide |
| Palivizumab | RSV F protein | Anaphylaxis (rare) |
CD, cluster of differentiation; EGFR, epidermal growth factor receptor; HER2, human epidermal growth factor receptor 2; RSV, respiratory syncitial virus; TB, tuberculosis; TNF, tumour necrosis factor; VEGF, vascular endothelial growth factor.