Certolizumab pegol (Cimzia):18 Injection
Drug class: TNF inhibitor
Boxed warning: Refer to *ISI (p. 17)
Warnings & Precautions
- Do not start certolizumab during an active infection. If an infection develops, monitor carefully, and stop certolizumab if the infection becomes serious.
- Invasive fungal infections may occur. For patients who develop a systemic illness on certolizumab, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic.
- Cases of lymphoma and other malignancies have been observed in patients receiving TNFi’s.
- Heart failure, worsening or new onset, may occur.
- Anaphylaxis or serious allergic reactions may occur.
- HBV reactivation can occur. Test for HBV infection before starting certolizumab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop certolizumab and begin anti-viral therapy.
- Demyelinating disease, exacerbation or new onset, may occur.
- Cytopenias and pancytopenia may develop. Advise patients to seek immediate medical attention if symptoms develop, and consider stopping certolizumab.
- Lupus-like syndrome—stop certolizumab if the syndrome develops.
Commentary: The FDA approval was based on a multi-center, clinical trial, which showed that patients treated with 200 mg certolizumab every other week demonstrated greater reduction in radiographic progression compared with placebo-treated patients at Week 24.The most common adverse reactions (≥7%) are upper respiratory tract infection, rash and urinary tract infection.
Golimumab (Simponi):19 Injection
Drug class: TNF inhibitor
Boxed warning: Refer to *ISI (p. 17)
Warnings & Precautions
- Do not start golimumab during an active infection. If an infection develops, monitor carefully, and stop golimumab if the infection becomes serious.
- For patients who develop a systemic illness on golimumab, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic.
- HBV many occur. Monitor HBV carriers during and for several months after therapy. If reactivation occurs, stop golimumab and begin anti-viral therapy.
- The incidence of lymphoma was seen more often than in the general U.S. population. Cases of other malignancies have been observed among patients receiving TNFi.
- Heart failure, worsening or new onset, may occur. Stop golimumab if new or worsening symptoms occur.
- Demyelinating disease, exacerbation or new onset, may occur.
- Serious systemic hypersensitivity reactions, including anaphylaxis, may occur.
Commentary: The FDA approval of golimumab is based on results from a clinical trial that demonstrated a higher proportion of patients having significant improvement in the signs and symptoms of PsA. The most common adverse reactions (≥5%) are upper respiratory tract infection and nasopharyngitis.