- Do not give infliximab during an active infection. If an infection develops, monitor carefully and stop infliximab if the infection becomes serious.
- Invasive fungal infections—for patients who develop a systemic illness on infliximab, consider empiric anti-fungal therapy for those who reside in or travel to regions where mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis, are endemic.
- The incidence of malignancies, including lymphoma, was greater in infliximab-treated patients than in controls. Due to the risk of HSTCL, carefully assess the risks and benefits, especially in IBD patients, in men and in those receiving azathioprine or 6-mercaptopurine treatment.
- HBV reactivation can occur. Test for HBV infection before starting infliximab. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop infliximab and begin anti-viral therapy.
- Hepatotoxicity—rare severe hepatic reactions, some fatal or necessitating liver transplantation—has occurred Stop infliximab in cases of jaundice and/or marked liver enzyme elevations.
- Heart failure, new onset or worsening symptoms, may occur.
- Cytopenias—advise patients to seek immediate medical attention if signs and symptoms develop, and consider stopping infliximab.
- Hypersensitivity—serious infusion reactions, including anaphylaxis or serum sickness-like reactions, may occur.
- Demyelinating disease, exacerbation or new onset, may occur.
- Lupus-like syndrome—stop infliximab if syndrome develops.
- Live vaccines or therapeutic infectious agents should not be given with infliximab.
Dosage & Administration
Infliximab is administered by IV infusion over a period of not less than two hours. In conjunction with MTX, the recommended dose of infliximab is 3 mg/kg at Weeks 0, 2 and 6, then every eight weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
Commentary
The FDA approved infliximab for treatment of RA based on data from a clinical trial that enrolled 428 patients at 34 clinical sites. At Week 30, 50% of all patients treated with infliximab plus MTX, compared with 20% of patients receiving MTX alone, achieved an ACR20 response. The most common adverse reactions (≥10%) were infections (e.g., upper respiratory, sinusitis, pharyngitis), infusion-related reactions, headache and abdominal pain.
Tofacitinib (Xeljanz/Xeljanz XR):23 tablets
Drug class: JAK inhibitor, DMARD
Boxed warning: Refer to *ISI (p. 14) and
- Lymphoma and other malignancies have been observed in tofacitinib-treated patients. Epstein-Barr virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive medications.
- Compared with the 5 mg twice daily dose of tofacitinib or TNF blockers, the 10 mg dose has an increased risk of blood clots and death.24
Warnings & Precautions
