9
Contraindications and Cautions
Infliximab at doses >5 mg/kg is contraindicated in moderate to severe heart failure.
It is also contraindicated in patients with previous severe hypersensitivity reaction to
infliximab or known hypersensitivity to inactive components of infliximab or to any
murine proteins.
Warning with infliximab include increased risk of serious infections leading to
hospitalization or death. Discontinue infliximab if a patient develops a serious infection.
Perform test for latent tuberculosis (TB); if positive, start treatment for TB prior to
starting infliximab. Monitor all patients for active TB during treatment, even if initial
latent TB test is negative. Cases of fatal hepatosplenic T-cell lymphoma (HSTCL)
have been reported in patients treated with TNF blockers including infliximab. All
infliximab cases were reported in patients with Crohn's disease or ulcerative colitis, the
majority of whom were adolescent or young adult males. All had received azathioprine
or 6-mercaptopurine concomitantly with infliximab at or prior to diagnosis.
No contraindications.
Warnings for rituximab include fatal infusion reactions within 24 hours of rituximab
infusion have been reported. Approximately 80% of fatal reactions occurred with
the first infusion. Monitor patients and discontinue RITUXAN infusion for severe
reactions. Tumor lysis syndrome, severe mucocutaneous reactions, some with fatal
outcomes, and PML resulting in death have also been reported.
Tocilizumab is contraindicated in patients with known hypersensitivity to tocilizumab.
Warning that use of tocilizumab can result in serious infections leading to
hospitalization or death including TB, bacterial, invasive fungal, viral, and other
opportunistic infections have occurred in patients receiving tocilizumab. If a serious
infection develops, interrupt tocilizumab until the infection is controlled. Perform test
for latent TB; if positive, start treatment for TB prior to starting tocilizumab. Monitor
all patients for active TB during treatment, even if initial latent TB test is negative.
Vedolizumab is contraindicated in patients who have had a known serious or severe
hypersensitivity reaction to vedolizumab or any of its excipients.
Warnings for vedolizumab include hypersensitivity reactions (including anaphylaxis),
infections – treatment with vedolizumab is not recommended in patients with active,
severe infections until the infections are controlled. Although no cases of Progressive
Multifocal Leukoencephalopathy have been observed in clinical trials, JCV infection
resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred
in patients treated with another integrin receptor antagonist. A risk of PML cannot be
ruled out. Monitor patients for any new or worsening neurologic signs or symptoms.
Ustekinumab is contraindicated in patients who have a significant hypersensitivity to
ustekinumab or any of its excipients.
Warnings for ustekinumab include risk of infection, malignancies, and hypersensitivity
reactions.
