7
Contraindications and Cautions
Anakinra is contraindicated in patients known hypersensitivity to E coli-derived
proteins, anakinra, or to any component of the product.
Warning that use in combination with Tumor Necrosis Factor (TNF) blocking agents
is not recommended. Hypersensitivity reactions, including anaphylactic reactions and
angioedema, have been reported. e impact of treatment with anakinra on active and/
or chronic infections and the development of malignancies is not known. Live vaccines
should not be given concurrently with anakinra. Neutrophil counts should be assessed
prior to initiating anakinra treatment and while receiving anakinra, monthly for 3
months, and thereaer quarterly for a period up to 1 year.
Contraindicated in patients with hypersensitivity to rabbit/horse proteins or to any
product excipients or active acute or chronic infections, which would contraindicate any
additional immunosuppression.
Medical surveillance is required during thymoglobulin infusions. Serious immune-
mediated reactions have been reported with the use of thymoglobulin and consist of
anaphylaxis or severe CRS.
Contraindicated in patients with a previous severe hypersensitivity reaction to
caplacizumabyhdp or to any of the excipients. Hypersensitivity reactions have included
urticaria.
Caplacizumab increases the risk of bleeding. In clinical studies, severe bleeding adverse
reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and
metrorrhagia were each reported in 1% of subjects.
Dupilumab is contraindicated in patients with known hypersensitivity to dupilumab or
any of its excipients.
Warning that hypersensitivity reactions, (including anaphylaxis), conjunctivitis and
eosinophilic conditions have occurred in patients treated with dupilumab.
Warning to not discontinue systemic, topical, or inhaled corticosteroids abruptly upon
initiation of therapy with dupilumab. Also, treat patients with pre-existing helminth
infections before initiating therapy with dupilumab.
Eculizumab is contraindicated in patients with unresolved serious Neisseria meningitidis
infection and patients who are not currently vaccinated against Neisseria meningitidis,
unless the risks of delaying eculizumab treatment outweigh the risks of developing a
meningococcal infection.
Warning that life-threatening and fatal meningococcal infections have occurred in
patients treated with eculizumab. Discontinue eculizumab in patients who are being
treated for serious meningococcal infections and use caution when administering to
patients with any other systemic infection.
