13
Contraindications and Cautions
IVIG is contraindicated in those with a history of anaphylactic or severe systemic
reaction to human immune globulin, hyperprolinemia or IgA-deficient patients with
antibodies to IgA and a history of hypersensitivity.
Warning for IVIG use that thrombosis and renal dysfunction in predisposed patients
can occur. For patients at risk of thrombosis, renal dysfunction, or failure, administer
IVIG at the minimum dose and infusion rate practicable. Ensure adequate hydration
in patients before administration. Monitor for signs and symptoms of thrombosis and
assess blood viscosity in patients at risk for hyperviscosity.
Contraindicated in pregnant women, or women of childbearing potential who are not
using reliable contraception, patients with pre-existing acute or chronic liver disease,
or those with serum ALT >2× ULN before initiating treatment, patients with known
hypersensitivity to leflunomide or any of the other components of leflunomide and
patients being treated with teriflunomide.
Severe liver injury, including fatal liver failure, has been reported in some patients
treated with leflunomide. Leflunomide is not recommended for patients with severe
immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections.
Contraindicated in pregnancy, alcoholism or liver disease, immunodeficiency
syndromes, preexisting blood dyscrasias, hypersensitivity to methotrexate.
Warnings for methotrexate include potential for organ system toxicity, may cause
impairment of fertility, oligospermia and menstrual dysfunction, elimination is reduced
in patients with impaired renal function, ascites, or pleural effusions, may cause dizziness
and fatigue, may impair ability to drive or operate machinery
MMF is contraindicated in patients with hypersensitivity to mycophenolate mofetil,
MPA acid, or any component of the drug product and in patients allergic to Polysorbate
80.
Warning that use during pregnancy is associated with increased risks of first trimester
pregnancy loss and congenital malformations. Females of reproductive potential must
be counseled regarding pregnancy prevention and planning. ere is an increased risk
of the development of lymphoma and other malignancies, particularly of the skin. ere
is also an increased susceptibility to infections, including opportunistic infections and
severe infections with fatal outcomes.
Contraindications include hemodynamic instability or septicemia, known allerg y to
fresh frozen plasma or replacement colloid/albumin, known allerg y to heparin.
Warning that complications may occur, including hypocalcemia or hypomagnesemia,
hypothermia, transfusion reactions, fluid and electrolyte imbalance, bleeding diatheses,
hypotension, flushing, and GI symptoms like nausea and vomiting.
