Examining
IVIG-Related TEEs

A closer look at the risk of
thromboembolic events (TEEs)

Identifying TEEs

The main mechanisms of IVIG-associated TEEs include:

Increased concentrations of pro-coagulant clotting factors, especially FXIa¹²
Increased blood viscosity¹²
Anti-cardiolipin antibodies¹²
Platelet and monocyte activation¹²
Autoimmune vasculitis¹³

Other physiological changes that occur following IVIG administration could also theoretically increase the risk for a TEE, including:

Vasospasm¹³
Release of vasoactive cytokines⁵
Rapid intravascular compartment expansion⁵
Reduced capillary blood flow caused by alterations in venous compliance⁵

Underlying patient risk factors elevate the risk of TEEs

The FDA emphasizes the need to consider patient characteristics in the administration of IVIG following an investigation that showed that most patients experiencing TEEs had pro-thrombotic comorbidities.²

Comorbidities that elevate a patient’s risk for a TEE include:

Advanced age¹²

Diabetes mellitus¹²

Obesity¹²

Familial or personal history of vascular disease, thrombosis, or acquired/inherited thrombotic disorders¹²

Hypertension¹²

Immobility¹²

Hyperlipidemia¹²

Renal disease¹⁴

Anti-phospholipid syndrome¹²

Clotting disorder¹⁴

Other factors that may increase a patient’s risk for TEEs include a first infusion consisting of a large dose of immunoglobulin, use of oral contraceptives, elevated serum viscosity, immune thrombocytopenia (ITP), and viral infection.^13,15

The presence of four or more risk factors seems to be significantly associated with the onset of immunoglobulin-related thrombotic events.¹³

It is important to tailor IVIG product selection to patient risk factors

Each manufacturer’s plasma collection and manufacturing methods are unique and influence the biochemical characteristics and tolerability of the final immunoglobulin product.² Matching the right IVIG product with the right patient requires careful consideration.

The following should be carefully considered and evaluated:

Product characteristics^11,16:

Sugar content
Stabilizer
Concentration
Osmolality
Sodium content
Immunoglobulin A (IgA) content
Volume
pH

Patient characteristics^11,16:

Contraindications
Age
Renal insufficiency
Cardiac insufficiency
Pulmonary insufficiency
Diabetes
History of myocardial infarction
Deep vein thrombosis
Pulmonary embolism
Thrombotic disorder

Examining IVIG-Related TEEs