IVIG (Gamunex, Gammaguard, others)²⁶

Initial Visit:

History and Physical

• Those predisposed to acute renal failure:

  • pre-existing renal insufficiency,

  • diabetes mellitus,

  • older than 65 years,

  • volume depletion,

  • sepsis,

  • taking nephrotoxic drugs,

  • paraproteinemia

• History of thrombotic event – stroke, DVT, etc.?

• Moderate to severe heart failure

• Predisposition to thrombotic events:

  • impaired cardiac output,

  • prolonged periods of immobilization,

  • atherosclerosis,

  • multiple cardiovascular risk factors,

  • advanced age (i.e., older than 65 years),

  • coagulation disorders,

  • known or suspected hyperviscosity, including:

    • cryoglobulins,

    • fasting chylomicronemia/markedly high triglycerides,

    • monoclonal gammopathies

• History of migraine headaches (risk of aseptic meningitis)

• Live vaccine within past three months

Labs

• CBC with differential

• CMP

• Serum IgA

• Lipid profile (especially triglycerides)

• INR

• aPTT

• Cryoglobulins

• SPEP

• Hepatitis B screen: Hepatitis B sAg, Hepatitis B sAb, Hepatitis B cAb (for baseline)

• Hepatitis C ELISA screen (for baseline)

• HIV (optional)

• Pneumovax (optional)

Administration Considerations

• If administration is unavoidable:

  • Minimum infusion rate in high creatinine or thrombotic risk patients

  • Hydrate in renal insufficiency

• Epinephrine, antihistamine, acetaminophen, methylprednisolone, and crash cart at bedside as anaphylaxis or hypersensitivity precaution

• Gammunex is not compatible with saline - dilute with 5% dextrose in water

• Premedicate with acetaminophen and/or antihistamine, and/or corticosteroids (we typically delete the corticosteroid)

Counseling/Other

• Acute renal failure, especially with sucrose-containing products

• Hemolytic anemia within a few days of infusion

• Aseptic meningitis syndrome

  • Especially with high doses, rapid infusion, and history of migraine (onset in several hours up to two days after infusion)

  • Symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movement, nausea, and vomiting.

  • CSF studies are often positive for pleocytosis to several thousand granulocytic cells per cc mm and elevated protein levels to several hundred mg/dL

• Risk of thrombotic event

• Anaphylaxis and other infusion reactions

• May contain infectious agents, e.g. viruses and prions; made from large pools of human plasma

• Monitor volume and color of urine from start of first infusion to five days following last infusion

• Hyperproteinemia, increased serum viscosity, and hyponatremia (pseudohyponatremia)

• Transfusion Related Acute Lung Injury (TRALI) - non-cardiogenic pulmonary edema with severe respiratory distress 1-6 hours after infusion

  • If TRALI is suspected, test for anti-neutrophil antibodies in the patient and product serum.

• Fluid overload - especially high doses over fewer days

• May interfere with response to live viral vaccines (give vaccine more than 3 months before or 4 half-lives after)

• Non-live vaccines three months prior to first dosing if possible

• May confound results of serological testing

Follow-up Visit:

History and Physical

• Is there sustained clinical efficacy?

• Brown urine? Call doctor if urine is brown.

• Any live vaccines in past month?

• Any household members getting live vaccine?

• Other interval history

Labs

• Prior to every infusion: CMP, CBC