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UP Health System - Marquette
Pharmacy and Therapeutics Committee
Medication Guideline
Drug Classification: 80:04.00 Serums
Agent:
Intravenous immune globulin (Octagam® 5%
liquid)
Intravenous immune globulin
(Octagam® 10% liquid)
All other IVIG formulations
Formulary
Nonformulary
Restricted
X
X
X
X
Nonstock
X
X
X
Pharmacy and Therapeutics Committee-approved Indications for Inpatient Use:
Intravenous immune globulin (IVIG) is approved for use according to both the evidence and the strength of
the literature. Outpatient administration of IVIG is encouraged unless the patient’s condition necessitates
inpatient administration.
IVIG liquid 5% (Octagam®) is the IVIG formulation available on the Formulary. If a patient is unable to
receive the 5% solution, the 10% solution may be procured on a patient-specific basis.
Dosage & Administration:
Primary Immunodeficiency
Diseases:
200 to 800 mg/kg IV once every 3 to 4 weeks; individualize dose based on clinical response or
target trough serum IgG levels
Idiopathic Thrombocytopenia
Purpura:
Neurological Indications:
1,000 mg/kg IV daily for 2 consecutive days (total dose of 2 gm/kg)
Transplant Indications (renal
allograft):
Acute antibody mediated rejection (AMR), type I, II, or III with documented donor specific antibody
(DSA):
day 1-180: 100 mg/kg IV every other day for 3-5 days
day >180: 2,000 mg/kg IV over 48 hours, repeat at 30 days
Total dose per course is 2 gm/kg which may be divided out in the following manner:
400 mg/kg IV daily for 5 days or
500 mg/kg IV daily for 4 days or
1,000 mg/kg IV daily for 2 days
Mixed acute AMR with documented DSA:
day 1-180: 1,000-2,000 mg/kg IV
day >180: 1,000-2,000 mg/kg IV
Chronic active AMR with or without DSA:
1,000-2,000 mg/kg IV over 48 hours
Recommended Infusion
Rate:
Desensitization:
single DSA positive and median fluorescence intensity (MFI) between 500 and 1500 (weak
positive): 2,000 mg/kg IV prior to transplantation
single DSA positive and MFI >1500 (strongly positive): 2,000 mg/kg IV prior to transplantation
Adults:
IVIG for infusion is to be started at 0.5 ml/kg/hr and titrated every 30 minutes if tolerated to a
maximum rate of 5 ml/kg/hr (Maximum rate < 2 ml/kg/hr in patients at high-risk for renal impairment
or thrombotic events). Vital signs need to be monitored at baseline, after the first 15 minutes of the
infusion, every 30 minutes thereafter, and at the completion of the infusion to ensure the patient
tolerates the infusion rate. (Nursing Procedure B-005A)
Note: IVIG doses should be rounded to the nearest 5 gram increment in adult patients. IVIG should be dosed using
adjusted body weight (ABW) to allow for distribution into extra body fluids for patients with a body mass index ≥ 30
2
kg/m or if the patient’s actual body weight is more than 20% over Ideal body weight (IBW) using the following
formula: ABW = IBW + 0.5 (actual body weight – IBW).
Document created: 01/12.
Revised: 11/14, 01/13.
Cross Reference: Nursing Procedure B-005A.
Marquette General Health System
Marquette General Hospital
Marquette, MI 49855
This is a confidential professional/peer review and quality assessment document of Marquette General Health System of Marquette, MI. It is
protected from disclosure pursuant to the provisions of MCL 333.20175, MCL 333.21513, MCL 21515, MCL 331.531, MCL 331.533, MCL 330.1143a,
and other state and federal laws. Unauthorized disclosure or duplication is absolutely prohibited.
UP Health System - Marquette
Pharmacy and Therapeutics Committee
Medication Guideline
Monitoring / Outcomes:
Infusion Reactions: Monitor for the following symptoms: flushing of the face, chest tightness, chills, fever,
dizziness, nausea, vomiting, diaphoresis, and hypotension. If these reactions occur, stop the infusion
temporarily until the symptoms have subsided. Anaphylaxis may occur and these reactions generally
occur 30 minutes to 1 hour after initiation on infusion.
Renal function: Monitor BUN, serum creatinine, and urine output prior to the initial infusion and periodically
thereafter. Also, monitor for sudden weight gain, fluid retention/edema, and/or shortness of breath.
FDA Warnings:
Thrombotic events: Patients at risk may include those with a history of atherosclerosis, multiple
cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected
hyperviscosity. Rapid infusion rates and high doses of IVIG might be additional risk factors in patients
who are already at risk for thrombotic events. The potential risks and benefits of IVIG should be
weighed against those of alternative therapies for all patients for whom IVIG administration is being
considered. Baseline assessment of blood viscosity should be considered in patients at risk for
hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides,
or monoclonal gammopathies.
Nephrotoxicity: Safety precautions should be taken to reduce the potential risk of ACUTE RENAL
FAILURE (ARF) reported to be associated with the administration of Immune Globulin Intravenous
(Human) (IGIV) products. Preliminary evidence suggests that IVIG products containing sucrose may
present a greater risk for this complication. Hyperosmolality of certain reconstituted products, as well as
differences in stabilizer sugar choice and content between IVIG, may be among the factors that have
contributed to different reported rates of renal dysfunction for the various IVIG products. If a sucrosecontaining IVIG product is used in patients at risk, the maximum infusion rate should not exceed 3 mg
sucrose/kg/min. Octagam® does not contain sucrose.
IgA deficiency: IVIG preparations with trace amounts of IgA are not indicated in patients with selective
IgA deficiency where the IgA deficiency is the only abnormality of concern. It should be given with
caution to patients with antibodies to IgA or IgA deficiencies that are a component of an underlying
primary immunodeficiency disease for which IGIV therapy is indicated. In such instances, a risk of
anaphylaxis may exist despite the fact that these IVIG preparations contain only trace amounts of IgA.
Octagam® contains trace amounts of IgA. If a patient has documented IgA deficiency and requires lowIgA IVIG therapy as an inpatient, contact the Pharmacy Department for more information (225-3495).
Transfusion-related Acute Lung Injury (TRALI): There have been reports of noncardiogenic pulmonary
edema in patients administered IGIV. TRALI is characterized by severe respiratory distress, pulmonary
edema, hypoxemia, normal left ventricular function, and fever and typically occurs within 1 to 6 hours
following transfusion. IGIV recipients should be monitored for pulmonary adverse reactions. Patients
with TRALI may be managed using oxygen therapy with adequate ventilatory support. If TRALI is
suspected, appropriate tests should be performed for the presence of antineutrophil antibodies in both
the product and the patient’s serum.
Special Handling Procedures:
IVIG is not considered a hazardous drug.
IVIG is not considered a high-alert drug.
Document created: 01/12.
Revised: 11/14, 01/13.
Cross Reference: Nursing Procedure B-005A.
Marquette General Health System
Marquette General Hospital
Marquette, MI 49855
This is a confidential professional/peer review and quality assessment document of Marquette General Health System of Marquette, MI. It is
protected from disclosure pursuant to the provisions of MCL 333.20175, MCL 333.21513, MCL 21515, MCL 331.531, MCL 331.533, MCL 330.1143a,
and other state and federal laws. Unauthorized disclosure or duplication is absolutely prohibited.