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IVIG Protocol

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IVIG protocol,

IVIG  INFUSION PHARMACY PROTOCOL.

Background: IVIG is a product derived from human blood and as such is subject to supply shortages
and infectious disease risks. Various formulations of IVIG also have been implicated in causing
renal dysfunction. IVIG has limited FDA-approved indications but there are many case reports and
published studies on its use for a wide variety of indications with varying results. Because IVIG is
frequently difficult to obtain, the literature has been reviewed and discussed with hematologists,
infectious disease physicians and neurologists to develop indications for IVIG where the potential
benefit from use has been well documented.

All orders for IVIG will be reviewed by the pharmacist to determine if the indication meets one of the
approved criteria defined in the attached tables. If the indication does not meet one of the criteria, the
prescriber will be notified and the IVIG will not be dispensed until further review is undertaken. The
prescribing physician will be asked to provide literature (other than a case report) supporting the use of
IVIG for the indication requested. Pharmacy, in conjunction with appropriate physician leadership, will
determine within 48 hours if the IVIG will be released for the particular patient and indication.

All doses of IVIG will be based on patient?s Ideal Body Weight (IBW) and will be rounded to the
nearest whole vial size (except neonates):
**IBW (male) = 50KG + 2.3 x (HEIGHT in INCHES > 5 Feet)

**IBW (female) = 45KG + 2.3 x (HEIGHT in INCHES > 5 Feet)

Procedure:
1. The pharmacist will review the order for IVIG and determine if the indication is approved based
on the attached tables.
2. If the indication is determined to be an approved use, the pharmacist will verify the dose is
appropriate for the indication (based on the attached table). The physician will be contacted
to clarify any doses that are not within range of the listed dose. Dose will be based on the
patient?s Ideal Body Weight. The pharmacist will dispense the dose if medication supply is
available for the entire course of therapy. The dose will be rounded to the nearest vial size
(except neonates) to avoid waste. The pharmacist will write a medication clarification order on a
physician order sheet stating the new amount of IVIG to be infused.
3. If the indication is not an approved use, the pharmacist will review the department?s IVIG file to
determine if the specific patient or indication has been previously approved and dispense as
above.
4. If the patient and/or indication have not been previously approved, the pharmacist will contact
the prescriber to inform him/her that the IVIG will not be dispensed until further review is done,
and the physician is to be asked to provide literature to support the requested indication. The
literature may not be a case study report. The decision to release the IVIG will be made within
48 hours of the physician?s request.
5. The pharmacist will copy the order for the unapproved indication and forward to the clinical
manager or pharmacy director.
6. The clinical manager or pharmacy director will review the request within 24 hours. If the
literature provided supports the requested indication, the IVIG will be released. If no supporting
literature is provided or the literature does not clearly support the indication, the clinical manager
or designee will contact the appropriate physician leadership and obtain his/her expert opinion
to determine if the product will be released within 48 hours of the original request.
7. Pharmacy will maintain an updated file of all physician-approved indications for IVIG for
reference as described in #3 above.

Table 1, Table 2, Table 3 are attached.

A. IVIG provides immediate antibody levels

B. IgG (Half-life): 21 to 29 days. Bone marrow transplant and some febrile and septic patients may have a
hypermetabolic state that can decrease the half-life to 10 to 14 days.

C. Dosing adjustment needed with renal impairment. Avoid use in CrCl less than 10 ml/min.

CONTINUE TO PREPARATION / ADMINISTRATION of IVIG:

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