IVIG HCA 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.

PREPARATION / ADMINISTRATION:

A. Intravenous immune globulin products are either already in solution (recommend this formulation when possible to
avoid issues with reconstitution) or require reconstitution with provided diluent. Administration concentrations range
from 5% to 12%. If concentration is not specified on the physician order, the pharmacist will evaluate the patient's
fluid status and prepare the IVIG in an appropriate concentration. IVIG standard order sheets are available for
physicians to use when ordering IVIG.

B. Inspect Immune Globulin for particles. If particles are seen, do not shake solution as this will cause foaming, and
will inactivate the proteins in solution. The solution should be colorless, particle-free and non-turbid. If the solution
contains particles, contact pharmacy for assistance.

C. Immune Globulins should be infused separately from all other products/solutions and at room temperature. Do not
infuse Immune Globulin into other IV medication lines. Do not inject medications into the Immune Globulin infusion.
Immune Globulins should generally be infused without a filter (i.e. no blood filters, IV filter, etc.); however, some do
require an in-line filter. If filtration is required (product-specific), the filter will be provided by pharmacy.

1. Depending on the type of Immune Globulin currently stocked in the pharmacy, the product flush solution
recommendations may be either normal saline or D5W. Only flush the Immune Globulin with the flush solution
noted on the medication label and on the MAR/eMAR comment.

2. Initiate venous access with 250 ml normal saline or D5W as recommended by pharmacy and unfiltered IV
tubing using filter only if provided by pharmacy. Initiate IV Immune Globulin administration using a Secondary
Medication IV infusion set, or switch bags on the primary infusion tubing and utilize an IV infusion pump. Do not
infuse normal saline or D5W simultaneously with the Immune Globulin product.

3. Have second maintenance IV with same solution set up available in the room in case of an adverse reaction.

D. PEDIATRICS: If rate of administration is not indicated, the following rates of administration should be utilized:

1. Routine Infusion Rates for 5% - 6% IVIG:
0-15 minutes
0.5 mL/kg/hour
15-45 minutes
1 mL/kg/hour
45-75 minutes
2 mL/kg/hour
Remainder of infusion 4 mL/kg/hour

2. For 10% - 12% Concentration Divide the Infusion Rates Above (#1) by One-Half.

E. ADULTS: The following rates are independent of total dose or volume or concentration:
10ml/hr for 10 min
20 ml/hr for 20 min
50 ml/hr for 20 min
100 ml/hr for 1 hour
200 ml/hr until the infusion is completed

F. ADULTS—OUTPATIENT INFUSION CENTER

1. FOR INITIAL IVIG TREATMENT (new brand, changing renal function or experiencing new side effects): follow
the adult titration rate schedule as above.

2. FOR SUBSEQUENT / REPEAT IVIG treatment: titration of the dose is not necessary if the patient receives the
same IVIG brand as on previous visit, the infusion rate has stayed constant as on previous visit (with no side
effects), and the patient's renal function has not decreased significantly since the previous visit.

G. MONITORING REQUIREMENTS:

Obtain and document vital signs every 30 minutes for 2 hours, then every 2 hours until infusion is completed
or as ordered by the physician. All patients should have continuous electronic monitoring of heart rate,
respiratory rate, and oxygen saturation throughout the infusion.

2. Adults: All patients have vital signs taken pre-IVIG, then roughly halfway through the infusion and again upon
completion of infusion.

H. ADVERSE REACTIONS / CONTRAINDICATIONS / WARNINGS PRECAUTIONS:

1. Observe and assess for adverse drug effects / reactions when collecting and documenting vital sign information.

2. Based on the adverse drug effects / reactions observed:

Notify physician immediately.
If necessary discontinue the IVIG.
o Adult and Pediatric Units: Begin infusion of normal saline or D5W as indicated by pharmacy at a
keep open rate or flush with 10 to 20 mL of the appropriate solution as above.
o NICU / Nursery: heparin lock the IV cannula.
Report any observed Adverse Drug Reactions to the ADR Hotline.

3. Adverse drug effects / reactions include the following:

• Cardiovascular System: Flushing of the face, hypotension, tachycardia
• Central Nervous System: Dizziness, fever, headache, chills
• Gastrointestinal: Nausea
• Respiratory: Chest tightness, difficulty breathing
• Miscellaneous: Hypersensitivity reactions, sweating
4. CONTRAINDICATIONS:

Selective IgA deficiency (except with Polygam)

History of anaphylactic episode following previous IVIG infusion

Severe thrombocytopenia or other contraindication to IM or IV injections

5. WARNINGS / PRECAUTIONS: Anaphylactic type reactions may occur and proper monitoring for these reactions

concomitant nephrotoxic drugs

human plasma products may contain infectious agents

pre-existing renal insufficiency

cardiovascular risk factors- Patients receiving large volumes of fluid due to 5% IVIG concentration and
large dosage requirements should be observed for signs of fluid overload. Infusion rate should be
decreased if necessary.

decreased cardiac output

sucrose-containing products increase risk of renal dysfunction

increased risk of inflammatory reactions in patients with agammaglobulinemia or extreme
hypogammaglobulinemia receiving first doses or after 8 weeks

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