For intravenous use only.
2.1 Dosage
Administer Octagam 10% at a total dose of 2 g/kg, divided into two doses of 1 g/kg (10mL/kg) given on two consecutive days.
2.2 Preparation and handling
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if Octagam 10% is turbid and/or if discoloration is observed.
Do not mix Octagam 10% with other medicinal products or administer simultaneously with other intravenous preparation in the same infusion set. Do not mix Octagam 10% with immune globulin intravenous (IGIV) products from other manufacturers.
Do not freeze Octagam 10%. Do not use solutions that have been frozen.
Octagam 10% contains no preservative. Octagam 10% bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles.
The content of Octagam 10% bottles may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling.
Do not use after expiration date.
Do not dilute Octagam 10%.
The infusion line may be flushed before and after administration of Octagam 10% with either normal saline or 5% dextrose in water.
2.3 Administration
Administer Octagam 10%, which is to be at room temperature, only by the intravenous route.
Octagam 10% is not supplied with an infusion set. If an in-line filter is used the pore size should be 0.2 – 200 microns.
Do not use a needle of larger than 16 gauge to prevent the possibility of coring. Insert needle only once, within the stopper area delineated (by the raised ring for penetration). Penetrate the stopper perpendicular to its plane and within the ring.
For rate of administration, see Table 1.
Table 1
Rate of Administration
mg/kg/min (mg/kg/hour)
mL/kg/min
first 30 min
1 (60)
0.01
next 30 min, if above is tolerated
2 (120)
0.02
next 30 min, if above is tolerated
4 (240)
0.04
next 30 min, if above is tolerated
8 (480)
0.08
Maximum
≤ 12 (≤720)
≤0.12
Monitor the patient carefully throughout the infusion. Certain adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly. Once the symptoms subside, the infusion may then be resumed at a lower rate.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thromboembolic events, administer Octagam 10% at the minimum infusion rate practicable, not to exceed 3.3 mg/kg/min (0.03 mL/kg/min). Discontinue Octagam 10% if renal function deteriorates.