Dose

As there are significant differences in the half-life of IgG among patients with primary humoral immunodeficiencies, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.

The dose of Octagam 5% liquid for replacement therapy in primary humoral immunodeficiency diseases is 300 to 600 mg/kg body weight (6-12 mL/kg) administered every 3 to 4 weeks. Adjust the dosage over time to achieve the desired trough levels and clinical responses. If a patient on regular treatment missed a dose, administer the missed dose as soon as possible, and then continue treatment as before.

Measles Exposure

If a patient with primary humoral immunodeficiency has been exposed to measles, it may be prudent to administer an extra dose of IGIV as soon as possible and within 6 days of exposure. A dose of 400 mg/kg should provide a serum level > 240 mIU/mL of measles antibodies for at least two weeks.

If a patient with primary humoral immunodeficiency is at risk of future measles exposure and receives a dose of less than 530 mg/kg every 3-4 weeks, the dose should be increased to at least 530 mg/kg. This should provide a serum level of 240 mIU/mL of measles antibodies for at least 22 days after infusion.

Preparation

• Inspect each vial of Octagam 5% liquid visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid and/or a discoloration is observed.
• Do not freeze. Do not use solutions that have been frozen.
• Octagam 5% liquid contains no preservative. The Octagam 5% liquid bottle is for single use only. Promptly use any bottle that has been entered.
• Prior to use, allow the solution to reach ambient room temperature.
• Do not use after expiration date.
• The content of Octagam 5% liquid bottles may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling.
• Do not dilute Octagam 5% liquid. Do not mix Octagam 5% liquid with other medicinal products.
• Do not mix with immune globulin intravenous (IGIV) products from other manufacturers.

Administration

Octagam 5% liquid is for intravenous use only.

• The infusion line may be flushed before and after administration of Octagam 5% liquid with either normal saline or 5% dextrose in water.
• Administer Octagam 5% liquid at room temperature.
• Do not administer Octagam 5% liquid simultaneously with other intravenous preparations in the same infusion set.
• Octagam 5% liquid is not supplied with an infusion set. If using an in-line filter, choose a filter with a pore size of 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 within the ring and perpendicularly to the plane of the stopper.
• 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 [subside or] 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 5% at the minimum infusion rate practicable, not to exceed 3.3mg/kg/min (0.07 mL/kg/min). Discontinue Octagam 5% if renal function deteriorates.

Rate of Administration

Initially infuse Octagam 5% liquid at infusion rates stated below, at least until the physician has had adequate experience with a given patient.

Infusion rates (see also Table 1): 0.5 mg/kg/min (30 mg/kg/hr) for the first 30 minutes; if tolerated, advance to 1 mg/kg/min (60 mg/kg/hr) for the second 30 minutes; and if still tolerated, advance to 2 mg/kg/min (120 mg/kg/hr) for the third 30 minutes. If tolerated the infusion rate can be increased to and maintained at a maximum rate of 3.33 mg/kg/min (200 mg/kg/hr)

For patients judged to be at risk for developing renal dysfunction, administer Octagam 5% liquid at the minimum infusion rate practicable, not to exceed 0.07 mL/kg (3.3 mg/kg)/min (200 mg/kg/hr).

Table 1: Infusion Rates

• Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.
• Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Octagam 5% liquid if renal function deteriorates.
• For patients at risk of renal dysfunction or thromboembolic events, administer Octagam 5% liquid at the minimum infusion rate practicable.