Dosage & Administration for Adult Dermatomyositis

Octagam 10% is for Intravenous Use Only.

Recommended Dose and Infusion Rate
DoseInitial infusion rateMaintenance infusion rate
(if tolerated)
2 g/kg
Divided in equal doses given over 2 to 5 consecutive days every 4 weeks
1.0 mg/kg/min
(0.01 ml/kg/min)
Up to 4.0 mg/kg/min
(up to 0.4 ml/kg/min)

Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue octagam 10% if renal function deteriorates. For patients at risk of renal dysfunction or thrombotic events, administer octagam 10% at the minimum infusion rate practicable, not to exceed 3.3 mg/kg/min (0.03 mL/kg/min).

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 IVIg 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

Administration

Administer octagam 10% 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

Octagam 10%: Rate of Administration in DM

Rate of administrationmg/kg/min (mg/kg/hour)mL/kg/min
First 30 min1 (60)0.01
Next 30 min2 (120)0.02
Next 30 min4 (240)0.04*

*Patients with DM are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 ml/kg/min.

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.

Please see full prescribing information for complete information on dosing and administration

Review information and recommendations about octagam 10% supply and storage requirements.