Dosage & Administration
For intravenous use only.
| Indication | Dose | Initial Infusion rate | Maintenance Infusion Rate (if tolerated) |
| Chronic ITP | 2 g/kg divided in equal doses given over 2 consecutive days | 1.0 mg/kg/min(0.01 mL/kg/min) | Up to 12.0 mg/kg/min(Up to 0.12 mL/kg/min) |
| Dermato-myositis | 2 g/kg divided in equal doses given over 2-5 consecutive days every 4 weeks | 1.0 mg/kg/min(0.01 mL/kg/min) | Up to 4.0 mg/kg/min(Up to 0.04 mL/kg/min) |
•Patients with dermatomyositis are at increased risk for thromboembolic Events; monitor carefully and do not exceed an infusion rate of 0.04 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 .
Octagam 10% Prescribing Information
THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. (See WARNING and PRECAUTIONS [ 5.5], PATIENT COUNSELING INFORMATION [ 17]
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including Octagam 10%. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV product containing sucrose. Octagam 10% does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Octagam 10% at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. (See DOSAGE and ADMINISTRATION [ 2.3], WARNINGS and PRECAUTIONS [ 5.5])
Chronic Immune Thrombocytopenic Purpura (ITP)
Octagam 10% is indicated for the treatment of chronic immune thrombocytopenic purpura to rapidly raise platelet counts to control or prevent bleeding in adults.
Dermatomyositis (DM)
Octagam 10% is indicated for the treatment of dermatomyositis in adults.
For intravenous use only.
Dosage
| Indication | Dose | Initial Infusion rate | Maintenance Infusion Rate (if tolerated) |
| Chronic ITP | 2 g/kg divided in equal doses given on 2 consecutive days | 1.0 mg/kg/min(0.01 mL/kg/min) | Up to 12.0 mg/kg/min(Up to 0.12 mL/kg/min) |
| Dermatomyositis (DM) | 2 g/kg divided in equal doses given over 2-5 consecutive days every 4 weeks | 1.0 mg/kg/min(0.01 mL/kg/min) | Up to 4.0 mg/kg/min(Up to 0.04 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 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.
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 |
*Patients with dermatomyositis 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.
Solution containing 10% IgG (100 mg/mL) (See How Supplied/Storage and Handling ).
Pregnancy
Risk Summary
No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with Octagam 10%. It is not known whether Octagam 10% can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Octagam 10% should be given to pregnant women only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Lactation
Risk Summary
No human data are available to assess the presence or absence of Octagam 10% in human milk, the effects of Octagam 10% on the breastfed child, and the effects of Octagam 10% on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Octagam 10% liquid and any potential adverse effects on the breastfed infant from Octagam 10% liquid or from the underlying maternal condition. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.
Pediatric Use
The safety and effectiveness of Octagam 10% has not been established in pediatric patients with ITP or DM.
Geriatric Use
Patients > 65 years of age may be at increased risk for developing certain adverse reactions such as thromboembolic events and acute renal failure (See Boxed Warnings and Thrombotic Events and Renal Failure . Do not exceed recommended doses in this population, and the applied infusion rate should be the minimum practicable. Clinical studies of Octagam 10% did not include sufficient numbers of subjects > 65 years to determine whether they respond differently from younger subjects. During the First Period (placebo-controlled) of the DM trial, 11 patients over 65 years were treated with Octagam.
- Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin.
- Octagam 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.