Octagam Immune Globulin
Loading...Octagam Immune Globulin Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.
History
There is currently no drug history available for this drug.
Other Information
Immune Globulin Intravenous (Human), Octagam 5% liquid, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 5% liquid is a solution for infusion which must be administered intravenously.
All units of human plasma used in the manufacture of Octagam 5% liquid are provided by FDA-approved blood establishments only, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative).
The product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Triton X-100 (Octoxynol). The Octagam 5% liquid manufacturing process provides a significant viral reduction in in vitro studies (table 7). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment.
Table 7: In vitro reduction factor during Octagam 5% liquid manufacturing
WNV: West Nile Virus
HIV-1: Human Immunodeficiency Virus - 1
PRV: Pseudorabies Virus
SBV: Sindbis Virus
MEV: Mouse Encephalomyelitis Virus
PPV: Porcine Parvovirus
The composition of Octagam 5% liquid is shown in table 8 as follows:
Table 8 : Composition
| Component | Quantity/ml |
|---|---|
| Protein, of which not less than 96% is human normal immunoglobulin G |
50 mg |
| Maltose |
100 mg |
| Triton X-100 |
not more than 5 mcg |
| TNBP |
not more than 1 mcg |
| IgA |
not more than 0.2 mg |
| IgM |
not more than 0.1 mg |
| Water for Injection |
ad. |
This preparation contains approximately 50 mg of protein per ml (5%) of which not less than 96% is human normal immunoglobulin G. Octagam 5% liquid contains not more than 3% aggregates, not less than 90% monomers and dimers and not more than 3% fragments.
The sodium content of the final solution is not more than 30 mmol/l and the pH is between 5.1 and 6.0. The osmolality is 310 - 380 mosmol/kg.
The manufacturing process for Octagam 5% liquid isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact Octagam 5% liquid contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG 1 is 65%, IgG 2 is 30%, IgG 3 is 3% and IgG 4 is 2%.
Octagam 5% liquid contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins.
Octagam 5% liquid contains no preservative and no sucrose.
Sources
Octagam Immune Globulin Manufacturers
-
Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
![Octagam Immune Globulin (Human) (Immune Globulin) Solution [Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Octagam Immune Globulin | Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
For intravenously use only
Preparation and handling Octagam 5% liquid should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or discoloration is observed. Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparation in the same infusion set. Do not mix with immune globulin intravenous (IGIV) products from other manufacturers. Do not freeze. Solutions that have been frozen should not be used. Octagam 5% liquid bottle is for single use only. Octagam 5% liquid contains no preservative. Any bottle that has been entered should be used promptly. Partially used bottles should be discarded. 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 use after expiration date. Octagam 5% liquid should not be diluted. Treatment of Primary Humoral ImmunodeficiencyAs 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 (6-12ml/kg) administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical responses.
If a patient is at risk of measles exposure (ie., outbreak in US or travel to endemic areas outside of the US) and receives a dose of less than 400 mg/kg every 3 to 4 weeks, the dose should be increased to at least 400 mg/kg. If a patient has been exposed to measles, this dose should be administered as soon as possible after exposure.
Missed DosesIf a patient on regular treatment missed a dose, the missed dose should be administered as soon as possible, and then treatment should continue as before.
AdministrationOctagam 5% liquid should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or discoloration is observed.
Octagam 5% liquid should be at room temperature during administration. Only administer intravenously.
Any bottle that has been opened should be used promptly. Partially used bottles should be discarded.
Octagam 5% liquid 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). The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Rate of Administration
It is recommended that Octagam 5% liquid be initially infused at infusion rates stated below, at least until the physician has had adequate experience with a given patient.
Infusion rates: 0.5mg/kg/min (30mg/kg/hr for the first 30 minutes; if tolerated, advance to 1mg/kg/min (60mg/kg/hr) for the second 30 minutes; and if further tolerated, advance to 2mg/kg/min (120mg/kg/hr) for the third 30 minutes. Thereafter the infusion can be maintained at a rate up to, but not exceeding, 3.33mg/kg/min (200mg/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)/minute (200 mg/kg/hour).
Table 1
Rate of Administration mg/kg/min (mg/kg/hour) ml/kg/minfirst 30 min
0.5 (30)
0.01
next 30 min
1.0 (60)
0.02
next 30 min
2.0 (120)
0.04
Maximum
< 3.33 (<200)
<0.07
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.
Incompatibilities
Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparations in the same infusion set.
Shelf-life
Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.
Special Precautions for Storage
Do not freeze. Frozen product should not be used.
Do not use after expiration date.
-
Octapharma Ab
Octagam Immune Globulin | Octapharma Ab
For intravenously use only
2.1 Preparation and handling Octagam 5% liquid should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or discoloration is observed. Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparation in the same infusion set. Do not mix with immune globulin intravenous (IGIV) products from other manufacturers. Do not freeze. Solutions that have been frozen should not be used. Octagam 5% liquid bottle is for single use only. Octagam 5% liquid contains no preservative. Any bottle that has been entered should be used promptly. Partially used bottles should be discarded. 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 use after expiration date. Octagam 5% liquid should not be diluted. 2.2 Treatment of Primary Humoral ImmunodeficiencyAs 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 (6-12ml/kg) administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical responses.
If a patient is at risk of measles exposure (ie., outbreak in US or travel to endemic areas outside of the US) and receives a dose of less than 400 mg/kg every 3 to 4 weeks, the dose should be increased to at least 400 mg/kg. If a patient has been exposed to measles, this dose should be administered as soon as possible after exposure.
2.3 Missed DosesIf a patient on regular treatment missed a dose, the missed dose should be administered as soon as possible, and then treatment should continue as before.
2.4 AdministrationOctagam 5% liquid should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid and/or discoloration is observed.
Octagam 5% liquid should be at room temperature during administration. Only administer intravenously.
Any bottle that has been opened should be used promptly. Partially used bottles should be discarded.
Octagam 5% liquid 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). The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Rate of Administration
It is recommended that Octagam 5% liquid be initially infused at infusion rates stated below, at least until the physician has had adequate experience with a given patient.
Infusion rates: 0.5mg/kg/min (30mg/kg/hr for the first 30 minutes; if tolerated, advance to 1mg/kg/min (60mg/kg/hr) for the second 30 minutes; and if further tolerated, advance to 2mg/kg/min (120mg/kg/hr) for the third 30 minutes. Thereafter the infusion can be maintained at a rate up to, but not exceeding, 3.33mg/kg/min (200mg/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)/minute (200 mg/kg/hour).
Table 1
Rate of Administration mg/kg/min (mg/kg/hour) ml/kg/minfirst 30 min
0.5 (30)
0.01
next 30 min
1.0 (60)
0.02
next 30 min
2.0 (120)
0.04
Maximum
< 3.33 (<200)
<0.07
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.
Incompatibilities
Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparations in the same infusion set.
Shelf-life
Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.
Special Precautions for Storage
Do not freeze. Frozen product should not be used.
Do not use after expiration date.
![Octagam Immune Globulin (Human) (Immune Globulin) Solution [Octapharma Ab]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c906fa75-6235-032a-284f-cd0b93794ff9&name=img0002.jpg)
Login To Your Free Account