Octagam Immune Globulin (Human)
OCTAGAM IMMUNE GLOBULIN (HUMAN)- human immunoglobulin g solution
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
INDICATIONS AND USAGE
Primary Humoral Immunodeficiency Diseases (PI)
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.
DOSAGE AND ADMINISTRATION
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 Immunodeficiency
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 (6-12ml/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.
If 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.
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 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).
|Rate of Administration||mg/kg/min (mg/kg/hour)||ml/kg/min|
first 30 min
next 30 min
next 30 min
< 3.33 (<200)
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.
Octagam 5% liquid must not be mixed with other medicinal products or administered simultaneously with other intravenous preparations in the same infusion set.
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.
DOSAGE FORMS AND STRENGTHS
Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g , 10 g or 25 g single use bottles (See How Supplied/Storage and Handling ).
Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin.
Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description ).
Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid.
WARNINGS AND PRECAUTIONS
Severe hypersensitivity reactions may occur [ 1 ] (See Contraindications [4.1]). In case of hypersensitivity, Octagam 5% liquid infusion should be immediately discontinued and appropriate treatment instituted. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reaction. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactoid reactions when administered Octagam 5% liquid (See Contraindications [4.2]). Patients known to have corn allergies should avoid using Octagam 5% liquid (See Contraindications [4.3]).
Assure that patients are not volume depleted prior to the initiation of the infusion of Octagam 5% liquid.
Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential increased risk of developing acute renal failure. Renal function, including a measurement of blood urea nitrogen (BUN)/serum creatinine, should be assessed prior to the initial infusion of Octagam 5% liquid and again at appropriate intervals thereafter. If renal function deteriorates, discontinuation of the product should be considered (See Patient Counselling Information )
For patients judged to be at risk for developing renal dysfunction and/or at risk of developing thrombotic events, it may be prudent to reduce the amount of product infused per unit time by infusing Octagam 5% liquid at a maximum rate less than 0.07 ml/kg (3.3 mg/kg)/minute (200 mg/kg/hour) (See Boxed Warning, and Dosage and Administration [2.4]).
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