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About OCTAGAM 5%

Preparation, storage and handling

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Dosing & Infusion Rates

Dosing and rate of administration

Dosing and rate  of administrationTotal infusion timeInfusion rate chart

OCTAGAM 5% is for intravenous use only for the treatment of primary immunodeficiency (PI)1​​​​​​​

Infusion rate increases (based on tolerability)1

  • The initial infusion rate of 0.5 mg/kg/min should be maintained for the first 30 minutes; if tolerated, advance to 1 mg/kg/min for the next 30 minutes; and if still tolerated, advance to 2 mg/kg/min for the next 30 minutes. If tolerated the infusion rate can be increased to and maintained at a maximum rate of 3.33 mg/kg/min1
  • 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 promptly1
  • Ensure that patients with preexisting renal insufficiency are not volume depleted1
    – Discontinue OCTAGAM 5% if renal function deteriorates1
  • For patients at risk of renal dysfunction or thrombotic events, administer OCTAGAM 5% at the minimum infusion rate practicable1

Administration of OCTAGAM 5%1

  • OCTAGAM 5% should be used at room temperature. Only administer intravenously
  • OCTAGAM 5% 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 larger than 16 gauge to prevent the possibility of coring. Insert the 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
  • Contents of OCTAGAM 5% bottles may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling

Drug interactions1

  • OCTAGAM 5% should not be mixed with other drugs or medications
Reference
  1. ​​​​​​​OCTAGAM 5% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2019

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See efficacy & safety data for OCTAGAM 5%

Review the data
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
    • ​​​​​​​Thrombosis may occur with immune globulin intravenous (IgIV) products, including OCTAGAM 5% liquid.​​​​​​​ 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.
    • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IgIV products, including OCTAGAM 5% liquid. 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 products containing sucrose. OCTAGAM 5% liquid does not contain sucrose.
    • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 5% liquid 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.

     
    OCTAGAM 5% liquid is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.

    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.

    Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.

    Falsely elevated blood glucose readings may occur during and after the infusion of OCTAGAM 5% liquid with testing by some glucometers and test strip systems.

    Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving OCTAGAM 5% liquid.

    Aseptic meningitis syndrome may occur in patients receiving OCTAGAM 5% liquid, especially with high doses or rapid infusion.

    Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to treatment with OCTAGAM 5% liquid. Risk factors for hemolysis include high doses and non–O–blood group. Closely monitor patients for hemolysis and hemolytic anemia.

    Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

    OCTAGAM 5% liquid is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

    The most common adverse reactions reported in >5% of subjects during a clinical trial were headache and nausea. The most serious adverse reactions in treatment with OCTAGAM 5% liquid have been immediate anaphylactic reactions, aseptic meningitis, and hemolytic anemia.

    You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

    OCTAGAM® is a registered trademark of Octapharma AG.

    Please click here for Full Prescribing Information, including BOXED WARNING.

    OCTAGAM® 5% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of primary humoral immunodeficiency (PI).

    INDICATION AND USAGE

    OCTAGAM® 5% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of primary humoral immunodeficiency (PI).

    Please click here for Full Prescribing Information, including BOXED WARNING.

      Please see full Prescribing Information including BOXED WARNING.

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