octagam(R) 10% Immune Globulin Intravenous(Human) 10% Liquid Preparation

Dosing and Administration

Total infusion time for OCTAGAM 10% based on rate of infusion for adult patients with cITP

A range of infusion rates, starting at 1 mg/kg/min up to a maximum of ≤12 mg/kg/min, as tolerated​​​​​​​1

   *The figure above is based on the ramp-up schedule for OCTAGAM 10% valid for a 70-kg patient receiving a 1 g/kg dose.1​​​​​​​

It is recommended that OCTAGAM 10% be started at 1 mg/kg/min and can be dosed at the infusion rates shown below, if the previous rate is tolerated1*

Dosing and rate of administration1​​​​​​​

Dose

Initial infusion rate

Maintenance infusion rate (if tolerated)

1 g/kg daily for 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)


​​​​​​​Infusion rate increases (based on tolerability)1

Rate of administration

mg/kg/min (mg/kg/hr)

mL/kg/min

First 30 minutes

1 (60)

0.01

Next 30 minutes  (if above is tolerated)

2 (120)

0.02

Next 30 minutes  (if above is tolerated)

4 (240)

0.04

Next 30 minutes  (if above is tolerated)

8 (480)

0.08

Maximum

12 (720)

0.12 

  • 60% (54 of 90) patients achieved the maximum infusion rate allowed at 12 mg/kg/min in the cITP clinical study1
  • Monitor the patient carefully throughout the infusion1​​​​​​​
    • 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
  • 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/min1

Preparation and handling of OCTAGAM 10%: DOs and DON’Ts1

DO

  • DO visually inspect OCTAGAM 10% for particulate matter and discoloration before using (if the solution and container permit).1
  • DO use right away after the bottle has been entered or opened, and throw away partially used bottles. OCTAGAM 10% contains no preservatives—it is for single use only.1
  • DO pool the contents of OCTAGAM 10% bottles under aseptic conditions with sterile infusion bags and infuse within 8 hours after pooling.1
  • DO administer OCTAGAM 10% at room temperature, only by the IV route.1
  • DO select (if using) an in-line filter with a pore size of 0.2-200 microns. OCTAGAM 10% is not supplied with an infusion set.1
  • DO insert the needle only once within the delineated stopper area.1
  • DO penetrate the stopper perpendicular to its plane and within the ring.1

DON'T

  • ​​​​​​​DON’T use if turbid and/or discolored.1
  • DON’T mix with other medicinal products.1
  • DON’T administer with other IV preparation in the same infusion set.1
  • ​​​​​​​DON’T mix with other IVIg products.1
  • DON’T freeze OCTAGAM 10%.
  • DON’T use if OCTAGAM 10% is frozen.1
  • DON’T use after expiration date.1
  • DON’T dilute OCTAGAM 10%.1
  • DON’T use a needle larger than 16 gauge to prevent the possibility of coring.1

Safety and tolerability were evaluated in a clinical study1

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Reference:
  1. OCTAGAM 10% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2021.

Dosing

  • Dosing and Administration
  • Octagam 10% Administration Video

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Administering OCTAGAM 10%

Administration Video

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Negative side effects of prescription drugs should be reported to Pfizer Inc. at 1‑800‑438‑1985 or to the FDA. Visit www.fda.gov/MedWatch , or call 1‑800‑FDA‑1088.
OCTAGAM® is a registered trademark of Octapharma AG.

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin intravenous (IgIV) products, including OCTAGAM 10% 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 10% 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 10% liquid does not contain sucrose.
  • For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 10% 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.

Dosing and Administration
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.

Contraindications
OCTAGAM 10% 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.

Warnings and Precautions
OCTAGAM 10% liquid may cause hypersensitivity in patients with a corn allergy. OCTAGAM 10% liquid contains maltose, which is derived from corn.

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 10% liquid with testing by some glucometers and test strip systems.

Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving OCTAGAM 10% liquid.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to treatment with OCTAGAM 10% liquid. Risk factors for hemolysis include high doses and non–O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Aseptic meningitis syndrome may occur in patients receiving OCTAGAM 10% liquid, especially with high doses or rapid infusion.

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

OCTAGAM 10% liquid is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Adverse Reactions
cITP - The most common adverse reactions reported in >5% of study subjects were headache, fever, and increased heart rate.

DM - The most common adverse reactions reported in >5% of study subjects were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions.

OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.

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

INDICATIONs and Usage

OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.

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