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

Safety and Tolerability

Safety and tolerability of OCTAGAM 10% administered at 1 g/kg daily over 2 consecutive days for adult patients with cITP1

The most common adverse reactions observed with OCTAGAM 10% treatment were headache, pyrexia, and increased heart rate1*​​​​​​​​​​


  * Ready-to-use OCTAGAM 10% was investigated in a prospective phase 3 study of 116 adult patients with ITP (platelet count ≤20 x 109/L). Sixty-six patients had cITP and 49 were newly diagnosed. Patients received OCTAGAM 10% 1 g/kg/day on 2 consecutive days, and the infusion rate was adjusted according to tolerability to a maximum of 12 mg/kg/min. The primary efficacy variable was the attainment of a clinical response, defined as an increase in platelet count to ≥50 x 109/L within 6 days of dosing. Secondary efficacy variables included the time to achieve a clinical response, the maximum platelet level achieved, assessment of bleeding, and the duration of platelet response.1
​​​​​​​

  • No patient withdrew from the study due to a drug-related adverse event2
  • One patient experienced a serious adverse reaction (headache)1​​​​​​​
  • ​​​​​​​0.9% (1 of 116) of patients received premedication in this study1†​​​​​​​​​​​​​​​​​​​​​

​​​​​​​​​​​​​​​​​​Premedication to alleviate potential adverse drug reactions was allowed.​​​​​​​​​​​​​​
​​​​​​​​​​​​​​

Available in 5 vial sizes
​​​​​​​
help meet patients' Ig treatment needs1

Lorem ipsum dolor sit amet

More product information

References:
  1. OCTAGAM 10% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2021.
  2. Data on file. Octapharma USA Inc.

Efficacy & Safety

  • Efficacy
  • Safety and Tolerability

Administering OCTAGAM 10%

Administration Video

Watch video now

** This is an optional area where footnotes can live.

Resource Library

The card body Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam.

Go to the resource library

** This is an optional area where footnotes can live.


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.