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

Efficacy

​​​Dermatomyositis (DM)
DM
Study design
DM
​​​​​​​Study endpoints overview
DM
Primary endpoints (TIS improvement)
 
DM
​​​​​​​Secondary endpoints (CDASI improvement)
 

OCTAGAM 10% demonstrated a higher responder rate* vs placebo in all 3 categories of TIS improvement at 4 months1

Primary endpoint met: a significantly higher proportion of patients receiving OCTAGAM 10% achieved at least the minimal category of TIS improvement vs. placebo (79% vs 44%; P=0.0008)1

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  •  In both the moderate and major improvement categories, there were higher proportions of responders with OCTAGAM 10% vs placebo (secondary endpoints)1
  •  Median time to response in the OCTAGAM 10% treatment arm was 35 days (after 2 infusions)1

*A responder was defined as a patient with a TIS improvement of ≥20 points (at least minimal improvement), ≥40 points (at least moderate improvement), ≥60 points (major improvement) who had not met criteria for confirmed deterioration at 2 consecutive visits up to and including week 16. The proportion of responders in the OCTAGAM 10% vs placebo arms, respectively, was 78.7% (37/47 patients) vs 43.8% (21/48 patients) for minimal TIS improvement; 68.1% (32/47 patients) vs 22.9% (11/48 patients) for moderate TIS improvement; 31.9% (15/47 patients) vs 8.3% (4/48 patients) for major TIS improvement.

Learn more about TIS endpoint  

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

After patients switched from placebo to OCTAGAM 10%, both treatment arms achieved similar mean TIS at 10 months2

At 4 months, there were greater improvements in mean TIS in the OCTAGAM 10% arm vs placebo arm2

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  • Mean TIS is a secondary endpoint which is different than the primary  endpoint  of TIS responder rate2*†   ​​​​​
    ​​​​​​​⁃  TIS values were collected at each visit through week 16, then at week 28, and at week 40. Mean TIS values for both treatment arms are shown in the graph
    2

 *Mean TIS is defined as the average TIS values collected from baseline to week 16 then at week 28 and week 40.
TIS responder rate is the proportion of patients achieving a TIS improvement of ≥20 points (at least minimal improvement), ≥40 points (at least moderate improvement), ≥60 points (major improvement).

 

See CDASI results from the clinical study

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

 
DM safety and tolerability data 
for OCTAGAM 10%
 

Administration Video

Review data

 DM dosing and infusion rates 
for OCTAGAM 10% 
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Resources for patients and HCPs

See details 

 
OCTAGAM 10% DM clinical 
results video
 

Resources for patients and HCPs

Watch here 

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 recieving 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.

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.
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OCTAGAM® is a registered trademark of Octapharma AG.

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

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.

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.