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Octagam Fact Sheet

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octagam fact sheet

Octagam Fact Sheet

Manufacturer: Octagam by OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.

Generic name: Human Immune globulin intravenous (IGIV)

 

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What is Octagam Infusion?

Octagam infusion is an intravenous immune globulin (IVIG) that contains high levels of antibodies derived from the plasma of healthy humans.  It is a sterile liquid preparation used to boost the body’s natural immune system to fight infections and protect the body against several diseases. 

 

IVIG therapy is given to immunocompromised persons who can not make sufficient antibodies to fight infections. 

 

Octagam IVIG is an FDA-approved therapy for chronic immune thrombocytopenic purpura (ITP) and primary humoral immunodeficiencies (PI), such as:

  • Congenital Agammaglobulinemia 
  • Common Variable Immunodeficiency
  • X-linked Agammaglobulinemia 
  • Wiskott-aldrich Syndrome 
  • Severe Combined Immunodeficiencies

 

Octagam infusion is available as Octagam 5% and Octagam 10% liquid preparation.

 

Side Effects

Common side effects of Octagam Infusion are:

  • Headache
  • Nausea
  • Fever
  • Increased Heart Rate (Reported With >5% Incidence) 

 

Serious Adverse Reactions Include:

  • Immediate Anaphylactic Reactions
  • Aseptic Meningitis
  • Thromboembolic Events
  • Hemolytic Anemia

 

Call your healthcare provider immediately if you have allergic reactions symptoms such as hives, difficulty in breathing, wheezing, neck stiffness, swelling in lips, tongue, throat, and dizziness.

 

Other side effects include:

  • Flushing
  • Chills
  • Fever
  • Nausea, Vomiting, Diarrhea, Abdominal Pain
  • Back Pain, Muscle Spamps
  • Chest Pain/Discomfort
  • Pain And Swelling At The Injection Site
  • Cough
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Who Should Avoid Octagam IVIG?

Octagam infusion should not be used by patients with a history of immune globulin allergy, corn allergy, and deficiency of immune globulin A (IgA) with IgA antibodies.

 

Octagam IVIG can cause thrombosis and renal dysfunction. 

 

Before Starting Octagam, Discuss With Your Health Care Provider If You Have/Are:

  • Kidney Disease
  • Heart Disease Or Blood Circulation Disorders
  • Diabetes
  • History Of Thrombosis And Stroke
  • Sepsis
  • Using Birth Control Pills
  • Paraproteinemia
  • Hyperproteinemia
  • Age Older Than 65 Years
  • Severe Illness And Bedridden
  • Using Indwelling Vascular Catheters
  • Pregnant

 

Warnings

Stop using  and seek medical attention if you observe the following symptoms:

  • Symptoms Of Clotting In The Brain
    • Such as vision and balance problems, confusion, weakness, and numbness. Monitor signs and symptoms of thrombosis.
  • Signs Of Clots In The Lungs And Heart
    • Such as cough with blood, difficulty in breathing, higher heart rate, wheezing and chest pain, etc.
  • Signs Of Clot Formation In Legs
    • Pain and swelling in legs.
  • Signs Of Kidney Problems
    • welling, urination problems. Monitor serum creatinine, blood urea nitrogen, and urine output.

 

What are the Uses?

Octagam infusion contains antibodies that are defensive substances against certain infectious agents. These antibodies fight and protect the body from infections. It also increases the number of platelets, thus used to treat blood disorders. IVIG therapy is also used for the treatment of muscle weakness problems and nerve disorders.

 

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Octagam IVIG Indications and Dosing

Infusion is available as Octagam 5% and Octagam 10% liquid preparation.

 

Octagam 5

Octagam 5 is a 5% sterile solution containing 50mg/ml of human immune globulin G (IgG). It is indicated for the treatment of primary humoral immunodeficiencies (PI), such as X-linked agammaglobulinemia, congenital agammaglobulinemia, and Wiskott-Aldrich syndrome and severe combined immunodeficiencies.

 

Octagam 5 is administered intravenously only. Its dose for primary humoral immunodeficiency (PI) is 300-600 mg/kg every 3-4 weeks with an initial infusion rate of 0.5 mg/kg/min and 3.33 mg/kg/min maintenance infusion rate if tolerated.

 

Octagam 5% liquid preparation available strengths: 1 g, 2.5 g, 5 g, 10 g or 25 g.

 

Octagam 10

Octagam 10 is a 10% sterile solution containing 100mg/ml of human immune globulin G (IgG). It is indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults. It prevents bleeding in adults by quickly increasing platelet count.

 

Octagam 10 is administered intravenously only. Its dose for the treatment of chronic immune thrombocytopenic purpura (ITP) is 1 g/kg daily for 2 consecutive days with an initial infusion rate of 1.0 mg/kg/min (0.01 mL/kg/min) and up to 12.0 mg/kg/min (Up to 0.12 mL/kg/min) maintenance infusion rate if tolerated.

 

Octagam 10% liquid preparation available strengths: 2 g, 5 g, 10 g, 20 g, or 30 g.

 

 

What is the Cost?

The cost of Octagam 5% intravenous sterile solution is $460.25 for 50ml ($9.21 per unit), and the cost of Octagam 10% solution is $370.10 for 20 ml ($18.51 per unit).

The cost of Octagam 5% intravenous solution is shown in the table below.

Quantity Per unit Price
50 ml $9.21 $460.25
100 ml $9.11 $910.99
200 ml $9.06 $1,812.49

 

 

The cost of Octagam 10% intravenous solution is shown in the table below.

Quantity Per unit Price
20 ml $18.51 $370.10
50 ml $18.22 $910.99
100 ml $18.12 $1,812.49
200 ml $18.08 $3,615.48
300 ml $18.06 $5,418.46

 

 

Copay Assistance Programs

A Copay Assistance program is sponsored by HealthWell foundation to assist patients by providing free or discounted medications to patients who meet the following eligibility criteria:

  1. Must be a resident of the USA
  2. Varies
  3. A disease diagnosis approved by the FDA
  4. May have insurance

Octagam infusion is included in this program.

For more details, please call or 800-675-8416 visit Website.

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