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Octagam FDA Approval History

Last updated by Judith Stewart, BPharm on July 22, 2021.

FDA Approved: Yes (First approved May 21, 2004)
Brand name: Octagam
Generic name: immune globulin intravenous (human)
Dosage form: Injection
Company: Octapharma USA, Inc.
Treatment for: Primary Immunodeficiency Syndrome, Idiopathic Thrombocytopenic Purpura, Dermatomyositis

Octagam (immune globulin intravenous (human)) is a ready-to-use immunoglobulin intravenous (IGIV) product indicated for the treatment of primary humoral immunodeficiency, chronic immune thrombocytopenic purpura (ITP) and dermatomyositis.

  • Octagam is available in two strengths:
    • Octagam 5% is indicated for treatment of primary humoral immunodeficiency (PI).
    • Octagam 10% is indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) and dermatomyositis (DM) in adults.
  • Octagam is administered via intravenous infusion.
    • Octagam 5% for PI is administered every 3-4 weeks.
    • Octagam 10% for ITP is administered over 2 consecutive days.
    • Octagam 10% for DM is administered over 2-5 consecutive days every 4 weeks.
  • The Octagam product labels carry warnings for an increased risk of thrombosis, renal dysfunction or acute renal failure.
  • Common adverse reactions for Octagam 5% include headache and nausea.
  • Common adverse reactions for Octagam 10% when used for chronic ITP include headache, fever and increased heart rate. Common adverse reactions for Octagam 10% when used for dermatomyositis include headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions.

Development Timeline for Octagam

DateArticle
Jul 20, 2021Approval  FDA Approves Octapharma’s Octagam 10% for Adult Dermatomyositis
Jul 17, 2014Approval  Octapharma USA Announces FDA Approval of Octagam 10% for the treatment of Chronic Immune Thrombocytopenic Purpura (ITP)
May 24, 2004Approval  FDA Approves Octagam 5% for the for the Treatment of Primary Immunodeficiency Diseases

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.