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

Further information

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