Gammaked Background

Important Safety Information

HIGHLIGHTS OF THE PRESCRIBING INFORMATION
These highlights do not include all the information needed to use GAMMAKED safely and effectively. See full prescribing information for GAMMAKED.
GAMMAKED, [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified]
Initial U.S. Approval: 2003

INDICATIONS AND USAGE

GAMMAKED is an immune globulin injection (human) 10% liquid indicated for treatment of:

  • Primary Humoral Immunodeficiency (PI)
  • Idiopathic Thrombocytopenic Purpura (ITP)
  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

CONTRAINDICATIONS

  • Anaphylactic or severe systemic reactions to human immunoglobulin
  • IgA deficient patients with antibodies against IgA and a history of hypersensitivity

WARNINGS AND PRECAUTIONS

  • IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.
  • Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of developing acute renal failure.
  • Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy.
  • Thrombosis has occurred in patients receiving IGIV therapy. Monitor patients with known risk factors for thrombosis; consider baseline assessment of blood viscosity for those at risk of hyperviscosity.
  • Aseptic Meningitis Syndrome (AMS) has been reported with GAMMAKED and other IGIV treatments, especially with high doses or rapid infusion.
  • Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration. Monitor patients for hemolysis and hemolytic anemia.
  • Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
  • Volume overload.
  • GAMMAKED is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
  • GAMMAKED is not approved for subcutaneous use in ITP patients. Due to a potential risk of hematoma formation, do not administer GAMMAKED subcutaneously in patients with ITP.
  • Passive transfer of antibodies may confound serologic testing. 

ADVERSE REACTIONS

Serious adverse reactions which occurred in the clinical trials were an exacerbation of autoimmune pure red cell aplasia in one subject and pulmonary embolism in one subject with a history of PE. The most common adverse reactions observed in ≥5% patients were:

PI: Intravenous: Headache, cough, injection site reaction, nausea, pharyngitis and urticaria.
       Subcutaneous: Infusion site reactions, headache, fatigue, arthralgia and pyrexia.

ITP: Headache, vomiting, fever, nausea, back pain and rash.

CIDP: Headache, fever, chills, hypertension, rash, nausea and asthenia. 

To report ADVERSE REACTIONS OR SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics Inc. at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.  

DRUG INTERACTIONS

  • The passive transfer of antibodies may transiently interfere with the response to live viral vaccines, such as measles, mumps and rubella.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: No human or animal data. Use only if clearly needed
  • Geriatric: In patients over 65 years old of age, do not exceed the recommended dose, and infuse GAMMAKED at the minimum infusion rate practicable.
 
Gammaked is manufactured by Grifols Therapeutics Inc.                            Kedrion Biopharma Inc
Research Triangle Park, NC 27709 USA                                                      400 Kelby Street, Fort Lee, NJ 07024