Gammaked Background

Manufacturing Process

GAMMAKED IS PRODUCED BY USING A UNIQUE, CAPRYLATE/CHROMATOGRAPHY PURIFICATION PROCESS:

  • Requires no sugar stabilizer

 

THE GAMMAKED PROCESS HAS DEMONSTRATED THE ABILITY TO REMOVE PRIONS:

  • Zero confirmed cases of virus or prion disease transmission, including the human form of bovine spongiform encephalopathy (mad cow disease)
  • Proven pathogen safety steps
      • 5 virus removal/inactivation steps1
      • 2 depth filtrations in sequence provide prion removal1
      • Removal/inactivation of emerging pathogens (e.g., West Nile virus)1

Because Gammaked is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.


Adverse Reactions:

In clinical studies, the most common adverse reactions with Gammaked were headache, fever, chills, hypertension, rash, nausea, and fatigue (in CIDP); headache, cough, injection site reaction, nausea, sore throat and hives (in PI); and headache, vomiting, fever, nausea, back pain and rash (in ITP).1

The most serious adverse reactions were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of red blood cell disorder in one subject (in PI) and heart inflammation in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).1

 

Reference: 1. GAMMAKED [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2013.