Gammaked Background

Patients with Chronic Inflammatory Demyelinating Polyneuropathy

WHAT IS CIDP?

CIDP (chronic inflammatory demyelinating polyneuropathy) is a neurological disorder characterized by progressive weakness, tingling, or numbness in the legs and arms. Symptoms are caused by damage to the myelin sheath—the protective covering around nerve fibers—in the nerves of arms and legs (peripheral nerves).Although the exact cause is not known, CIDP is considered an autoimmune disorder.1 In a healthy person, the body's immune system protects against disease by making antibodies to fight off infections caused by viruses and bacteria. In people with CIDP, the body's immune system mistakes myelin as foreign and attacks it.1 


 

Gammaked is FDA approved for treating CIDP

  • If you have CIDP and your healthcare provider recommends IGIV therapy, you will receive an infusion on a regularly scheduled basis
  • The infusion will most likely be given in your arm at a doctor's office, hospital or infusion center
    • In clinical studies, the most common adverse reactions with Gammaked were headache, fever, chills, hypertension, rash, nausea and fatigue3
    • The most serious adverse reaction was pulmonary embolism (PE) in one subject with a history of PE3
    • IGIV products have been associated with kidney disease.4 If you experience decreased urination, sudden weight gain, water retention, swelling, or shortness of breath (which could be symptoms of kidney disease), contact your doctor right away.3 IGIVs containing sugar stabilizers have caused the greatest number of kidney-related side effects.4 Gammaked contains no sugar and no preservatives3


CAUSES OF CIDP:

The cause of CIDP is not known. As a syndrome, different causes and triggers are likely. However, it is generally accepted that most, if not all, CIDP manifestations are autoimmune, triggered by infections or toxins in genetically susceptible individuals. The autoimmune nature of CIDP is suspected because of its occasional association with other immune-mediated diseases, such as systemic lupus and multiple sclerosis (MS), its response to immunosuppressive and immunomodulatory treatments, and pathologic findings on nerve biopsy. Other causes of neuropathy that may be difficult to distinguish from CIDP include:

  • Inherited neuropathy
  • Systemic inflammatory-autoimmune disorders
  • Dysproteinemias
  • Diabetes mellitus
  • Vasculitis
  • Other metabolic and toxic neuropathies

References: 1. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill; 2008. 2. Dorland's Illustrated Medical Dictionary, 27th ed. Philadelphia, PA: W.B. Saunders; 1988.   3. GAMMAKED [package insert]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2013. 4. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6:592-599.