Gammaked Background

Safety of GAMMAKED:

Understanding The Side Effects

You want a therapy that helps you stay healthy and feel your best. That's why it's important to understand the side effects associated with any drug you take. Contact your doctor right away if you experience any of these signs or symptoms, which could be signs or symptoms of kidney disease1:

  • Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath
  • Symptoms of thrombosis which may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body
  • Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting
  • Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine
  • Trouble breathing, chest pain, blue lips or extremities, and fever 

The most common adverse reactions obvserved in CIDP, PI, and ITP are: 

CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY:

The most common adverse reactions observed at a rate ≥ 5% in subjects with Gammaked for chronic inflammatory demyelinating polyneuropathy (CIDP) were headache, fever, chills, high blood pressure, rash, nausea and fatigue.


PRIMARY IMMUNODEFICIENCY:

The most common adverse reactions observed at a rate ≥ 5% in subjects treated with IV Gammaked for primary immunodeficiency (PI) were headache, injection site reaction, nausea, sore throat and hives.1

The most common adverse reactions observed at a rate ≥ 5% in subjects treated with subcutaneous (SC) dosing of Gammaked for primary immunodeficiency (PI) were infusion site reactions, headache, fatigue, joint pain and fever.1


IDIOPATHIC THROMBOCYTOPENIC PURPURA:

The most common adverse reactions observed at a rate ≥ 5% in subjects treated with Gammaked for idiopathic thrombocytopenic purpura (ITP) were headache, vomiting, fever, nausea, back pain and rash.1


The most serious side effects with Gammaked in clinical trials were1:

  • Lung artery blockage (pulmonary embolism) in one patient with a history of this condition
  • Exacerbation of a red blood cell disorder (autoimmune pure red cell aplasia) in one patient
  • Heart inflammation (myocarditis) in one patient that occurred 50 days after infusion and was not considered drug related

IGIV products have been associated with kidney disease1,2

If you have diabetes, kidney disease, or heart-related problems, you should know that some IGIV products contain sugar, salt or other preservatives that may increase the risk of serious side effects.2 


What else should I know about Gammaked?

Immunoglobulin therapies (IGIV) containing sugar stabilizers have caused the greatest number of kidney-related side effects.1,2 Gammaked contains no sugar and no preservatives.1 

All IGIV products, including Gammaked, can have serious side effects including fluid in the lungs not caused by heart disease (sometimes referred to as transfusion-related acute lung injury [TRALI]). There have also been rare cases of: low red blood cell count, inflammation of the membranes that surround the brain (aseptic meningitis), blood clotting, and blood vessel blockage, high protein content in the blood (hyperproteinemia), thickening of the blood (increased serum viscosity) and low levels of sodium in the blood (hyponatremia) may occur in patients receiving IGIV therapy.

If you are 65 years of age or older, have type 2 diabetes, kidney problems, hardening of the arteries or heart disease, be sure to tell your doctor prior to starting any IGIV therapy.1 


WARNING: ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE MAY OCCUR1 

  • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinema, or patients receiving known nephrotoxic drugs
  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaked does not contain sucrose
  • For patients at risk of renal dysfunction or failure, administer Gammaked at the minimum concentration available and the minimum infusion rate practicable
References1. GAMMAKED [package insert]. Fort Lee, NJ. Kedrion Biopharma Inc., 2013. 2. Gelfand EW. Differences between IGIV products: impact on clinical outcome. Int Immunopharmacol. 2006;6:592-599.