Common Side Effects

In clinical studies, the most common side effects of GAMMAKED were:

PI:

> Intravenous: Headache, cough, injection site reaction, nausea, sore throat and rash.
Subcutaneous: Redness, swelling and itching at the injection site, headache, influenza, fatigue, pain (including pain in the back, joints, arms, legs) and fever.

ITP: Headache, vomiting, fever, nausea, back pain and rash.
CIDP: Headache, fever, chills, high blood pressure, rash, nausea and weakness.

The most serious adverse reactions were pulmonary embolism (blood clot in the lungs) or 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).

After receiving GAMMAKED, the following signs or symptoms should be reported immediately to your healthcare professional: 

  • 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 

Please click here for the full Important Safety Information, including Boxed Warning. 

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Important Safety Information

APPROVED USES
GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is approved to treat Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older, Idiopathic Thrombocytopenic Purpura (ITP), and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

GAMMAKED may cause: 

1. Blood Clots (Thrombosis). Blood clots may occur in patients taking immune globulin intravenous (IGIV) products, including GAMMAKED. You may be at greater risk for blood clots if you are of advanced age, sit or lie for long periods, have a clotting condition or a history of blood clots, take estrogen hormones, have a central catheter, have thick blood, and/or if you have other conditions that put you at risk for cardiovascular disease. Blood clots may occur even if you do not have any of these known risk factors. 
2. Impaired kidney function or kidney failure. IGIV products, particularly those that contain sugar (sucrose), have been reported to be associated with kidney dysfunction and damage, kidney failure, and death. Kidney damage and kidney failure happen more often in patients receiving IGIV products containing sucrose. GAMMAKED does not contain sucrose. You may be at greater risk for kidney failure if you have kidney disease, diabetes, are over age 65, are seriously dehydrated, have a blood infection (sepsis), have a blood condition called paraproteinemia, or take drugs that can damage your kidneys.

  • Do not use GAMMAKED if:
                    - You have a history of severe allergic reactions to human immune globulin. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human immune globulin. Ask if you are not sure.

                    - You have an immunoglobulin A (IgA) deficiency and have antibodies to IgA and have a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.
  • Severe allergic reactions may occur with IGIV products, including GAMMAKED. IgA deficient patients who have antibodies against IgA are at greater risk of developing severe allergic reactions. Your healthcare provider should have medications, such as epinephrine, to immediately treat any sudden severe allergic reactions.
  • If you are receiving GAMMAKED, you could experience higher than normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.
  • Brain inflammation or brain swelling called Aseptic Meningitis Syndrome (AMS) has been reported infrequently with IGIV products, including GAMMAKED, especially if you receive a high dose or a rapid infusion.
  • Blood damage called hemolysis and hemolytic anemia can develop after treatment with GAMMAKED. Your healthcare provider will monitor you for signs and symptoms of hemolysis and hemolytic anemia.
  • Swelling of the lungs may occur in patients following IGIV treatment, including GAMMAKED. Your healthcare provider will monitor you for signs of lung damage (also known as transfusion-related acute lung injury [TRALI]).
  • GAMMAKED is made from human blood and, therefore, carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.
  • Be sure to tell your healthcare provider about your recent history of vaccinations.  Live vaccines for disease like measles, mumps, rubella and varicella may not work as well for you while you are receiving GAMMAKED. Tell your healthcare provider that you are taking GAMMAKED before you receive any vaccination.
  • In clinical studies, the most common side effects of GAMMAKED were:
                    - Headache, cough, injection site reaction, nausea, sore throat, and rash, when administered intravenously to patients with PI.

                    - Redness, swelling and itching at the injection site, headache, influenza, fatigue, pain (including pain in the back, joints, arms, legs) and fever, when administered subcutaneously to patients with PI.
                  - Headache, vomiting, fever, nausea, back pain, and rash in patients with ITP.
                  - Headache, fever, chills, high blood pressure, rash, nausea, and weakness in patients with CIDP.
  • During treatment with GAMMAKED, be sure to tell your healthcare provider about any unusual symptoms you experience as they may indicate a possible side effects.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch, or call 1-800-FDA-1088. 

Please click here for the GAMMAKED Full Prescribing Information.

©2017 Kedrion Biopharma Inc. All Rights Reserved. September 2017 GM-0110-02-2017