Frequently Asked Questions

What is GAMMAKED?

GAMMAKED is a purified, sterile, ready-to-use 10% solution of human immunoglobulins. Immunoglobulins are isolated from human plasma and contain antibodies, proteins that play a major role in the immune response.

What is GAMMAKED used for? 

GAMMAKED is an intravenous immunoglobulin (IGIV) used as a “replacement” therapy for the treatment of primary humoral immunodeficiency diseases in which patients lack sufficient functioning antibodies to fight infections. GAMMAKED therapy is also used in the treatment of certain autoimmune and inflammatory disorders.

GAMMAKED is FDA-approved for the treatment of:

Chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
Primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to:
  • Congenital agammaglobulinemia
  • Common variable immunodeficiency
  • X-linked agammaglobulinemia
  • Wiskott-Aldrich syndrome
  • Severe combined immunodeficiencies
Idiopathic thrombocytopenic purpura (ITP) to raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery.
 

How is GAMMAKED administered?

GAMMAKED may be administered intravenously (IV) for all three approved uses. GAMMAKED may also be administered subcutaneously for the treatment of PI. 

What are the common side effects of GAMMAKED use?

The most common side effects with GAMMAKED, experienced in ≥ 5% of patients, include:

For CIDP: Headache, fever, increased blood pressure, chills, rash, nausea, joint pain, and weakness

For PI:
  • IV administration: Increased cough, stuffy nose, sore throat, headache, asthma, nausea, fever, diarrhea, and sinus infection
  • Subcutaneous administration: Swelling and itching at the injection site, fatigue, headache, upper respiratory infection, joint pain, diarrhea, nausea, sinus infection, bronchitis, depression, allergic skin reactions, migraine, muscle pain, viral infection, and fever
For ITP: Headache, bruising, vomiting, fever, nausea, rash, abdominal pain, back pain, and indigestion
 
For additional information, please see Important Safety Information, including Boxed Warning.
 

Who should not receive GAMMAKED?

Anyone who has known severe allergic reactions or severe responses to human immune globulin should not receive GAMMAKED. Patients should inform their healthcare professionals if they have experienced a serious reaction to other medicines that contain immune globulin.
Any patient who is immunoglobulin A (IgA) deficient with known antibodies against IgA and a history of hypersensitivity should not receive GAMMAKED. Patients should inform their healthcare professionals if they have an immunoglobulin A (IgA) deficiency.

After receiving GAMMAKED, what signs or symptoms should be reported immediately to a 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 

How is GAMMAKED supplied?

GAMMAKED is supplied in single-use, tamper-evident vials (shrink band) containing the labeled amount of functionally active IgG. The three larger vial size labels incorporate integrated hangers. GAMMAKED is not made with natural rubber latex. 

 

 
                     Vial Sizes                      Grams of Protein                NDCs
                     10 mL                      1 g                      76125-900-01
                     25 mL                      2.5 g                      76125-900-25
                     50 mL                      5 g*                      76125-900-50
                     100 mL                      10 g*                      76125-900-10
                     200 mL                      20 g*                      76125-900-20

*Vials with integrated hangers 

How is GAMMAKED stored?

Do not freeze GAMMAKED. GAMMAKED may be stored for 36 months at 2 – 8oC (36 – 46oF) from the date of manufacture, and GAMMAKED may be stored at temperatures not to exceed 25oC (77oF) for up to 6 months any time during the 36-month shelf life, after which GAMMAKED must be used immediately or discarded. Do not use GAMMAKED after the expiration date.

Whom do I call for questions about GAMMAKED, reimbursement issues or customer service?

The Kedrion Biopharma Customer Service team at 1-855-353-7466 is available to assist you with medical inquiries, reimbursement questions and customer service. 

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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) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

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) may occur 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:
                    - Increased cough, stuffy nose, sore throat, headache, asthma, nausea, fever, diarrhea, and sinus
                    infection, when administered intravenously to patients with PI. 

                    - Swelling and itching at the injection site, fatigue, headache, upper respiratory infection, joint pain,
                    diarrhea, nausea, sinus infection, bronchitis, depression, allergic skin reactions, migraine, muscle
                    pain, viral infection, and fever, when administered subcutaneously to patients with PI.

                  - Headache, bruising, vomiting, fever, nausea, rash, abdominal pain, back pain, and indigestion
                    in patients with ITP.

                  - Headache, fever, increased blood pressure, chills, rash, nausea, joint pain, 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 effect.
  • 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.

©2018 Kedrion Biopharma Inc. All Rights Reserved. June 2018 GM-0110-03-2018