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. IGIV 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
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, chills, hypertension, rash, nausea and asthenia
- IV administration: Headache, cough, injection site reaction, nausea, pharyngitis and urticaria
- Subcutaneous administration: Infusion site reactions, headache, influenza, fatigue, arthralgia and pyrexia
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 four 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.