Gammaked Background

Frequently Asked Questions

What is Gammaked?

GAMMAKED is an immunoglobulin used to treat primary immune deficiency (PI). Immunoglobulin is another name for the purified antibodies from human plasma that defend the body against infections such as viruses and bacteria. People with PI lack the healthy antibodies needed to fight off these infections. GAMMAKED provides those healthy antibodies and will help lower the number and severity of infections you could get.

Important Safety Information for Gammaked:

GAMMAKED is not approved for subcutaneous use in patients with ITP or CIDP. Due to the potential risk of hematoma formation, GAMMAKED should not be administered subcutaneously in patients with ITP. 

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy. There have been reports of noncardiogenic pulmonary edema [Transfusion- Related Lung Injury (TRALI)], hemolytic anemia, and aseptic meningitis in patients administered with IGIV. The high dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

GAMMAKED is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.

In clinical studies, the most common adverse reactions with GAMMAKED were headache, fever, chills, hypertension, rash, nausea, and asthenia (in CIDP); headache, cough, injection site reaction, nausea, pharyngitis, and urticaria with intravenous use (in PI) and infusion site reactions, headache, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP). The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in one subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in one subject (in PI), and myocarditis in one subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).

Where does Kedrion Biopharma manufacture Gammaked? 

Gammaked is manufactured by Grifols Therapeutics, Inc., and distributed by Kedrion Biopharma Inc., in the US. 

Where does Gammaked get its plasma? 

All plasma-derived medication approved in the US are sourced from US donor centers. 

Gammaked is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 

What are the indications and usage for Gammaked? 

Gammaked has three FDA-approved indications. Listed below are the indications: 

Primary Immunodeficiency (PI) – Gammaked is indicated for replacement therapy in primary immunodeficiency. This includes, but is not limited to: 

    • Congenital agammaglobulinemia
    • Common variable immunodeficiency
    • X-linked agammaglobulinemia
    • Wiskott-Aldrich syndrome
    • Severe combined immunodeficiency

Idiopathic Thrombocytopenia Purpura (ITP)

    • Gammaked is indicated for the treatment in ITP to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    • Gammaked is indicated for the treatment of CIDP to improve neuromuscular disability and impairment, and for maintenance therapy to prevent relapse.

As with any of these indications, please consult with a medical clinician for further information and prescriptions.

How is Gammaked administered?

Gammaked  is approved for  intravenous use  in all three indications. However, for the PI patient, Gammaked may also be administered subcutaneously. Gammaked is NOT approved for subcutaneous administration for ITP or CIDP.  Please consult with your clinical professional for more information.

How is Gammaked dosed? 

Dosing varies by indication, the patient, and the patient’s individual tolerance of Gammaked infusions. The initial infusion of Gammaked should be administered slowly, and the rate titrated upwards every 30-45 minutes as the patient tolerates.  Some patients can tolerate more rapid infusions than others. Titration of the dosing rate should be done only under the supervision of an experienced health care provider.

How is Gammaked supplied? 

Gammaked is supplied in a single-use, tamper evident (shrink band) containing the labeled amount of functionally active IgG.  The three larger vials sizes incorporate integrated hangers. The components used in the packaging of Gammaked are latex free.  

Gammaked is supplied in the following sizes:

NDC# GRAMS SOLUTION USAGE
76125-900-01 1 g 10 mL Single Use
76125-900-25 2.5 g 25 mL Single Use
76125-900-50 5 g 50 mL Single Use
76125-900-10 10 g 100 mL Single Use
76125-900-20 20 g 200 mL Single Use

 

Light blue shading strengths come with integrated hangers. 

How is Gammaked stored? 

  • Gammaked may be stored for 36 months at 2-8⁰ C (36 - 46⁰F). The product may be stored at temperatures not to exceed 25⁰ C (77⁰F) for up to 6 months anytime during the 36-month shelf life after which the product must be immediately used or discarded.
  • DO NOT FREEZE
  • Do not use after expiration date

What signs or symptoms need to be reported immediately to a healthcare provider?

  • 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 

Whom do I call for medical inquiries, reimbursement and customer service? 

Please call 1-885-353-7466. Kedrion's Customer Service will be able to assist you with any medical inquiries, and for your convenience, any customer service or reimbursement issues can be handle at this number also.