ICE Study Results

1. GAMMAKED improved physical functioning in CIDP
[Efficacy period (weeks 0-24)]

Responders defined as patients who maintained
an improvement of ≥ 1 point in adjusted INCAT
disability score through week 24 

‡Participants were assessed using the SF-36 health survey.
Domain scores were recorded at screening and at the
end of each period.

> Physical functioning (includes ability to walk or climb stairs)3
> Role-physical (activities of daily living, including work)
3

 

1. Continued improvement seen over the full 24 weeks4
[Efficacy period (weeks 0-24)]

Among CIDP patients who responded* to GAMMAKED

       > 47% initially responded by week 3
       > 53% initially responded by week 6

> The number of patients receiving their maximal improvement continued to increase for the full duration of GAMMAKED therapy (24 weeks) 
> Discontinuing GAMMAKED treatment before maximal improvement is achieved may deprive patients the therapeutic benefit, such as the abilities to walk or dress unaided5

* Responders were defined as patients who maintained an improvement of ≥ 1 point in adjusted INCAT disability score through week 24
An individual patient’s maximal INCAT disability score over the course of the ICE Study

2. Long-term GAMMAKED administration can lower probability of relapse in CIDP1
[Extension Phase (weeks 24-48)]


Withdrawal of therapy (re-randomization to placebo)
increased risk of relapse1


  Patients who continued to receive GAMMAKED experienced
a longer time to relapse1

Adverse reactions in CIDP1

In clinical studies, the most common adverse reactions with GAMMAKED (≥5% of subjects) were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia.


References: 1. GAMMAKED [prescribing information]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2017. 2. Merkies ISJ, Bril V, Dalakas MC, et al. Health-related quality-of-life improvements in CIDP with immune globulin IV 10%: The ICE Study. Neurology. 2009;72:1337-44. 3. McHorney CA, Ware JE Jr., Lu JFR, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32:40-66. 4. Latov N, Deng C, Dalakas MC, et al, for the IGIV-C CIDP Efficacy (ICE) Study Group. Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory  demyelinating polyradiculoneuropathy. Arch Neurol. 2010;67(7):802-807. 5. Merkies ISJ, Schmitz PIM, van der Meche FGA, et al, for the INCAT group. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002;72:596-601.

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Important Safety Information

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.

Boxed Warning: Thrombosis, Renal Dysfunction and Acute Renal Failure

  • Thrombosis may occur with immune globulin products, including GAMMAKED. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
  • For patients at risk of thrombosis, administer GAMMAKED at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
  • 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, paraproteinemia, 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.

GAMMAKED is contraindicated in patients who have had an anaphylactic or severe systemic reaction to human immunoglobulin. It is also contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy, including GAMMAKED.

Aseptic Meningitis Syndrome (AMS) may occur infrequently, especially with high doses or rapid infusion.

Hemolysis, either intravascular or due to enhanced red blood cell (RBC) sequestration, can develop subsequent to GAMMAKED treatment. Risk factors include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia, especially in patients with pre-existing anemia and/or cardiovascular or pulmonary compromise.

Noncardiogenic pulmonary edema may occur in patients following treatment with IGIV products, including GAMMAKED. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

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, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

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

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 (≥5% of subjects) were: (in PI intravenous) cough increased, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis; (in PI subcutaneous) local infusion site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia; (in ITP) headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia; (in CIDP) headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia.

Please click here for the GAMMAKED Full Prescribing Information.