ICE Study Results

Patients receiving GAMMAKED in
the ICE study experienced:


1. Lower probability of relapse1,2:

> The probability of relapse for patients receiving
   GAMMAKED was 13% vs 45% for those receiving
   placebo
> Patients receiving GAMMAKED had a longer time to
   relapse vs patients receiving placebo
> Withdrawal of therapy (re-randomization to placebo)
   increased the risk of CIDP relapse

 

 

 

 

 

2. Improved physical functioning3:

Long-term therapy with GAMMAKED improved physical functioning in patients with CIDP. 

ICE study participants were assessed using the Short Form-36 (SF-36) health survey. SF-36 physical component domain scores were recorded at screening and again at the end of each period.

> Significant improvements from baseline were
   observed in SF-36 domain scores for:
    Physical functioning (such as the ability to
       walk or climb stairs)4
    Role-physical (activities of daily living,
       including work)4

 

3. Continued improvement over the full 24 weeks of therapy5: 

> Among CIDP patients who responded* to GAMMAKED:
     – 47% initially responded by week 3
      53% initially responded by week 6

Cumulative number of responders reaching maximum improvement in INCAT scores

> The number of patients reaching 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
   full therapeutic benefit, such as the abilities to walk or dress unaided6

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

† An individual patient’s maximal INCAT score over the course of the ICE study

 

Adverse reactions in CIDP2

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


References: 1. Hughes RAC, Donofrio P, Bril V, et al, on behalf of the ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study); a randomized placebo-controlled trial. Lancet Neurol. 2008;7:136-44. 2. GAMMAKED [prescribing information]. Fort Lee, NJ: Kedrion Biopharma Inc.; 2016. 3. 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. 4. McHorney CA, Ware JE, 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;1:40-66. 5. Latov N, Deng C, Dalakas MC, et al, on behalf of the ICE Study Group. Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy. Arch Neurol. 2010;67(7):802-807. 6. 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 indicated for the treatment of primary humoral immunodeficiency disease (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

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.

Aseptic Meningitis Syndrome (AMS) has been reported with GAMMAKED and other IGIV treatments, especially with high doses or rapid infusion.

Hemolysis, either intravascular or due to enhanced red blood cell (RBC) sequestration, can develop subsequent to GAMMAKED treatments. Risk factors include high doses and non-O blood group. Monitor patients for hemolysis and hemolytic anemia.

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 or CIDP. 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 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, influenza, fatigue, arthralgia and pyrexia with subcutaneous use (in PI); and headache, vomiting, fever, nausea, back pain, and rash (in ITP).

Please click here for the GAMMAKED Full Prescribing Information.