GAMMAKED Efficacy and Safety in CIDP Was Demonstrated in the Pivotal ICE Study1

The ICE Study was the first IVIG trial to demonstrate long-term efficacy and safety of GAMMAKED in CIDP

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  • GAMMAKED improved physical functioning, therapeutic response, and relapse rates in CIDP
Info graphic showing the ICE Study design over 48 weeks
Gamunex®-C was the brand name of the product used in the ICE Study. Gamunex-C and GAMMAKED are equivalent.

GAMMAKED dosing in the ICE Study

  • Loading dose (Efficacy Period): 2 g/kg over 2–4 days
    • 79% of loading dose infusions in the GAMMAKED arm were given over 2 days
  • Maintenance dose (Extension Phase): 1 g/kg over 1–2 days every 3 weeks
    • 80% of maintenance dose infusions were given over 1 day
    • 96% of maintenance dose infusions were given within 5 hours

Patient Resources

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More about GAMMAKED and the ICE Study:

Physical Functioning
Therapeutic Response
Probability of Relapse
Adverse Event Results

GAMMAKED Continuously Improved Physical Functioning Through the First 24 Weeks of the ICE Study1

Adjusted INCAT disability scores. GAMMAKED significantly increased the percentage of responders from baseline through Week 24 compared to placebo (Primary endpoint)

A “responder” was defined as a patient with improvement of ≥1 point in adjusted INCAT disability score that was maintained through Week 24
Adjusted INCAT disability scores bar graph

Grip strength. GAMMAKED significantly improved grip strength from baseline to Week 24 in both dominant and non-dominant hands compared to placebo

Grip strength from baseline bar graph

In a Post Hoc Analysis of the ICE Study, the Number of Patients Reaching Maximal Improvement Continued to Increase for 24 Weeks3

Cumulative number of responders reaching maximum improvement 
in adjusted INCAT disability scores*

Cumulative number of responders reaching maximum improvement in adjusted INCAT disability scores graph
*From Latov N, et al., post hoc analysis of data extracted from the ICE trial.8
  • Maximum improvement was defined as an individual patient’s maximal INCAT disability score over the course of the ICE Study
  • Data suggest that treatment with two courses of GAMMAKED administered 3 weeks apart may be required for initial improvement, and continued maintenance therapy may be necessary to achieve a maximal therapeutic response

GAMMAKED Administered Over 48 Weeks Lowered Probability of Relapse and Extended Time to Relapse in the ICE Study1

Probability of CIDP relapse
was lower for GAMMAKED

Withdrawal of therapy (re-randomization to placebo) increased risk of CIDP relapse
Probability of CIDP relapse bar graph highlighting GAMMAKED being lower

Time to CIDP relapse was longer for patients who continued to receive GAMMAKED

Data are from patients who were adjusted-INCAT responders to GAMMAKED during the Efficacy Period and who entered the Extension Phase
Time to CIDP relapse graphic highlighting GAMMAKED being longer

GAMMAKED Was Well Tolerated in the ICE Study1

Adverse event (AE) results in the ICE Study were consistent with those reported in other IVIG studies

AEs reported in ≥5% of patients within each treatment group, irrespective of causality

GAMMAKED (n=113) PLACEBO (n=95)
AE Patients, n (%) Frequency*, % Patients, n(%) Frequency*, %
Headache 36 (32) 5.2 8 (8) 2.6
Pyrexia 15 (13) 2.5 0 0
Hypertension 10 (9) 1.8 4 (4) 1.0
Asthenia 9 (8) 0.9 3 (3) 0.7
Chills 9 (8) 0.9 0 0
Back pain 9 (8) 0.9 3 (3) 0.5
Rash 8 (7) 1.2 1 (1) 0.2
Arthralgia 8 (7) 1 1 (1) 0.2
Nausea 7 (6) 0.8 3 (3) 0.5
Dizziness 7 (6) 0.6 1 (1) 0.2
Influenza 6 (5) 0.5 2 (2) 0.3
*% of AEs in the safety population divided by total number of infusions in group (1096 for GAMMAKED and 575 for placebo).
  • Frequencies of AEs per infusion were low with GAMMAKED and did not differ greatly from placebo
  • Incidence of serious AEs in the GAMMAKED group was also low and similar to placebo, even with the long-term administration (every 3 weeks for up to 48 weeks) of high dose GAMMAKED (1 g/kg)
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GAMMAKED

CI, confidence interval; CIDP, chronic inflammatory demyelinating polyneuropathy; ICE, IGIV-C CIDP Efficacy; IGIV-C, 10% caprylate-chromatography purified immune globulin intravenous; INCAT, Inflammatory Neuropathy Cause and Treatment; IVIG, intravenous immune globulin.

*Randomized, double-blind, placebo-controlled, response-conditional crossover trial with two separately randomized periods; the 24-week Extension Phase was a re-randomization to GAMMAKED vs placebo.

†INCAT is a validated, 10-point assessment used to evaluate functional disability in demyelinating polyneuropathy; assesses patient’s ability to walk (scale of 0–5) and to perform certain arm functions (scale of 0–5). Overall INCAT disability score is the sum of arm and leg scores. Adjusted INCAT score excludes upper limb function changes from 0 (normal) to 1 (minor symptoms) or from 1 to 0.1,2

References: 1. Hughes RAC, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE Study): a randomised placebo-controlled trial. Lancet Neurol. 2008;7:136-144. 2. Hughes R, et al. Inflammatory Neuropathy Cause and Treatment (INCAT) Group. Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy. Ann Neurol. 2001;50(2):195-201. 3. Latov N, 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.

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Indications and Usage

GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is indicated 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.

Important Safety Information

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.

Contraindications

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.

Warnings and Precautions

Hypersensitivity: Severe hypersensitivity reactions may occur with IGIV products, including GAMMAKED. In case of hypersensitivity, discontinue GAMMAKED infusion immediately and institute appropriate treatment. GAMMAKED contains trace amounts of IgA (average 46 micrograms/mL). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity reaction.

Renal Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur upon use of IGIV products, especially those containing sucrose. GAMMAKED does not contain sucrose. Ensure that patients are not volume depleted prior to the initiation of the infusion of GAMMAKED. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk for developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN)/serum creatinine, prior to the initial infusion of GAMMAKED and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of GAMMAKED. For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency or risk factors for renal insufficiency, administer GAMMAKED at the minimum infusion rate practicable [less than 8 mg/kg/min (0.08 mL/kg/min)].

Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy, including GAMMAKED. It is clinically critical to distinguish true hyponatremia from a pseudohyponatremia that is associated with concomitant decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a possible predisposition to thrombosis.

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

Hemolysis: 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.

Transfusion-related Acute Lung Injury (TRALI): 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]).

Volume Overload: 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.

Transmission of Infectious Agents: 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. Hematoma Formation: 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.

Interference with Laboratory Tests: 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.

Adverse Reactions

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, erythema, 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 Full Prescribing Information for complete prescribing details including Boxed Warning, contraindications and dosing and administration information.

IMPORTANT SAFETY INFORMATION