Takeda Announces U.S. Availability of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content1
− GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with Less Than or Equal to 2 µg/mL IgA in a 10% Solution is Now Available by Prescription for Intravenous or Subcutaneous Use in People Aged Two and Older with Primary Immunodeficiency1
Takeda ((TAK) today announced the U.S. availability of GAMMAGARD LIQUID™ ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, by prescription, approved as replacement therapy for people two years of age and older with primary immunodeficiency (PI). GAMMAGARD LIQUID ERC is a liquid immunoglobulin therapy that does not require reconstitution and has a low immunoglobulin A (IgA) content less than or equal to 2 µg/mL in a 10% solution to be administered intravenously or subcutaneously.1
"As the latest addition to our broad IG portfolio, GAMMAGARD LIQUID ERC underscores our ongoing dedication to providing differentiated therapeutic options to meet the varied needs of people with primary immunodeficiency, including those who require an option with low IgA content," said Uthra Sundaram, senior vice president and head of Takeda's U.S. Plasma-Derived Therapies Business Unit. "As a ready-to-use liquid, GAMMAGARD LIQUID ERC does not require reconstitution and can be administered intravenously or subcutaneously which may help ease the administration burden for patients and their health care providers."
GAMMAGARD LIQUID ERC shares the same state-of-the-art manufacturing process as the other liquid formulations in the Takeda IG portfolio, and features an Enhanced Removal Capability (ERC) to reduce the IgA content. It is available in two liquid vial sizes, 5 g/50 mL and 10 g/100 mL, and can be stored up to 24 months at room temperature (25°C; 77°F) or up to 36 months refrigerated (2-8 ℃; 36-46 °F).
Takeda continues to be the only manufacturer of immunoglobulin therapy with low IgA content less than or equal to 2 µg/mL in a 10% solution.1 In addition to GAMMAGARD LIQUID ERC, the current Takeda portfolio includes GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution, which is a lyophilized (freeze-dried) preparation that requires reconstitution.2
About GAMMAGARD LIQUID ERC
GAMMAGARD LIQUID ERC is a ready-to-use liquid immunoglobulin therapy with an IgA content of less than or equal to 2 µg/mL in a 10% solution to be administered intravenously or subcutaneously. It is indicated in the United States as replacement therapy for primary immunodeficiency (PI) in people two years of age and older.1
While GAMMAGARD LIQUID ERC is not indicated specifically for IgA sensitivity in people with primary immunodeficiency, it may be an appropriate option for them based on their physician's clinical judgment. GAMMAGARD LIQUID ERC is contraindicated in patients with a history of severe systemic hypersensitivity or anaphylactic reactions to the product. It also carries warnings and precautions regarding the potential for severe hypersensitivity reactions, including in patients who have previously tolerated immune globulin products. Despite containing low levels of IgA (≤2 µg/mL in a 10% solution), the risk of anaphylaxis remains.1
About GAMMAGARD S/D
GAMMAGARD S/D is a lyophilized (freeze-dried) immunoglobulin therapy with IgA content less than 1 µg/mL in a 5% solution for intravenous use only. It is indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older. GAMMAGARD S/D is also indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell CLL, for the treatment of adult patients with chronic immune thrombocytopenic purpura (ITP) to increase platelet count and to prevent and/or to control bleeding, and for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.2 Takeda has previously announced that GAMMAGARD S/D will be discontinued at the end of December 2027. However, GAMMAGARD S/D will remain available after December 2027—until inventory is depleted or expired.
About Primary Immunodeficiency (PI)
Primary immunodeficiency (PI) is a group of more than 550 rare and chronic disorders, where a part of the body's immune system is missing or does not function the way it should.3 These conditions result from genetic mutations, which are usually inherited.4 The symptoms of PI vary and can include frequent and/or persistent infections and unusual autoimmunity, often leading to prolonged periods of misdiagnosis despite consultations with multiple specialists.5 In the United States, PI affects about 1 in 1,200 people.6
Important Safety Information for GAMMAGARD LIQUID ERC and GAMMAGARD S/D
WARNING: THROMBOSIS
WARNING: RENAL DYSFUNCTION and ACUTE RENAL FAILURE
|
Contraindications
- GAMMAGARD LIQUID ERC and GAMMAGARD S/D are contraindicated in patients with a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD LIQUID ERC and GAMMAGARD S/D.
Warnings and Precautions
Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure have occurred in patients receiving GAMMAGARD S/D, including patients who tolerated previous treatments with GAMMAGARD S/D, even though it contains low levels of IgA. If a hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate treatment. IgA-deficient patients with antibodies to IgA are at greater risk of developing potentially severe hypersensitivity reactions, including anaphylaxis.
Renal Dysfunction/Failure: Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with IV use of IG products, especially those containing sucrose. Acute renal failure has been reported in association with GAMMAGARD S/D. Ensure patients are not volume depleted prior to infusion. In patients at risk due to pre-existing renal insufficiency or predisposition to acute renal failure, assess renal function before initiation and throughout treatment, and consider lower, more frequent dosing. If renal function deteriorates, consider discontinuation.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. It is critical to distinguish true hyponatremia from a pseudohyponatremia because certain treatments may lead to volume depletion, a further increase in serum viscosity, and a predisposition to thromboembolic events.
Thrombosis: May occur following treatment with IG products and in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Aseptic Meningitis Syndrome: May occur with use of IG products. Conduct a thorough neurological exam on patients exhibiting signs and symptoms, to rule out other causes of meningitis. Discontinuing IG treatment has resulted in remission within several days without sequelae. The syndrome usually begins within several hours to two days following IG treatment.
Hemolysis: GAMMAGARD LIQUID ERC and GAMMAGARD S/D contain blood group antibodies, which may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for signs and symptoms of hemolysis and delayed hemolytic anemia and, if present, perform appropriate confirmatory lab testing.
Transfusion-Related Acute Lung Injury: Non-cardiogenic pulmonary edema may occur with use of IG products. Monitor patients for pulmonary adverse reactions. If suspected, perform appropriate tests for presence of anti-neutrophil and anti-HLA antibodies in both product and patient serum. May be managed using oxygen therapy with adequate ventilatory support.
Transmittable Infectious Agents: Because GAMMAGARD LIQUID ERC and GAMMAGARD S/D are made from human plasma, they may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens) including the variant Creutzfeldt-Jakob disease (vCJD) agent, and the Creutzfeldt-Jakob disease agent.
Interference with Lab Tests: False positive serological test results and certain assay readings, with the potential for misleading interpretation, may occur as the result of passively transferred antibodies.
Alterations in serum sodium levels (i.e., acute hypernatremia, pseudohyponatremia) may occur with GAMMAGARD S/D. In patients on a low sodium diet, calculate the amount of sodium from GAMMAGARD S/D when determining dietary sodium intake.
Adverse Reactions
GAMMAGARD LIQUID ERC
No clinical studies have been conducted using GAMMAGARD LIQUID ERC. The safety of GAMMAGARD LIQUID ERC in patients with primary humoral immunodeficiency (PI) is supported by two clinical studies conducted on GAMMAGARD LIQUID.
IV administration: The most common adverse reactions observed in ≥5% of patients in study 1 were headache, fatigue, pyrexia, chills, nausea, pain in extremity, diarrhea, migraine, vomiting, dizziness, urticaria, cough, asthma, oropharyngeal pain, infusion site extravasation, arthralgia, rash, myalgia, pruritus, and cardiac murmur.
Subcutaneous administration: The most common adverse reactions observed in ≥5% of patients in study 2 were infusion site (local) event, headache, pyrexia, fatigue, heart rate increased, abdominal pain upper, vomiting, arthralgia, nausea, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous ulcer, migraine, oropharyngeal pain, and pain in extremity.
GAMMAGARD S/D
The most common adverse reactions observed in ≥5% of clinical trial patients during or within 48 hours of infusion were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis, and flushing.
The most serious adverse reactions reported postmarketing include renal failure, thrombotic events (myocardial infarction, cerebrovascular accidents, and pulmonary embolism), anaphylactic shock, aseptic meningitis, and hemolysis.
Drug Interactions
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).
For Full U.S. Prescribing Information for GAMMAGARD LIQUID ERC, please visit:
https://content.takeda.com/?contenttype=PI&product=GAM&language=ENG&country=USA&documentnumber=2
For Full U.S. Prescribing Information for GAMMAGARD S/D, please visit:
https://www.shirecontent.com/PI/PDFs/GGSD_USA_ENG.pdf
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
Important Notice
For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.
Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
References
1 GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution U.S. Prescribing Information.
2 GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution] U.S. Prescribing Information.
3 Immune Deficiency Foundation. Living With Primary Immunodeficiency. Accessed November 2025. Available at: https://primaryimmune.org/living-primary-immunodeficiency.
4 Centers for Disease Control and Prevention. About Primary Immunodeficiency (PI). Accessed November 2025. Available at: https://www.cdc.gov/primary-immunodeficiency/about/index.html.
5 Immune Deficiency Foundation. Understanding Primary Immunodeficiency. Accessed November 2025. Available at: https://primaryimmune.org/understanding-primary-immunodeficiency.
6 Kobrynski L, Powell RW, Bowen S. J Clin Immunol. 2014;34(8):954-961.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260114621969/en/
Media Contacts:
U.S. Media
Taryn Corbino
[email protected]