GAMMAGARD LIQUID

Product Characteristics

GAMMAGARD LIQUID has been part of the Takeda family of IG therapies since 2005¹

GAMMAGARD LIQUID was approved for PI in 2005, MMN in 2012, and CIDP in 2024.^1,2

CIDP=Chronic Inflammatory Demyelinating Polyneuropathy; MMN=Multifocal Motor Neuropathy; PI=Primary Immunodeficiency.

GAMMAGARD LIQUID is formulated with patient needs in mind¹

No added sodium

No added sugar

No preservatives

$No latex icon.$

No latex

Osmolality 240-300 mOsmol/kg, similar to physiologic levels

IgA average concentration of 37 µg/mL

pH range of 4.6-5.1

Glycine stabilized

Intravenous immune globulin (IVIG) products are not interchangeable^3-5

The final formulations differ among IVIGs, meaning they are not interchangeable.^3,5  When selecting an IVIG treatment, individual patient characteristics should be considered.^3,5

IVIG treatments are distinct plasma products with patient tolerance differing from one brand to another. IVIG treatments are not biologically equivalent, and caution should be used when changing products.^3,5

Patient conditions and risk factors to consider with IVIG administration

Patient risk factors (this is not an all-inclusive list)

Diabetes mellitus
Sepsis
Elderly
Paraproteinemia
Hypovolemia
Concomitant therapy with nephrotoxic drugs

IVIG risk factors^3,9

Sodium content	Sugar content	Osmolality	IgA	Volume load

Patient risk factors (this is not an all-inclusive list)

Thromboembolic risk factors
Hypertension
Coronary artery disease
Hyperlipidemia
Heart failure
Cardiovascular risk factors

IVIG risk factors^3,9

Sodium content	Sugar content	Osmolality	IgA	Volume load

Patient risk factors (this is not an all-inclusive list)

Type 1
Type 2

IVIG risk factors^3,9

Sodium content	Sugar content	Osmolality	IgA	Volume load

Patient risk factors (this is not an all-inclusive list)

Generally considered as >65 years of age

IVIG risk factors^3,9

Sodium content	Sugar content	Osmolality	IgA	Volume load

Patient risk factors (this is not an all-inclusive list)

IgA-deficient patients with antibodies to IgA and a history of hypersensitivity
There is no established threshold with respect to IgA below which reactions will not occur

IVIG risk factors^3,9

Sodium content	Sugar content	Osmolality	IgA	Volume load

Patient risk factors (this is not an all-inclusive list)

Hyperviscosity risk factors
Pulmonary edema
Cardiac impairment
Hypertension
Renal impairment
Elderly

IVIG risk factors^3,9

Sodium content	Sugar content	Osmolality	IgA	Volume load

Review the product characteristics for 12 IVIG treatments for PI

Download to save or print for easy reference. Please note, this chart provides product characteristics and does not imply clinical outcomes.

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Get information regarding GAMMAGARD LIQUID

Vial Sizes & Storage

References:

GAMMAGARD LIQUID. Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.
Baxter announces FDA approval for GAMMAGARD LIQUID as a treatment for multifocal motor neuropathy. News release. June 25, 2012. Accessed April 18, 2024. https://investor.baxter.com/investors/events-and-news/news/press-release-details/2012/Baxter-Announces-FDA-Approval-for-GAMMAGARD-LIQUID-as-a-Treatment-for-Multifocal-Motor-Neuropathy/default.aspx
Gelfand EW. Differences between IVIG products: impact on clinical outcome. Int Immunopharmacol. 2006;6(4):592-599. doi:10.1016/j.intimp.2005.11.003
Ballow M. Safety of IVIG therapy and infusion-related adverse events. Immunol Res. 2007;38(1-3):122-132.
Eight guiding principles for effective use of IVIG for patients with primary immunodeficiency. American Academy of Allergy, Asthma & Immunology. December 2011. Accessed June 2, 2021. https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF%20Documents/Practice%20Resources/IVIG-guiding-principles.pdf
Gurcan HM, Keskin DB, Ahmed AR. Information for healthcare providers on general features of IGIV with emphasis on differences between commercially available products. Autoimmun Rev. 2010;9(8):553-559.
Ochs HD, Siegel J. Stabilizers used in intravenous immune globulin products: a comparative review. Pharm Pract News. 2010. Accessed August 26, 2019. http://www.pharmacypracticenews.com/download/SR1019_Stabl_IVIG_WM.pdf
Important drug warning: potential risk of acute renal failure reported to be associated with administration of Immune Globulin Intravenous (Human). US Food and Drug Administration. Accessed August 26, 2019. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm105901.htm
Siegel J. Tailoring IVIG therapy to the individual patient: considerations for pharmacy practice. Pharm Pract News. 2007. Accessed June 2, 2021. http://pharmacypracticenews.com/download/07015SR-FINALWM.pdf
Brown HC, Ballas ZK. Acute thromboembolic events associated with intravenous immunoglobulin infusion in antibody-deficient patients. J Allergy Clin Immunol. 2003;112(4):797-799.
Lemm G. Composition and properties of IVIg preparations that affect tolerability and therapeutic efficacy. Neurology. 2002;59(12 suppl6):S28-S32.
Paran D, Herishanu Y, Elkayam O, Shopin L, Ben-Ami R. Venous and arterial thrombosis following administration of intravenous immunoglobulins. Blood Coagul Fibrinolysis. 2005;16(5):313-318.
Cheng MJ, Christmas C. Special considerations with the use of intravenous immunoglobulin in older persons. Drugs Aging. 2011;28(9):729-736.

IMPORTANT SAFETY INFORMATION Including BOXED WARNINGS for Thrombosis, Renal Dysfunction, and Acute Renal Failure

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. 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.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. 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. GAMMAGARD LIQUID does not contain sucrose.
For patients at risk of thrombosis, administer GAMMAGARD LIQUID 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 of hyperviscosity.

INDICATIONS

GAMMAGARD LIQUID is indicated as a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older, as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN), and as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

LIMITATIONS OF USE (CIDP): GAMMAGARD LIQUID has not been studied in immunoglobulin-naïve patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy.

GAMMAGARD LIQUID for PI is for intravenous or subcutaneous use.

GAMMAGARD LIQUID for MMN and CIDP is for intravenous use only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. 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.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. 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. GAMMAGARD LIQUID does not contain sucrose.
For patients at risk of thrombosis, administer GAMMAGARD LIQUID 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 of hyperviscosity.

CONTRAINDICATIONS

History of anaphylactic or severe systemic hypersensitivity reactions to human IG.
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. 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 dysfunction/failure has been reported in association with infusions of GAMMAGARD LIQUID. 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 use the minimum infusion rate practicable for IV administration. 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: Has been reported with use of IG and may occur more frequently in females. 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.

Hemolysis: GAMMAGARD LIQUID contains 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 has been reported with IV-administered IG, including GAMMAGARD LIQUID. 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 is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID.

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.

ADVERSE REACTIONS

The serious adverse reactions observed in clinical studies in PI was aseptic meningitis, and in MMN were pulmonary embolism and blurred vision.

The most common adverse reactions observed in ≥5% of subjects were:

IV administration for PI: Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.

Subcutaneous administration for PI: Infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.

IV administration for MMN: Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.

IV administration for CIDP: Headache, pyrexia, anemia, leukopenia, neutropenia, illness, blood creatinine increased, dizziness, migraine, somnolence, tremor, nasal dryness, abdominal pain upper, vomiting, chills, nasopharyngitis, and pain in extremity.

DRUG INTERACTIONS

Passive transfer of antibodies may transiently interfere with immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

Please click for Full Prescribing Information.

INDICATIONS

GAMMAGARD LIQUID is indicated as a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older, as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN), and as a therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

LIMITATIONS OF USE (CIDP): GAMMAGARD LIQUID has not been studied in immunoglobulin-naïve patients with CIDP. GAMMAGARD LIQUID maintenance therapy in CIDP has not been studied for periods longer than 6 months. After responding during an initial treatment period, not all patients require indefinite maintenance therapy with GAMMAGARD LIQUID in order to remain free of CIDP symptoms. Individualize the duration of any treatment beyond 6 months based upon the patient’s response and demonstrated need for continued therapy.

GAMMAGARD LIQUID for PI is for intravenous or subcutaneous use.

GAMMAGARD LIQUID for MMN and CIDP is for intravenous use only.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin (IG) products, including GAMMAGARD LIQUID. 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.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. 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. GAMMAGARD LIQUID does not contain sucrose.
For patients at risk of thrombosis, administer GAMMAGARD LIQUID 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 of hyperviscosity.

CONTRAINDICATIONS

History of anaphylactic or severe systemic hypersensitivity reactions to human IG.
IgA-deficient patients with antibodies to IgA and a history of hypersensitivity to human IG. Anaphylaxis has been reported with intravenous (IV) use of GAMMAGARD LIQUID.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with human IG. 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 dysfunction/failure has been reported in association with infusions of GAMMAGARD LIQUID. 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 use the minimum infusion rate practicable for IV administration. 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: Has been reported with use of IG and may occur more frequently in females. 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.

Hemolysis: GAMMAGARD LIQUID contains 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 has been reported with IV-administered IG, including GAMMAGARD LIQUID. 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 is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, other pathogens). No confirmed cases of viral transmission or variant Creutzfeldt-Jakob disease (vCJD) have been associated with GAMMAGARD LIQUID.

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.

ADVERSE REACTIONS

The serious adverse reactions observed in clinical studies in PI was aseptic meningitis, and in MMN were pulmonary embolism and blurred vision.

The most common adverse reactions observed in ≥5% of subjects were:

IV administration for PI: Headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, and cardiac murmur.

Subcutaneous administration for PI: Infusion site (local) event (rash, erythema, edema, hemorrhage, and irritation), headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis, migraine, oropharyngeal pain, and pain in extremity.

IV administration for MMN: Headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity.

IV administration for CIDP: Headache, pyrexia, anemia, leukopenia, neutropenia, illness, blood creatinine increased, dizziness, migraine, somnolence, tremor, nasal dryness, abdominal pain upper, vomiting, chills, nasopharyngitis, and pain in extremity.

DRUG INTERACTIONS

Passive transfer of antibodies may transiently interfere with immune responses to live attenuated virus vaccines (e.g., measles, mumps, rubella, and varicella).

Please click for Full Prescribing Information.