GAMMAGARD Liquid Immune Globulin Infusion (Human) 100 mg/mL Injection, Solution
🆔 Identity & classification
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🩺 Clinical
- Think of it as a collection of protective proteins — called antibodies — that healthy donors have built up against many different germs. If your immune system can't make enough of...
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🧪 Inactive Ingredients / Excipients
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UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $129.34 | $1,293.37 / 10 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1569 | $49.303 / J1569 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| GAMMAGARD Liquid ERC 100 mg/mL 00944-2705-10 | Takeda | 1 vial | — | — | FDA listed | — |
| GAMMAGARD Liquid 100 mg/mLthis 00944-2700-02 | Takeda | 1 bottle | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00944-2700-02 You're viewing this | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-02) / 10 mL in 1 BOTTLE, GLASS (0944-2700-08) | 2005-04-27 | Active |
| 00944-2700-03 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-03) / 25 mL in 1 BOTTLE, GLASS (0944-2700-09) | 2005-04-27 | Active |
| 00944-2700-04 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-04) / 50 mL in 1 BOTTLE, GLASS (0944-2700-10) | 2005-04-27 | Active |
| 00944-2700-05 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-05) / 100 mL in 1 BOTTLE, GLASS (0944-2700-11) | 2005-04-27 | Active |
| 00944-2700-06 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-06) / 200 mL in 1 BOTTLE, GLASS (0944-2700-12) | 2005-04-27 | Active |
| 00944-2700-07 | 1 BOTTLE, GLASS in 1 CARTON (0944-2700-07) / 300 mL in 1 BOTTLE, GLASS (0944-2700-13) | 2005-04-27 | Active |
This pack accounts for about 6.5% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
WARNING: ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), 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 renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum infusion rate practicable. Warning: RENAL DYSFUNCTION & ACUTE RENAL FAILURE See full prescribing information for complete boxed warning Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.
Renal dysfunction and acute failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum rate of infusion practicable.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies 1,2 . GAMMAGARD LIQUID is an immune globulin infusion (human) indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dose Initial Infusion rate Maintenance Infusion rate Intravenous Administration: • 300 to 600 mg/kg every 3 to 4 weeks based on clinical response 0.5 mL/kg/hr (0.8 mg/kg/min) for 30 minutes Increase every 30 minutes (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min) Subcutaneous Administration: • Initial Dose is 1.37 × previous intravenous dose divided by # of weeks between intravenous doses. • Maintenance dose is based on clinical response and target IgG trough level (2.2). 40 kg BW and greater: 30 mL/site at 20 mL/hr/site Under 40 kg BW: 20 mL/site at 15 mL/hr/site 40 kg BW and greater: 30 mL/site at 20 to 30 mL/hr/site.
Under 40 kg BW: 20 mL/site at 15 to 20 mL/hr/site Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue GAMMAGARD LIQUID if renal function deteriorates. ( 2.3 , 5.2 ) For patients at risk of renal dysfunction or thrombotic events, administer GAMMAGARD LIQUID at the minimum infusion rate practicable. ( 2.3 , 5.2 , 5.4 ).
2.1Dosage Table 1. Dosage and Administration Dose Initial Infusion rate Maintenance Infusion rate Intravenous Administration: • 300 to 600 mg/kg every 3 to 4 weeks based on clinical response 0.5 mL/kg/hr (0.8 mg/kg/min) for 30 minutes Increase every 30 minutes (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min) Subcutaneous Administration: • Initial Dose is 1.37 × previous intravenous dose divided by # of weeks between intravenous doses. • Maintenance dose is based on clinical response and target IgG trough level (2.2). 40 kg BW and greater: 30 mL/site at 20 mL/hr/site.
Under 40 kg BW: 20 mL/site at 15 mL/hr/site 40 kg BW and greater: 30 mL/site at 20 to 30 mL/hr/site. Under 40 kg BW: 20 mL/site at 15 to 20 mL/hr/site Adjust dose according to IgG levels and clinical response , as the frequency and dose of immune globulin may vary from patient to patient. No randomized controlled clinical trials are available to determine an optimum trough serum IgG level for intravenous treatment.
If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable. Prior to switching from intravenous to subcutaneous treatment, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments. Start the initial subcutaneous dose approximately one week after the last intravenous infusion.
Dose Adjustments for Subcutaneous Administration Based on the results of clinical studies, the expected increase in serum IgG trough level while on weekly subcutaneous treatment, at the dose adjusted to provide a comparable AUC, is projected to be approximately 281 mg/dL higher than the last trough level during prior stable intravenous treatment. To calculate the target trough IgG level for subcutaneous treatment, add 281 mg/dL to the IgG trough level obtained after the last intravenous treatment. To guide dose adjustment, calculate the difference between the patient’s target serum IgG trough level and the IgG trough level during subcutaneous treatment.
Find this difference in the columns of Table 2 and the corresponding amount (in mL) by which to increase (or decrease) the weekly dose based on the patient's body weight. If the difference between measured and target trough levels is less than 100 mg/dL then no adjustment is necessary. However, the patient's clinical response should be the primary consideration in dose adjustment .
Table 2. Change in Weekly Dose of GAMMAGARD LIQUID for Intended IgG Trough Level Adjustment Derived using a linear approximation to the nomogram method with a slope of 5.3 kg/dL Difference between Measured and Target IgG Trough Levels Body Weight 100 mg/dL 200 mg/dL 300 mg/dL 400 mg/dL 10 kg 2 mL 4 mL 6 mL 8 mL 20 kg 4 mL 8 mL 11 mL 15 mL 30 kg 6 mL 11 mL 17 mL 23 mL 40 kg 8 mL 15 mL 23 mL 30 mL 50 kg 9 mL 19 mL 28 mL 38 mL 60 kg 11 mL 23 mL 34 mL 45 mL 70 kg 13 mL 26 mL 40 mL 53 mL 80 kg 15 mL 30 mL 45 mL 60 mL 90 kg 17 mL 34 mL 51 mL 68 mL 100 kg…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS GAMMAGARD LIQUID is an aqueous solution containing 10% IgG (100 mg/mL). Aqueous solution containing 10% IgG (100 mg/mL) ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human) ( 4 ). IgA deficient patients with antibodies against IgA and a history of hypersensitivity ( 4 ).
4.1Hypersensitivity Reaction to Immune Globulins GAMMAGARD LIQUID is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin.
4.2IgA Sensitive Patients with History of Hypersensitivity Reactions GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with the intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous administration ( 5.1 ).
4.1Hypersensitivity Reaction to Immune Globulins GAMMAGARD LIQUID is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immune globulin.
4.2IgA Sensitive Patients with History of Hypersensitivity Reactions GAMMAGARD LIQUID is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Anaphylaxis has been reported with the intravenous use of GAMMAGARD LIQUID and is theoretically possible following subcutaneous administration ( 5.1 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS IgA deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reaction. ( 5.1 ) Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. ( 5.2 ) Hyperproteinemia, increased serum viscosity and hyponatremia may occur.
( 5.3 ) Thrombotic events may occur. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk for hyperviscosity. ( 5.4 ) Aseptic Meningitis Syndrome (AMS) may occur.
( 5.5 ) Hemolytic anemia can develop. Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. ( 5.6 ) Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury, TRALI).
( 5.7 ) Product is made from human plasma and may contain infectious agents, e.g., viruses and theoretically, Creutzfeldt-Jacob disease (CJD) agent. ( 5.8 )
5.1Hypersensitivity Severe hypersensitivity reactions may occur, even in patients who had tolerated previous treatment with human normal immune globulin. In case of hypersensitivity, discontinue GAMMAGARD LIQUID infusion immediately and institute appropriate treatment. GAMMAGARD LIQUID contains trace amount of IgA (average concentration of 37μg/mL).
Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. GAMMAGARD LIQUID is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction ( see CONTRAINDICATIONS [4 ] )
5.2Renal Dysfunction/Failure Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis and death may occur upon use of IGIV treatment, especially those containing sucrose 3 . Acute renal dysfunction/failure has been reported in association with infusions of GAMMAGARD LIQUID. Assure that patients are not volume depleted prior to the initiation of infusion of GAMMAGARD LIQUID.
In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure (such as diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, etc.), administer GAMMAGARD LIQUID intravenously at the minimum rate of infusion practicable (not exceeding 3.3 mg IgG/kg/min (< 2 mL/kg/hr) (see DOSAGE AND ADMINISTRATION [ 2.3 ] ). Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk for developing acute renal failure.
Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of GAMMAGARD LIQUID and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation of GAMMAGARD LIQUID (see DOSAGE AND ADMINISTRATION[ 2 ]).
5.3Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia Hyperproteinemia, increased serum viscosity and hyponatremia may occur in patients receiving GAMMAGARD LIQUID. It is critical to distinguish true hyponatremia from a pseudohyponatremia that is temporally or causally related to hyperproteinemia 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 predisposition to thromboembolic events 4 .
5.4Thrombotic Events Thrombotic events, including myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism, have been reported in association with intravenous use of GAMMAGARD LIQUID ( see ADVERSE REACTIONS [ 6 ] ). Thrombotic events have also been reported with subcutaneous administration of immune globulin. Patients at risk for thrombotic events include those with a hi…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Intravenous : The most serious adverse reaction seen during intravenous treatment in the clinical trials was two episodes of aseptic meningitis in one subject. The most common adverse reactions (observed in ≥5% of subjects) were headache, pyrexia, fatigue, rigors, nausea, chills, dizziness, vomiting, migraine headache, pain in extremity, urticaria, cough, pruritus, rash and tachycardia. Subcutaneous : No serious adverse reactions were observed during the clinical trial of subcutaneous treatment.
The most common adverse reactions during subcutaneous treatment (observed in ≥5% of subjects) were local infusion site reactions. The most common systemic reactions were headache, fever, fatigue, increased heart rate, increased systolic blood pressure, and upper abdominal pain. The most common adverse reactions observed in ≥5% of patients were ( 6.1 ): Intravenous Administration: headache, pyrexia, fatigue, rigors, nausea, chills, dizziness, vomiting, migraine headache, pain in extremity, urticaria, cough, pruritus, rash and tachycardia.
Two serious adverse reactions occurred in the clinical trial with GAMMAGARD LIQUID: two episodes of aseptic meningitis in a single patient ( 6.1 ). Subcutaneous Administration - local infusion site reactions (e.g., swelling, redness, pain), headache, fever, fatigue, increased heart rate, increased systolic blood pressure, and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice . Intravenous Administration The safety of GAMMAGARD LIQUID intravenous infusion was evaluated in 61 subjects 6 . Of all adverse experiences, 15 events in 8 subjects were serious with two episodes of aseptic meningitis in one patient deemed to be possibly related to the infusion of GAMMAGARD LIQUID.
Among the 896 non-serious adverse experiences, 258 were judged by the investigator to be possibly or probably related to the infusion of GAMMAGARD LIQUID. Of these, 136 were rated as mild (transient discomfort that resolves spontaneously or with minimal intervention), 106 were rated as moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 16 were rated as severe (marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae).
All of the severe non-serious adverse experiences were transient, did not lead to hospitalization, and resolved without complication. One subject withdrew from the study due to a non-serious adverse experience (papular rash). Temporally associated adverse events are those occurring during or within 72 hours of completion of an infusion, regardless of causality.
Of the 345 temporally related adverse events, those occurring in > 5% of subjects are shown in Table 5 Only one event, headache, occurred in association with more than 5% of infusions. Table 5. Adverse Events Excluding Infections , Regardless of Causality, that Occurred within 72 Hours of Infusion Event By Infusion N (%) By Subject N (%) Headache 57 (7%) 22(36%) Fever 19(2%) 13(21%) Fatigue 18(2%) 10(16%) Vomiting 10(1%) 9(15%) Chills 14(2%) 8(23%) Infusion site events 8(1%) 8(13%) Nausea 9(1%) 6(10%) Dizziness 7(1%) 6(10%) Pain in Extremity 7(1%) 5(8%) Diarrhea 7(1%) 5(8%) Cough 5(1%) 5(8%) Pruritus 5(1%) 4(7%) Pharyngeal Pain 5(1%) 4(7%) Table 6 lists the related adverse events occurring in 5% or more of the 61 subjects from the pivotal multicenter clinical study.
Adverse drug reactions (ADR's) are those adverse events that were deemed by the investigators as causal…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella and varicella for up to 6 months and for a year or more to measles (rubeola). Inform the immunizing physician of recent therapy with GAMMAGARD LIQUID so that appropriate precautions can be taken ( see PATIENT COUNSELING INFORMATION [ 17 ] ). Passive transfer of antibodies may transiently interfere with the immune responses to live virus vaccines, such as measles, mumps, rubella, and varicella.( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Use only if clearly indicated ( 8.1 ) Geriatric: In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose, and infuse GAMMAGARD LIQUID at the minimum infusion rate practicable. ( 8.5 )
8.1Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with GAMMAGARD LIQUID. It is also not known whether GAMMAGARD LIQUID can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. GAMMAGARD LIQUID should be given to a pregnant woman only if clearly indicated.
8.3Nursing Mothers It is not known whether GAMMAGARD LIQUID is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GAMMAGARD LIQUID is administered to a nursing woman.
8.4Pediatric Use The safety and effectiveness of GAMMAGARD LIQUID have been established in the age groups 2 to 16. Use of GAMMAGARD LIQUID in these age groups is supported by evidence from adequate and well-controlled studies of GAMMAGARD LIQUID including pediatric subjects. GAMMAGARD LIQUID administered intravenously was evaluated in 15 pediatric subjects with PI (7 were 2 to <12 years old and 8 were 12 to <16) in a multicenter clinical study.
GAMMAGARD LIQUID administered subcutaneously was evaluated in 18 pediatric subjects with PI (14 were 2 to <12 years old and 4 were 12 to <16) in another multicenter clinical study (see CLINICAL STUDIES [ 14 ]). There were no differences in the safety and efficacy profiles as compared with adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Safety and efficacy of GAMMAGARD LIQUID in pediatric patients below the age of 2 have not been established.
8.5Geriatric Use Limited information is available for the geriatric use of GAMMAGARD LIQUID. GAMMAGARD LIQUID administered intravenously and subcutaneously was evaluated in two studies with a total of 8 subjects over the age of 65 years. No overall differences in safety or efficacy were observed for this group.
Caution should be exercised in administering GAMMAGARD LIQUID to patients who are at an increased risk for developing renal failure or thrombotic events. Do not exceed the recommended dose, and infuse GAMMAGARD LIQUID at the minimum intravenous infusion rate practicable (See BOXED WARNING, WARNINGS AND PRECAUTIONS [ 5.2 , 5.4 ] and DOSAGE AND ADMINISTRATION [ 2.3 ] ).
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with GAMMAGARD LIQUID. It is also not known whether GAMMAGARD LIQUID can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. GAMMAGARD LIQUID should be given to a pregnant woman only if clearly indicated.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of GAMMAGARD LIQUID have been established in the age groups 2 to 16. Use of GAMMAGARD LIQUID in these age groups is supported by evidence from adequate and well-controlled studies of GAMMAGARD LIQUID including pediatric subjects. GAMMAGARD LIQUID administered intravenously was evaluated in 15 pediatric subjects with PI (7 were 2 to <12 years old and 8 were 12 to <16) in a multicenter clinical study.
GAMMAGARD LIQUID administered subcutaneously was evaluated in 18 pediatric subjects with PI (14 were 2 to <12 years old and 4 were 12 to <16) in another multicenter clinical study (see CLINICAL STUDIES [ 14 ]). There were no differences in the safety and efficacy profiles as compared with adult subjects. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels.
Safety and efficacy of GAMMAGARD LIQUID in pediatric patients below the age of 2 have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Limited information is available for the geriatric use of GAMMAGARD LIQUID. GAMMAGARD LIQUID administered intravenously and subcutaneously was evaluated in two studies with a total of 8 subjects over the age of 65 years. No overall differences in safety or efficacy were observed for this group.
Caution should be exercised in administering GAMMAGARD LIQUID to patients who are at an increased risk for developing renal failure or thrombotic events. Do not exceed the recommended dose, and infuse GAMMAGARD LIQUID at the minimum intravenous infusion rate practicable (See BOXED WARNING, WARNINGS AND PRECAUTIONS [ 5.2 , 5.4 ] and DOSAGE AND ADMINISTRATION [ 2.3 ] ).
🆘 Overdosage ▾
10 OVERDOSAGE With intravenous administration, overdose of GAMMAGARD LIQUID may lead to fluid overload and hyperviscosity. Patients at risk of complications of fluid overload and hyperviscosity include elderly patients and those with cardiac or renal impairment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action GAMMAGARD LIQUID supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. GAMMAGARD LIQUID also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanisms of action of IgG in GAMMAGARD LIQUID have not been fully elucidated.
12.3Pharmacokinetics Intravenous Administration Following intravenous infusion, IGIV products show a biphasic decay curve. The initial (α) phase is characterized by an immediate post-infusion peak in serum IgG and is followed by rapid decay due to equilibration between the plasma and extravascular fluid compartments. The second (β) phase is characterized by a slower and constant rate of decay.
The commonly cited “normal” half-life of 18 to 25 days is based on studies in which tiny quantities of radiolabeled IgG are injected into healthy individuals. When radiolabeled IgG was injected into patients with hypogammaglobulinemia or agammaglobulinemia, highly variable half-lives ranging from 12 to 40 days were observed. In other radiolabeled studies, high serum concentrations of IgG, and hypermetabolism associated with fever and infection, have been seen to coincide with a shortened half-life of IgG.
In contrast, however, pharmacokinetic studies in immunodeficient patients are based on the decline of IgG concentrations following infusions of large quantities of immune globulin. In such trials, investigators have reported uniformly prolonged half-lives of 26 to 35 days. Pharmacokinetic parameters for GAMMAGARD LIQUID were determined from total IgG levels following the fourth infusion in 61 subjects with primary humoral immunodeficiency treated intravenously with the product every 3 or 4 weeks according to the regimen used prior to entering the study.
Of these, 57 had sufficient pharmacokinetic data to be included in the dataset. The median weight-adjusted dose per subject was 455 mg/kg/4 weeks with a range of 262 to 710. Pharmacokinetic parameters are presented in Table 11 .
Table 11. Summary of Intravenous Pharmacokinetic Parameters in 57 Subjects Parameter Median 95% Confidence Interval Dose of IgG (mg/kg/4 weeks) 455 Range: 262-710 Elimination Half-Life ( T ½ days) 35 (31, 42) AUC 0-21d (mg·days/dL) 29139 (27494, 30490) C max (Peak, mg/dL) 2050 (1980, 2200) C min (Trough, mg/dL) 1030 (939, 1110) Incremental recovery (mg/dL)/(mg/kg) 2.3 (2.2, 2.6) Abbreviations: AUC = area under the curve; C max = maximum concentration; C min = minimum concentration. Median IgG trough levels were maintained between 960 to 1120 mg/dL.
These dosing regimens maintained serum trough IgG levels generally considered adequate to prevent bacterial infections. The elimination half-life of GAMMAGARD LIQUID of 35 days was similar to the half-lives reported for other IGIV products. Subcutaneous Administration Pharmacokinetic (PK) parameters of subcutaneously administered GAMMAGARD LIQUID were evaluated in subjects with primary immunodeficiency (PI) who were 12 years and older during a clinical study ( see CLINICAL STUDIES [ 14 ]) .
Subjects were treated intravenously for 12 weeks with GAMMAGARD LIQUID and then switched to weekly subcutaneous GAMMAGARD LIQUID infusions. Initially, all subjects were treated for a minimum of 12 weeks at a subcutaneous dose that was 130% of the intravenous dose. A comparison of the area under the curve (AUC) for intravenous and subcutaneous infusions done on the first 15 adult subjects determined that the subcutaneous dose required to provide an exposure from subcutaneous administration that was not inferior to the exposure from intravenous administration was 137% of the intravenous dose.
Subsequently, all subjects were treated with this dose for 6 weeks after which the dose was individualized for all subjects usin…
🧬 Mechanism of Action ▾
12.1Mechanism of Action GAMMAGARD LIQUID supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. GAMMAGARD LIQUID also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanisms of action of IgG in GAMMAGARD LIQUID have not been fully elucidated.
📋 Description ▾
11 DESCRIPTION GAMMAGARD LIQUID is a ready-for-use sterile, liquid preparation of highly purified and concentrated immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal plasma. The Fc and Fab functions are maintained in GAMMAGARD LIQUID.
Pre-kallikrein activator activity is not detectable. GAMMAGARD LIQUID contains 100 mg/mL protein. At least 98% of the protein is immune globulin, the average immunoglobulin A (IgA) concentration is 37 μg/mL, and immunoglobulin M is present in trace amounts.
GAMMAGARD LIQUID contains a broad spectrum of IgG antibodies against bacterial and viral agents. Glycine (0.25M) serves as a stabilizing and buffering agent, and there are no added sugars, sodium or preservatives. The pH is 4.6 to 5.1.
The osmolality is 240 to 300 mOsmol/kg, which is similar to physiological osmolality (285 to 295 mOsmol/kg). GAMMAGARD LIQUID is manufactured from large pools of human plasma. IgG preparations are purified from plasma pools using a modified Cohn-Oncley cold ethanol fractionation process, as well as cation and anion exchange chromatography.
Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of GAMMAGARD LIQUID is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), and for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found to be negative.
To further improve the margin of safety, three dedicated, independent and effective virus inactivation/removal steps have been integrated into the manufacturing and formulation processes, namely solvent/detergent (S/D) treatment 7 , 35 nm nanofiltration, and a low pH incubation at elevated temperature 30°C to 32°C. The S/D process includes treatment with an organic mixture of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80 at 18°C to 25°C for a minimum of 60 minutes. S/D treatment inactivates the lipid-enveloped viruses investigated to below detection limits within minutes.
In vitro virus spiking studies have been used to validate the capability of the manufacturing process to inactivate and remove viruses. To establish the minimum applicable virus clearance capacity of the manufacturing process, these virus clearance studies were performed under extreme conditions (e.g., at minimum S/D concentrations, incubation time and temperature for the S/D treatment). Virus clearance studies for GAMMAGARD LIQUID performed in accordance with good laboratory practices are summarized in Table 10 .
Table 10. Three Dedicated Independent Virus Inactivation/Removal Steps Mean Log 10 Reduction Factors For the calculation of these RF data from virus clearance study reports, applicable manufacturing conditions were used. Log 10 RFs on the order of 4 or more are considered effective for virus clearance in accordance with the Committee for Medicinal Products for Human Use (CHMP, formerly CPMP) guidelines.
(RFs) For Each Virus and Manufacturing Step Virus type Enveloped RNA Enveloped DNA Non-enveloped RNA Non-enveloped DNA Family Retroviridae Flaviviridae Herpesviridae Picornaviridae Parvoviridae Virus HIV-1 BVDV WNV PRV HAV EMCV MMV SD treatment >4.5 >6.2 n.a. >4.8 n.d. n.d. n.d 35 nm nanofiltration >4.5 >5.1 > 6.2 >5.6 5.7 1.4
2.0Low pH treatment >5.8 >5.5 > 6.0 >6.5 n.d. No RF obtained due to immediate neutralization of HAV by the anti-HAV antibodies present in the product. > 6.3
3.1Overall log reduction factor (ORF) >14.8 >16.8 >12.2 >16.9 5.7 b >7.7
5.1Abbreviations: HIV-1, Human Immunodeficiency Virus Type 1; BVDV, Bovine Viral Diarrhea Virus (model for Hepat…
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA approved patient labeling (Information for Patients) and instructions for use Inform patients to immediately report the following signs and symptoms to their healthcare provider: Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath ( see WARNINGS AND PRECAUTIONS [ 5.2 ] ) Acute chest pain, shortness of breath, leg pain, and swelling of the legs/feet, numbness in the face or extremities, weakness or paralysis, severe headache, confusion, visual disturbances ( see WARNINGS AND PRECAUTIONS [ 5.4 ] ).
Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting (see WARNINGS AND PRECAUTIONS [ 5.5 ]). Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine (see WARNINGS AND PRECAUTIONS [ 5.6 ]). Trouble breathing, chest pain, blue lips or extremities, or fever that can occur 1 to 6 hours after an infusion of GAMMAGARD LIQUID ( see WARNINGS AND PRECAUTIONS [ 5.7 ] ).
Prior to starting GAMMAGARD LIQUID ask about a history of IgA deficiency, allergic reactions to immune globulin or other blood products. Patients with a history of allergic reactions should not be treated subcutaneously at home until several treatments have been administered and tolerated under medical supervision. Inform patients that GAMMAGARD LIQUID is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the vCJD agent).
The risk of GAMMAGARD LIQUID transmitting an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and inactivating or removing certain viruses during manufacturing. Patients should report any symptoms that concern them which might be caused by virus infections (see WARNINGS AND PRECAUTIONS [ 5.8 ] ). Inform patients that GAMMAGARD LIQUID can interfere with their immune response to live viral vaccines such as measles, mumps, rubella and varicella, and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations (see DRUG INTERACTIONS [ 7 ] ).
Subcutaneous (SC) Administration Only Self-administration – If self-administration is deemed to be appropriate by the physician, clear instructions and training on subcutaneous infusion should be given to the patient/caregiver, and the demonstration of their ability to independently administer subcutaneous infusions should be documented. Ensure the patient understands the importance of consistent weekly subcutaneous infusion to maintain appropriate steady IgG levels. Instruct the patient to keep a treatment diary/log book.
This diary/log book should include information about each infusion such as, the time, date, dose, lot number(s) and any reactions. Inform the patient that mild to moderate local infusion-site reactions (e.g., swelling and redness) are a common side effect of subcutaneous treatment, but to contact their healthcare professional if a local reaction increases in severity or persists for more than a few days.