Gammaplex HUMAN IMMUNOGLOBULIN G 5 g/100mL Solution
🆔 Identity & classification
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🏭 Manufacturer & labeler
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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...
- What exactly is human immunoglobulin G and why do I need it?
- It depends on the specific product your doctor prescribed. The IV versions — like Privigen, Asceniv, Qivigy, and Gammaplex — are infused into a vein, usually every 3 to 4 weeks. Hi...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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0.6 g / 100 mL
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.
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5 g / 100 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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0.2 g / 100 mL
UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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0.3 g / 100 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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5 g / 100 mL
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
5 inactive ingredients 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 | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $11.63 | $2,326.44 / 200 ml |
| Medicare Part B allowsASP · J1557 | $66.272 / J1557 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Gammaplex 5 g/100mLthis 64208-8234-07 | Bio | 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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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 64208-8234-06 | 1 BOTTLE, GLASS in 1 CARTON (64208-8234-6) / 100 mL in 1 BOTTLE, GLASS (64208-8234-2) | 2010-11-01 | Active |
| 64208-8234-07 You're viewing this | 1 BOTTLE, GLASS in 1 CARTON (64208-8234-7) / 200 mL in 1 BOTTLE, GLASS (64208-8234-3) | 2010-11-01 | Active |
| 64208-8234-08 | 1 BOTTLE, GLASS in 1 CARTON (64208-8234-8) / 400 mL in 1 BOTTLE, GLASS (64208-8234-4) | 2010-11-01 | Active |
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What quantity is in NDC 64208-8234-07?
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🧭 About this NDC listing & data coverage
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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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
WARNING: ACUTE RENAL DYSFUNCTION and ACUTE RENAL FAILURE Use of Immune Globulin Intravenous (IGIV) products, particularly those containing sucrose, have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. 1 Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs (see Warnings and Precautions [5.2] ).
Gammaplex does not contain sucrose. For patients at risk of renal dysfunction or failure, administer Gammaplex at the minimum infusion rate practicable (see Dosage and Administration [2.3] , Warnings and Precautions [5.2] ). WARNING: RENAL DYSFUNCTION/ ACUTE RENAL FAILURE See full prescribing information for complete boxed warning.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Gammaplex does not contain sucrose.
For patients at risk of renal dysfunction or failure, administer Gammaplex at the minimum infusion rate practicable.
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Gammaplex is an Immune Globulin Intravenous (Human), 5% Liquid indicated for the replacement therapy of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Gammaplex is an Immune Globulin Intravenous (Human) indicated for the treatment of primary humoral immunodeficiency (PI).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For Intravenous Use Only Intravenous Use Only Indication Dose Initial infusion rate Maintenance rate (if tolerated) PI 300-800 mg/kg every 3-4 weeks 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes Increase to 4 mg/kg/min (0.08 mL/kg/min) Infuse Gammaplex intravenously using an intravenous infusion set preferably fitted with an in-line 15-20 micron filter ( 2.3 ). Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Gammaplex if renal function deteriorates ( 5.1 ).
For patients at risk of renal dysfunction or thrombotic events, administer Gammaplex at the minimum infusion rate practicable ( 5.1 , 5.2 ). Dosage forms and strengths Gammaplex is a liquid solution containing 5% IgG (50 mg/mL).
2.1Preparation and Handling Gammaplex is a clear or slightly opalescent, colorless solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is cloudy or turbid, or if it contains particulate matter.
Do not freeze, and do not use any solution that has been frozen. DO NOT SHAKE. Gammaplex should be at room temperature (up to 25°C [77°F]) at the time of administration.
Do not use Gammaplex beyond the expiration date on the product label. The Gammaplex vial is for single use only. Due to the absence of anti-microbial preservatives, promptly administer Gammaplex after piercing the cap.
Dispose of partially used or unused product in accordance with local requirements. Infuse Gammaplex using a separate infusion line. Do not mix Gammaplex with other intravenous medications (including normal saline) or other IGIV products.
An infusion pump may be used to control the rate of administration. If large doses of Gammaplex are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 2 hours after pooling.
2.2Recommended Dose As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response. The recommended dose of Gammaplex for patients with PI is 300 to 800 mg/kg (6 to 16 mL/kg), administered every 3 to 4 weeks.
Adjust the dosage over time to achieve the desired serum trough levels and clinical responses. 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.
2.3Administration Hydrate the patient adequately prior to the initiation of infusion. Due to the absence of anti-microbial preservatives, promptly administer Gammaplex after piercing the cap. Infuse Gammaplex intravenously using an intravenous infusion set preferably fitted with an in-line 15-20 micron filter.
Table 1: Recommended Infusion Rates for Gammaplex Indication Initial infusion rate for first 15 minutes Maintenance infusion rate (if tolerated) PI 0.5 mg/kg/min (0.01 mL/kg/min) Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/min) Monitor vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
The observation time of patients after Gammaplex administration may vary. If the patient (a) has not received Gammaplex or another IgG product, (b) is switched from an alternative IGIV product or (c) has had a long interval since the previous infusion, prolong the observation time for adverse reactions after Gammaplex infusion. Certain severe adverse drug reactions may be related to the rate of infusion.
Slowing or stopping the infusion often allows the reaction to disappear promptly. Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombotic events…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Gammaplex is a liquid solution containing 5% IgG (50 mg/mL).
⛔ Contraindications ▾
4 CONTRAINDICATIONS Gammaplex is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. Gammaplex is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. History of anaphylactic or severe systemic reactions to human immunoglobulin ( 4 ). IgA-deficient patients with antibodies against IgA and a history of hypersensitivity ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Weigh the potential risks and benefits of Gammaplex against those of alternative therapies in all patients for whom Gammaplex is being considered. Before prescribing Gammaplex, the physician should discuss the risks and benefits of its use with the patient. IgA-deficient patients with antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions ( 5.1 ).
Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine, and urine output in patients at risk of developing acute renal failure ( 5.2 ). Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy ( 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 of hyperviscosity ( 5.4 ). Aseptic meningitis syndrome may occur, especially with high doses or rapid infusion ( 5.5 ). Hemolysis can develop subsequent to IGIV treatments.
Monitor patients for hemolysis and hemolytic anemia ( 5.6 ). Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]) ( 5.7 ). Gammaplex is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent ( 5.8 ).
Passive transfer of antibodies may confound serologic testing ( 5.10 ).
5.1Hypersensitivity Severe hypersensitivity reactions may occur (see Contraindications [4] ). In case of hypersensitivity, discontinue Gammaplex infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions.
Gammaplex contains trace amounts of IgA (<10 μg/mL) (s ee Description [11] ). Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Gammaplex 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, osmotic nephropathy, and death 1 may occur upon use of human IGIV products. Ensure that patients are not volume depleted before administering Gammaplex. 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, hypovolemia, overweight, use of concomitant nephrotoxic medicinal products or age of >65 years), administer Gammaplex at the minimum infusion rate practicable ( 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 of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Gammaplex and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing Gammaplex.
5.3Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV therapy. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with 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 possible predisposition to thrombotic events.
2
5.4Thrombotic Events Thrombotic events may occur following treatment with Gammaplex and other IGIV products. 2,3 Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonge…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Two serious adverse reactions, thrombosis and chest pain, were observed in a clinical study subject receiving Gammaplex. The most common adverse reactions to Gammaplex (reported in >5% of clinical trial subjects) were headache, fatigue, nausea, pyrexia, hypertension, myalgia, pain, and vomiting. The most common adverse reactions during clinical trial (reported in >5% of subjects) were headache, fatigue, nausea, pyrexia, hypertension, myalgia, pain, and vomiting (6).
To report SUSPECTED ADVERSE REACTIONS, contact FFF on behalf of Bio Products Laboratory at 1-800-843-7477 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies 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. In a multicenter, open-label, non-randomized clinical study, 50 subjects with primary humoral immunodeficiency received doses of Gammaplex ranging from 279 to 799 mg/kg every 21days (mean dose 465 mg/kg) or 28 days (mean dose 458 mg/kg), for up to 12 months ( see Clinical Studies [14.1] ).
Routine premedication was not allowed. Of the 703 infusions administered, 2 (4%) subjects received premedication (antipyretic, antihistamine, or antiemetic agent) prior to 2 courses of treatment, because of experience with consecutive infusion-related adverse reactions. All 50 subjects had an adverse event at some time during the study.
Twenty-four subjects (48.0%) had an adverse reaction at some time during the study that was considered product-related. More subjects with the 21-day infusion cycle had at least one adverse reaction (14 of 22 subjects, 63.6%) than subjects with the 28-day infusion cycle (10 of 28 subjects, 35.7%). Of these 24 subjects who showed adverse reactions, only 3 subjects had adverse reactions that were considered definitely related to Gammaplex: headache, pyrexia, tachycardia, chest discomfort, and hypertension.
The most common adverse reactions observed in this clinical trial were headache (18 subjects, 36.0%), fatigue (6 subjects, 12.0%), nausea (6 subjects, 12.0%), pyrexia (6 subjects, 12.0%), hypertension (3 subjects, 6.0%), myalgia (3 subjects, 6.0%), pain (3 subjects, 6.0%), and vomiting (3 subjects, 6.0%). Temporally associated adverse events (AEs) are those occurring during or within 72 hours after the end of an infusion, irrespective of causality . In this study, the upper bound of the 1-sided 97.5% confidence interval for the proportion of Gammaplex infusions temporally associated with one or more AEs was 24.2% (actual proportion: 21.2%).
This is below the target of 40% for this safety endpoint. The total number of temporally associated AEs was 237 (a rate of
0.34AEs per infusion), reflecting that some subjects experienced more than one AE during the observation period. Table 2 lists the temporally associated AEs that occurred in more than 5% of subjects during a Gammaplex infusion or within 72 hours after the end of an infusion, irrespective of causality . Table 2: Adverse Events Occurring in >5% of Subjects with PI during a Gammaplex Infusion or within 72 Hours after the End of an infusion, Irrespective of Causality Adverse Event Subjects (%) [n=50] Infusions (%) [n=703] Headache 18 (36%) 53 (7.5%) Sinusitis 8 (16%) 9 (1.3%) Pyrexia 7 (14%) 10 (1.4%) Nausea 6 (12%) 7 (1.0%) Pain 5 (10%) 5 (0.7%) Chills 3 (6%) 5 (0.7%) Fatigue 3 (6%) 9 (1.3%) Hypertension 3 (6%) 4 (0.6%) Insomnia 3 (6%) 3 (0.4%) Nasal Congestion 3 (6%) 3 (0.4%) Upper respiratory tract infection 3 (6%) 5 (0.7%) Vomiting 3 (6%) 3 (0.4%) Of the 237 temporally associated AEs reported for the 50 subjects, the investigators judged 115 to be related to the infusion of Gammaplex.
The most common temporally associated AEs judged to be related to Gammaplex infusion were headache (32% of subjects), pyrexia (8% of su…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines such as measles, mumps, rubella and varicella. 11,12 Inform the immunizing physician of recent therapy with Gammaplex so that appropriate measures may be taken ( see Patient Counseling Information [17] ). Passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines, such as measles, mumps, and rubella ( 7 ).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: No human or animal data. Use only if clearly indicated. ( 8.1 ) Geriatrics: In patients over age 65 or in any patient at risk of developing renal insufficiency, do not exceed the recommended dose and infuse Gammaplex at the minimum rate practicable. ( 8.5 )
8.1Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Gammaplex. It is also not known whether Gammaplex can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gammaplex should be given to a pregnant woman only if clearly needed. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation 13, 14
8.3Nursing Mothers Use of Gammaplex has not been evaluated in nursing mothers.
8.4Pediatric Use Six (6) pediatric patients with primary humoral immunodeficiency (2 between ages of 9 and 10, and 4 between ages 12 and 16) were included within the clinical evaluation of Gammaplex. This number of pediatric patients was too small for separate evaluation from the adult patients for safety or efficacy ( see Clinical Studies [14] ).
8.5Geriatric Use Use caution when administering Gammaplex to patients age 65 and over who are judged to be at increased risk of developing renal insufficiency or thrombotic events ( see Boxed Warning , Warnings and Precautions [5.2 , 5.4] ). Do not exceed recommended doses, and administer Gammaplex at the minimum infusion rate practicable. Eight (8) patients with primary humoral immunodeficiency at or over the age of 65 were included within the clinical evaluation of Gammaplex.
This number of geriatric patients was too small for separate evaluation from the younger patients for safety or efficacy ( see Clinical Studies [14] ).
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Gammaplex. It is also not known whether Gammaplex can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Gammaplex should be given to a pregnant woman only if clearly needed. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation 13, 14
🧒 Pediatric Use ▾
8.4Pediatric Use Six (6) pediatric patients with primary humoral immunodeficiency (2 between ages of 9 and 10, and 4 between ages 12 and 16) were included within the clinical evaluation of Gammaplex. This number of pediatric patients was too small for separate evaluation from the adult patients for safety or efficacy ( see Clinical Studies [14] ).
🧓 Geriatric Use ▾
8.5Geriatric Use Use caution when administering Gammaplex to patients age 65 and over who are judged to be at increased risk of developing renal insufficiency or thrombotic events ( see Boxed Warning , Warnings and Precautions [5.2 , 5.4] ). Do not exceed recommended doses, and administer Gammaplex at the minimum infusion rate practicable. Eight (8) patients with primary humoral immunodeficiency at or over the age of 65 were included within the clinical evaluation of Gammaplex.
This number of geriatric patients was too small for separate evaluation from the younger patients for safety or efficacy ( see Clinical Studies [14] ).
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Gammaplex is a replacement therapy for primary humoral immunodeficiency. It acts through a broad spectrum of opsonic and neutralizing IgG antibodies against pathogens and their toxins involving antigen binding and effector functions 15,16 . However, the mechanism of action in PI has not been fully elucidated.
12.3Pharmacokinetics In the clinical study assessing safety and efficacy in primary humoral immunodeficiency, the pharmacokinetics of Gammaplex was assessed for 28 days after administration to 24 subjects on 21- or 28-day infusion cycles. Blood samples for pharmacokinetic (PK) analysis were obtained after Infusion 9 for subjects on a 21-day schedule (9 subjects) and after Infusion 7 for subjects on a 28-day schedule (15 subjects), i.e., during the sixth month after initiation of Gammaplex treatment. The mean dose (range) for those on the 21-day schedule was 476 mg/kg (range: 330 to 721 mg/kg), and it was 468 mg/kg (range: 324 to 799 mg/kg) for those on the 28-day schedule.
Table 4 summarizes the PK parameters of Gammaplex, measured as serum concentrations of total IgG. Assessment of the clinical relevance of half-life measurements in this study should be viewed with caution. Although half-life estimates are provided for total IgG and the specific antibodies, drug elimination half-lives should be measured over a minimum period of at least 3 half-lives.
However, the short dosing intervals relative to the long half-life of IgG in this clinical trial do not permit accurate assessment of half-life. Table 4: Pharmacokinetic Parameters of Gammaplex in Subjects with PI Parameter (unit) 21-day Dosing Interval (n=9) 28-day Dosing Interval (n=15) Mean ± SD (Range) Mean ± SD (Range) tau = dosing interval C max (mg/mL) 21.6 ± 3.8 (16.3-27.3) 21.4 ± 4.3 (15.9-31.0) T max (hr) 5.4 ± 7.2 (2.1-24.5) 6.1 ± 11.6 (2.4-48.1) AUC 0-tau (days*mg/mL) 289 ± 41 (214-365) 346 ± 52 n=14 for these calculations (262-455) Half-Life (days) 42 ± 26 (22-108) 41 ± 14 (22-70) Clearance (mL/days/kg) 0.59 ± 0.24 (0.19-1.02) 0.58 ± 0.27 (0.24-1.28)
🧬 Mechanism of Action ▾
12.1Mechanism of Action Gammaplex is a replacement therapy for primary humoral immunodeficiency. It acts through a broad spectrum of opsonic and neutralizing IgG antibodies against pathogens and their toxins involving antigen binding and effector functions 15,16 . However, the mechanism of action in PI has not been fully elucidated.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Gammaplex is supplied in a single use, clear Type II glass bottle, closed with a stopper (13% natural rubber) and oversealed with a tamper-evident cap. The following presentations of Gammaplex are available: NDC Number Grams and Fill Size 64208-8234-1 2.5g in 50 mL 64208-8234-2 5 g in 100 mL 64208-8234-3 10 g in 200 mL Each vial has a label with a peel-off strip showing the product name and batch number. When stored between 2 °C [35.6 °F] and 25 °C [77 °F]), Gammaplex has a shelf life of 24 months, as indicated by the expiration date printed on the outer carton and vial label.
Keep Gammaplex in its original carton to protect it from light. DO NOT FREEZE.
📦 Storage and Handling ▾
When stored between 2 °C [35.6 °F] and 25 °C [77 °F]), Gammaplex has a shelf life of 24 months, as indicated by the expiration date printed on the outer carton and vial label. Keep Gammaplex in its original carton to protect it from light. DO NOT FREEZE.
📋 Description ▾
11 DESCRIPTION Gammaplex is a ready to use sterile solution of polyclonal human Immunoglobulin G for IV administration that contains sorbitol, glycine and polysorbate 80 as stabilizers. Specifically, Gammaplex contains approximately 5 g normal human immunoglobulin and 5 g D-sorbitol in 100 mL of buffer solution containing: 0.6 g glycine, 0.2 g sodium acetate, 0.3 g sodium chloride, and ~5 mg polysorbate 80. Immunoglobulin G purity is > 95%, the pH is in the range of 4.8 to 5.1, and osmolality is not less than 240 mOsmol/kg (typically 420 to 500 mOsmol/kg).
The distribution of the four IgG subclasses is approximately 64% IgG1, 30% IgG2, 5% IgG3, and 1% IgG4. The content of IgA is lower than 10 µg/mL. The anti-D and anti-A/anti-B hemagglutinin content of the drug product is strictly controlled to specification.
Gammaplex contains no reducing carbohydrate stabilizers (e.g. sucrose, maltose) and no preservative. Gammaplex is prepared from large pools of human plasma by a combination of cold ethanol fractionation and ion exchange chromatography. Fab functions tested include antigen binding activity, and Fc functions tested include complement activation and rubella antibody-mediated hemolysis.
Gammaplex is manufactured from plasma, obtained from healthy US donors, that have passed viral screening tests. All donors are subjected to medical examinations, laboratory tests, and a review of their medical history before being allowed to donate blood or plasma. There are several stages within this manufacturing process that contribute to viral reduction, including management of donors, screening of donations and specific virus removal steps during manufacturing.
All plasma donations are screened for antibody to HIV-1/2 and HCV, and hepatitis B surface antigen (HBsAg). Furthermore, plasma mini-pools (512 donations per pool) undergo nucleic acid amplification testing (NAT) for HIV, hepatitis B virus (HBV), HCV, hepatitis A virus (HAV) and Parvovirus B19. Further testing is carried out on the manufacturing pools for HBsAg, and antibody to HIV-1/2; HCV and Parvovirus B19 are also tested by NAT, with the limit for B19 set to not exceed 10 4 IU B19 DNA per mL plasma.
There are three processing steps specifically designed to remove or inactivate viruses: 1) Solvent/Detergent treatment is targeted to enveloped viruses; 2) A virus filtration step using Pall Ultipor DV20 is designed to remove small viruses including non-enveloped viruses, on a size exclusion basis; and 3) The terminal low pH incubation step is identified as contributing to the overall viral clearance capacity for enveloped and non-enveloped viruses. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model.
Overall virus reduction was calculated only from steps that were mechanistically independent from each other. In addition, each step was validated to provide robust virus reduction. The table below presents the contribution of each process step to virus reduction and the overall process reduction.
Table 3: Viral Reduction by Process Step Virus Type (Envelope/Genome) Size (nm) Process Log 10 Reduction of Virus (LRV) over manufacturing step Total LRV Solvent Detergent 20 nm filtration Terminal low pH/elevated temperature incubation HIV: Human immunodeficiency virus SIN: Sindbis virus, model for hepatitis C virus (HCV) WNV: West Nile Virus BVDV: Bovine viral diarrhea virus, model for HCV IBR: Infectious bovine rhinotracheitis, bovine herpesvirus model for enveloped DNA viruses including hepatitis B HAV: Hepatitis A virus EMC: Encephalomyocarditis, model for HAV NA: Not applicable, solvent detergent step is limited to the inactivation of enveloped viruses I: Inactivation by the product intermediate precluded the accurate estimation of the removal of these viruses by the filtration step NT: Not tested B19: Viral clearance of Human Parvovirus B19 was investiga…
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Inform patients to immediately report the following signs and symptoms to their healthcare professional: 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 ( 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 skin or eyes, dark-colored urine ( see Warnings and Precautions [5.6] ). Trouble breathing, chest pain, blue lips or extremities, fever ( see Warnings and Precautions [5.7] ). Inform patients that Gammaplex is made from human plasma and may contain infectious agents that can cause disease.
While the risk that Gammaplex can transmit an infection 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 ( see Warnings and Precautions [5.8] ). Inform patients that Gammaplex can interfere with their immune response to live viral vaccines (e.g., measles, mumps, and rubella), and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations ( see Drug Interactions [7] ).