Dosage Form: injection, solution
FULL PRESCRIBING INFORMATION
- 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.
Indications and Usage for Gammagard Liquid
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 immunodeficiencies1,2.
Gammagard Liquid Dosage and Administration
Dosage
| 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.
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| 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 | 19 mL | 38 mL | 57 mL | 75 mL |
| 110 kg | 21 mL | 42 mL | 62 mL | 83 mL |
| 120 kg | 23 mL | 45 mL | 68 mL | 91 mL |
| 130 kg | 25 mL | 49 mL | 74 mL | 98 mL |
| 140 kg | 26 mL | 53 mL | 79 mL | 106 mL |
Example 1: A patient with a body weight of 80 kg has a measured IgG trough level of 800 mg/dL and the target trough level is 1000 mg/dL. The desired target trough level difference is 200 mg/dL (1000 mg/dL minus 800 mg/dL). The weekly dose of Gammagard Liquid should beincreased by 30 mL (3.0 gm).
Example 2: A patient with a body weight of 60 kg has a measured IgG trough of 1000 mg/dL and the target trough level is 800 mg/dL. The desired target trough level difference is 200 mg/dL (800 mg/dL minus 1000 mg/dL). The weekly dose of Gammagard Liquid should bedecreased by 23 mL (2.3 gm).
Preparation and Handling
- Inspect the drug product visually for particulate matter and discoloration prior to administration. Gammagard Liquid is a clear or slightly opalescent, colorless or pale yellow solution. Do not use if the solution is cloudy, turbid, or if it contains particulates.
- Gammagard Liquid vial is for single use only. Any vial that has been entered should be used promptly. Partially used vials should be discarded. Gammagard Liquid contains no preservative.
- Allow refrigerated product to come to room temperature before use.
- DO NOT MICROWAVE.
- Do not shake.
- Do not mix with other products.
- Do not use normal saline as a diluent. If dilution is desired, 5% dextrose in water (D5W) should be used as a diluent.
- The infusion line may be flushed with normal saline. An in-line filter is optional.
- Record the name and lot number of the product in the recipient's records.
Administration
Intravenous
| Initial | 0.5 mL/kg/hr (0.8 mg/kg/min) for 30 minutes |
| Subsequent | Increase every 30 minutes (if tolerated) up to 5 mL/kg/hr (8 mg/kg/min) |
Monitor patient vital signs throughout the infusion. Certain adverse reactions such as headaches, flushing and changes in pulse rate and blood pressure may be related to the rate of infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that does not result in recurrence of the symptoms.
Adverse reactions may occur more frequently in patients receiving immune globulin for the first time, upon switching brands or if there has been a long interval since the previous infusion2. In such cases, start at lower infusion rates and gradually increase as tolerated.
Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients over 65 years of age or judged to be at risk for renal dysfunction or thrombotic events, administer Gammagard Liquid at the minimum infusion rate practicable. In such cases, the maximal rate should be less than 3.3 mg/kg/min (< 2mL/kg/hr), and consider discontinuation of administration if renal function deteriorates. (see WARNINGS AND PRECAUTIONS [5.2, 5.4] and USE IN SPECIFIC POPULATION [8.5]).
Subcutaneous
| 40 kg BW and greater | Under 40 kg BW | |
| Initial | 30 mL/site at a rate of 20 mL/hr/site | 20 mL/site at a rate of 15 mL/hr/site |
| Maintenance | 30 mL/site at a rate of 20 to 30 mL/hr/site | 20 mL/site at a rate of 15 to 20 mL/hr/site |
Selection of Infusion Site: Suggested areas for subcutaneous infusion of Gammagard Liquid are abdomen, thighs, upper arms, or lower back. Infusion sites should be at least two inches apart, avoiding bony prominences. Rotate sites each week.
Volume per Site: The weekly dose (mL) should be divided by 30 or 20, based on patient weight above, to determine the number of sites required. Simultaneous subcutaneous infusion at multiple sites can be facilitated by use of a multi-needle administration set.
Rate of Infusion for Patients 40 kg and greater (88 lbs):If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites (e.g., 30 mL x 4 sites = 120 mL/hr). The number of simultaneous sites should be limited to 8, or maximum infusion rate of 240 mL/hr.
Rate of Infusion for Patients under 40 kg (88 lbs): If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites (e.g., 20 mL x 3 sites = 60 mL/hr). The number of simultaneous sites should be limited to 8, or maximum infusion rate of 160 mL/hr.
Instructions for Subcutaneous Administration: Instruct patients to observe the following procedures:
1. Aseptic technique- Use aseptic technique when preparing and infusing Gammagard Liquid.
2. Assemble supplies - Set up a clean work area and gather all supplies necessary for the subcutaneous infusion: vial(s) of Gammagard Liquid, ancillary supplies, sharps container and pump. If Gammagard Liquid has already been pooled into a bag or a syringe, skip to Step 5.
3. Product preparation - Remove the protective cap from the vial to expose the center of the vial. Wipe the stopper with an alcohol pad and allow to dry.
4. Withdraw Gammagard Liquid from the vials - Attach a sterile syringe to a needle and draw air into the syringe barrel equal to the amount of product to be withdrawn. Inject the air into the vial and withdraw the desired volume of Gammagard Liquid. If multiple vials are required to achieve the desired dose, repeat this step.
5. Prepare the infusion pump and tubing - Follow the manufacturer’s instructions for preparing the pump and administration tubing, if needed. Be sure to prime the pump tubing to ensure that no air is left in the tubing and needle.
6. Select the infusion sites - Select the number of infusion sites depending on the volume of the total dose. See Administration[2.3] for recommended maximum volumes and rates. Potential sites for infusion include the back of arms, abdomen, thighs, and lower back (see Figure below). Ensure sites are at least 2 inches apart; avoid bony prominences.
7. Cleanse the infusion site(s) - Cleanse the infusion site(s) with an antiseptic skin preparation (e.g., alcohol pad) using a circular motion working from the center of the site and moving to the outside. Allow to dry.
8. Insert the needle - Choose the correct needle length to assure that Gammagard Liquid is delivered into the subcutaneous space. Grasp the skin and pinch at least one inch of skin between two fingers. Insert needle at a 90 degree angle with a darting motion into the subcutaneous tissue. Secure the needle.
9. Check for proper needle placement – Prior to the start of infusion, check each needle for correct placement to make sure that a blood vessel has not been punctured. Gently pull back on the attached syringe plunger and monitor for any blood return in the needle set. If you see any blood, remove and discard the needle set. Repeat priming and needle insertion steps in a different infusion site with a new needle set.
10. Secure the needle to the skin - Secure the needle(s) in place by applying a sterile protective dressing over the site.
11. Start infusion of Gammagard Liquid – Follow the manufacturer’s instructions to turn pump on.
12. Document the infusion - Remove the peel-off label with product lot number and expiration date from the Gammagard Liquid vial and place in treatment diary/log book to keep track of the product lots used. Keep the treatment diary/log book current by recording the time, date, dose, product label and any reactions after each infusion.
13. Remove needle set – After the infusion is complete, remove the needle set and gently press a small piece of gauze over the needle insertion site and cover with a protective dressing. Discard any unused solution and disposable supplies in accordance with local requirements.
Dosage Forms and Strengths
Gammagard Liquid is an aqueous solution containing 10% IgG (100 mg/mL).
Contraindications
Hypersensitivity 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.
IgA 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 Precautions
Hypersensitivity
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] )
Renal 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 sucrose3. 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]).
Hyperproteinemia, 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 events4.
Thrombotic 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 history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular disease, or a history of a previous thrombotic or thromboembolic event.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies (see WARNINGS AND PRECAUTIONS [5.9]). For patients judged to be at risk of developing thrombotic events, 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]). When administering subcutaneously monitor the patients for signs and symptoms of thrombotic events.
Aseptic Meningitis Syndrome (AMS)
AMS may occur with IGIV treatment, and has been reported with intravenous use of Gammagard Liquid. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. The syndrome usually begins within several hours to two days following IGIV treatment.
AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. (see PATIENT COUNSELING INFORMATION [17]). Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination on patients exhibiting such symptoms and signs, including CSF studies, to rule out other causes of meningitis.
AMS may occur more frequently with high dose (2 g/kg) IGIV treatment and/or rapid infusion of IGIV.
Hemolysis
Gammagard Liquid contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immune globulin. These antibodies may cause a positive direct antiglobulin reaction and hemolysis3,5. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop due to enhanced RBC sequestration (see ADVERSE REACTIONS [6]).
Monitor patients for clinical signs and symptoms of hemolysis (see WARNINGS AND PRECAUTIONS [5.9]). If signs and/or symptoms of hemolysis such as dark colored urine, swelling, fatigue or difficulty breathing, are present after Gammagard Liquid infusion, perform appropriate confirmatory laboratory testing (see PATIENT COUNSELING INFORMATION [17]).
Transfusion-Related Acute Lung Injury (TRALI)
Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following treatment with IGIV products, including Gammagard Liquid. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically occur within 1 to 6 hours after treatment.
Monitor patients for pulmonary adverse reactions (see PATIENT COUNSELING INFORMATION[17]). If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil and anti-HLA antibodies in both the product and patient serum. TRALI 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, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the classic Creutzfeldt-Jakob disease agent. This also applies to unknown or emerging viruses and other pathogens. No cases of transmission of viral diseases or vCJD have been associated with Gammagard Liquid.
ALL infections thought by a physician to possibly have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.).
Monitoring: Laboratory Tests
- 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 BUN and serum creatinine, before the initial infusion of Gammagard Liquid and at appropriate intervals thereafter.
- Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis3.
- If signs and/or symptoms of hemolysis are present after an infusion of Gammagard Liquid, perform appropriate laboratory testing for confirmation.
- If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies and anti-HLA antibodies in both the product and patient’s serum.
Interference with Laboratory Tests
After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield false positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test.
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.
Clinical 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 subjects6. 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.
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| 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 causally related to the infusion of Gammagard Liquid.
| Event | By Infusion N (%) | By Subject N (%) |
| Headache | 90 (5%) | 27 (44%) |
| Pyrexia | 23 (1%) | 13 (21%) |
| Fatigue | 26 (1%) | 10 (16%) |
| Rigors | 14 (1%) | 8 (13%) |
| Nausea | 11 (1%) | 8 (13%) |
| Chills | 13 (1%) | 7 (12%) |
| Dizziness | 8 (0.4%) | 5 (8%) |
| Vomiting | 6 (0.3%) | 5 (8%) |
| Migraine | 16 (1%) | 4 (7%) |
| Pain in Extremity | 10 (1%) | 4 (7%) |
| Urticaria | 8 (0.4%) | 4 (7%) |
| Cough | 4 (0.2%) | 3 (5%) |
| Pruritus | 4 (0.2%) | 3 (5%) |
| Rash | 4 (0.2%) | 3 (5%) |
| Tachycardia | 3 (0.2%) | 3 (5%) |
31 of the 258 non-serious adverse events were not previously listed as associated with Gammagard Liquid and thus were considered unexpected. A total of 14 hospitalizations occurred during the study but none were related to infection.
Subcutaneous Administration
The safety of Gammagard Liquid subcutaneous infusion was evaluated in 47 subjects.
The most common ADRs with subcutaneous infusion of Gammagard Liquid observed in ≥5% of study subjects in the clinical trial were local infusion site reactions (e.g., swelling, redness, pain), as well as systemic reactions of headache, fever, fatigue, increased heart rate, increased systolic blood pressure, and upper abdominal pain.
Of the 632 non-serious AEs, the most frequent AEs, regardless of causality, and the most frequent temporally associated AEs, which occurred in ≥10% subjects, are shown in Table 7.
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Adverse Event | All Adverse Events | Adverse Events* Occurring Within 72 Hours of subcutaneous Infusion | ||
Number (%) of Subjects (N= 47) | Number (Rate†) of Adverse Events (N= 2294 Infusions) | Number (%) of Subjects (N= 47) | Number (Rate†) of Adverse Events (N= 2294 Infusions) | |
| Local Reactions | 21 (44.7) | 56 (0.028) | 21 (44.7) | 53 (0.027) |
| Headache | 23 (48.9) | 45 (0.020) | 18 (38.3) | 27 (0.012) |
| Fever | 14 (29.8) | 22 (0.010) | 9 (19.1) | 11 (0.005) |
| Nausea | 8 (17.0) | 20 (0.010) | 3 (6.4) | 6 (0.003) |
| Vomiting | 7 (14.9) | 12 (0.005) | 5 (10.6) | 7 (0.003) |
| Fatigue | 7 (14.9) | 11 (0.005) | 6 (12.8) | 10 (0.004) |
| Diarrhea | 5 (10.6) | 13 (0.006) | 3 (6.4) | 3 (0.001) |
| Asthma | 6 (12.8) | 9 (0.004) | 4 (8.5) | 6 (0.003) |
| Oropharyngeal Pain | 6 (12.8) | 8 (0.003) | 3 (6.4) | 3 (0.001) |
| Abdominal Pain Upper | 5 (10.6) | 12 (0.005) | 5 (10.6) | 9 (0.004) |
There were 150 AEs considered to be related to Gammagard Liquid use (ADRs), all of which were non-serious. Of these non-serious ADRs, 124 (83%) were rated as mild (transient discomfort that resolves spontaneously or with minimal intervention), 24 (16%) were rated as moderate (limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae), and 2 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. Neither of the severe AEs required hospitalization or resulted in sequelae.
The most frequent ADRs (AEs considered by the investigators to be at least possibly related to Gammagard Liquid) that occurred in 5% or more of subjects are shown in Table 8.
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| Adverse Reaction | Number (%) of Subjects (N= 47) | Number (Rate†) of Adverse Reactions (N= 2294 subcutaneous Infusions) |
| Local Reactions | 21 (44.7) | |
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