1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% for Patients
2. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% for Healthcare Professionals
3. GAMMAGARD S/D [Immune Globulin Intravenous (Human)]
4. GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 µg/mL in a 5% solution

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%

Indications

GAMMAGARD LIQUID is used to treat patients with primary immunodeficiency diseases (PI). There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. GAMMAGARD LIQUID is made from human plasma that is donated by healthy people. GAMMAGARD LIQUID contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.

Detailed Important Risk Information for Patients

Tell your healthcare provider about any side effect that bothers you or that does not go away.

GAMMAGARD LIQUID can cause the following serious reactions:

• Severe allergic reactions causing difficulty in breathing or skin rashes
• Decreased kidney function or kidney failure
• Blood clots in the heart, brain, lungs or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Dark colored urine, swelling, fatigue, or difficulty breathing

Tell your healthcare provider if you have a history of poor kidney function or kidney failure. If so, GAMMAGARD LIQUID should be administered at the slowest intravenous infusion rate as determined by your healthcare provider.

Contact your healthcare provider or call emergency services immediately if you have reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.

Do not use GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if GAMMAGARD LIQUID can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

If any of the following problems occur after starting treatment with GAMMAGARD LIQUID, stop the infusion immediately and contact your healthcare provider or call emergency services. These could be signs of a serious problem.

• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem.
• Chest pain or trouble breathing, blue lips or extremities. These could be signs of a serious heart or lung problem.
• Fever over 100°F. This could be a sign of an infection.

These are not all of the possible side effects with GAMMAGARD LIQUID. You can ask your healthcare provider for physician’s information leaflet.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting viruses.

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.

During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects:

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help should a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.

Please see the Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% for full prescribing details.

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GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%

Indication

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.

Detailed Important Risk Information for Healthcare Professionals

• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
• Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMMAGARD LIQUID does not contain sucrose.
• For patients at risk of renal dysfunction or failure, administer GAMMAGARD LIQUID at the minimum infusion rate practicable.

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

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.

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.

Severe hypersensitivity reactions may occur, even in patients who had tolerated previous treatment with human normal immune globulin.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving GAMMAGARD LIQUID.

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. 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.

Aseptic Meningitis Syndrome 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.

GAMMAGARD LIQUID contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immune globulin. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop due to enhanced RBC sequestration

Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following treatment with IGIV products, including GAMMAGARD LIQUID.

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.

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.

Please see the Full Prescribing Information for GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% for full prescribing details.

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GAMMAGARD S/D [Immune Globulin Intravenous (Human)]

Indications

GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAGARD S/D is also indicated for prevention of recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL), treatment of adult chronic Idiopathic Thrombocytopenic Purpura (ITP) to increase platelet count and to prevent and/or control bleeding, and prevention of coronary artery aneuryisms associated with Kawasaki Syndrome in pediatric patients.

Important Risk Information for GAMMAGARD S/D

• Intravenous use of human immune globulin (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. 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 those receiving known nephrotoxic drugs. GAMMAGARD S/D does not contain sucrose.
• For patients at risk of renal dysfunction or failure, administer GAMMAGARD S/D at the minimum concentration available and the minimum rate of infusion practicable.

For Intravenous Use Only

Assure that patients are not volume depleted prior to the initiation of the infusion of GAMMAGARD S/D. In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure, administer GAMMAGARD S/D at an infusion rate less than 4 mL/kg/Hr (< 3.3 mg IG/kg/min) for a 5% solution or at a rate less than 2 mL/kg/Hr (< 3.3 mg IG/kg/min) for a 10% solution.

GAMMAGARD S/D is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of human immunoglobulin.

GAMMAGARD S/D is contraindicated in IgA deficient patients with antibodies to IgA and a history of hypersensitivity.

Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure have occurred in patients receiving GAMMAGARD S/D, including patients who tolerated previous treatments with GAMMAGARD S/D, even though it contains low levels of IgA.

GAMMAGARD S/D contains trace amounts of IgA (≤ 2.2 µg/mL in a 5% solution). Patients with IgA deficiency and antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

Thromboembolic events, including myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism, have been reported in association with IGIV therapy, including GAMMAGARD S/D. Patients at risk for thromboembolic events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, known or suspected hyperviscosity, hypercoagulable disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular diseases, and a history of a previous thrombotic or thromboembolic event. For patients judged to be at risk of developing thrombotic events, administer GAMMAGARD S/D at the minimum rate of infusion practicable.

Aseptic Meningitis Syndrome (AMS) has been reported to occur in association with IGIV therapy, including GAMMAGARD S/D. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. AMS may occur more frequently with high dose (2 g/kg) IGIV treatment.

Hemolytic anemia can develop subsequent to IGIV therapy, including GAMMAGARD S/D. GAMMAGARD S/D contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration.

Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following the administration of gammaglobulin products, including GAMMAGARD S/D therapy.

GAMMAGARD S/D is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

Hyperproteinemia and increased serum viscosity may occur in patients receiving GAMMAGARD S/D. The amount of sodium in the product may add materially to the recommended daily allowance of dietary sodium for patients on a low sodium diet. In these patients, calculate the amount of sodium from the product and use it when determining dietary sodium intake.

Certain components used in the packaging of this product contain natural rubber latex. Use GAMMAGARD S/D cautiously in patients with sensitivity to rubber latex.

The most common adverse reactions observed in ≥ 5% of patients during the clinical trials were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis and flushing.

Severe adverse reactions reported postmarketing include renal failure, thrombotic events (myocardial infarction, cerebrovascular accidents, and pulmonary embolism), anaphylactic shock, aseptic meningitis and hemolysis.

Please see the Full Prescribing Information for GAMMAGARD S/D [Immune Globulin Intravenous (Human)] for full prescribing details.

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GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 μg/mL in a 5% solution

Indications

GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAGARD S/D is also indicated for prevention of recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL), treatment of adult chronic Idiopathic Thrombocytopenic Purpura (ITP) to increase platelet count and to prevent and/or control bleeding, and prevention of coronary artery aneuryisms associated with Kawasaki Syndrome in pediatric patients.

Important Risk Information for GAMMAGARD S/D, IgA less than 1 μg/mL in a 5% solution

• Intravenous use of human immune globulin (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. 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 those receiving known nephrotoxic drugs. GAMMAGARD S/D does not contain sucrose.
• For patients at risk of renal dysfunction or failure, administer GAMMAGARD S/D at the minimum concentration available and the minimum rate of infusion practicable.

For Intravenous Use Only

Assure that patients are not volume depleted prior to the initiation of the infusion of GAMMAGARD S/D. In patients who are at risk of developing renal dysfunction, because of pre-existing renal insufficiency or predisposition to acute renal failure, administer GAMMAGARD S/D at an infusion rate less than 4 mL/kg/Hr (< 3.3 mg IG/kg/min) for a 5% solution or at a rate less than 2 mL/kg/Hr (< 3.3 mg IG/kg/min) for a 10% solution.

GAMMAGARD S/D is contraindicated in patients who have had a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with < 1 µg/mL IgA in a 5% solution.

Severe hypersensitivity reactions and anaphylactic reactions with a fall in blood pressure have occurred in patients receiving GAMMAGARD S/D, including patients who tolerated previous treatments with GAMMAGARD S/D, even though it contains low levels of IgA.

The concentration of IgA that will not provoke a reaction is not known, and therefore all IGIV preparations carry the risk of inducing an anaphylactic reaction to IgA. In such instances, a risk of anaphylaxis may exist despite the fact that GAMMAGARD S/D, IgA < 1 µg/mL, contains trace amounts of IgA.

Thromboembolic events, including myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism, have been reported in association with IGIV therapy, including GAMMAGARD S/D. Patients at risk for thromboembolic events include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, known or suspected hyperviscosity, hypercoagulable disorders, prolonged periods of immobilization, obesity, diabetes mellitus, acquired or inherited thrombophilic disorder, a history of vascular diseases, and a history of a previous thrombotic or thromboembolic event. For patients judged to be at risk of developing thrombotic events, administer GAMMAGARD S/D at the minimum rate of infusion practicable.

Aseptic Meningitis Syndrome (AMS) has been reported to occur in association with IGIV therapy, including GAMMAGARD S/D. Discontinua¬tion of IGIV treatment has resulted in remission of AMS within several days without sequelae. AMS may occur more frequently with high dose (2 g/kg) IGIV treatment.

Hemolytic anemia can develop subsequent to IGIV therapy, including GAMMAGARD S/D. GAMMAGARD S/D contains blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Acute intravascular hemolysis has been reported, and delayed hemolytic anemia can develop subsequent to IGIV therapy due to enhanced RBC sequestration.

Non-cardiogenic pulmonary edema (TRALI) has been reported in patients following the administration of gammaglobulin products, including GAMMAGARD S/D therapy.

GAMMAGARD S/D is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

Hyperproteinemia and increased serum viscosity may occur in patients receiving GAMMAGARD S/D. The amount of sodium in the product may add materially to the recommended daily allowance of dietary sodium for patients on a low sodium diet. In these patients, calculate the amount of sodium from the product and use it when determining dietary sodium intake.

Certain components used in the packaging of this product contain natural rubber latex. Use GAMMAGARD S/D cautiously in patients with sensitivity to rubber latex.

The most common adverse reactions observed in ≥ 5% of patients during the clinical trials were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis and flushing.

Severe adverse reactions reported postmarketing include renal failure, thrombotic events (myocardial infarction, cerebrovascular accidents, and pulmonary embolism), anaphylactic shock, aseptic meningitis and hemolysis.

Please see the Full Prescribing Information for GAMMAGARD S/D [Immune Globulin Intravenous (Human)], IgA less than 1 µg/mL in a 5% solution for full prescribing details.