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%

Indication

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 disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAGARD S/D is also indicated for B-cell Chronic Lymphocytic Leukemia (CLL), Idiopathic Thombocytopenic Purpura (ITP) and Kawasaki Syndrome.

GAMMAGARD S/D is not indicated for patients with selective IgA deficiency (IgA < 0.05 g/L) where the IgA deficiency is the only abnormality of concern.

Important Risk Information for GAMMAGARD S/D

GAMMAGARD S/D is contraindicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern. Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.

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.

GAMMAGARD S/D should only be administered intravenously.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility.

GAMMAGARD S/D contains trace amounts of IgA (≤ 2.2 µg/mL in a 5% solution). It should be given with caution to patients with antibodies to IgA or IgA deficiencies, that are a component of an underlying primary immunodeficiency disease for which IGIV therapy is indicated. All IGIV preparations carry the risk of inducing an anaphylactic reaction to IgA.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Assure that patients are not volume depleted prior to the initiation of the infusion of IGIV. If renal function deteriorates, discontinuation of GAMMAGARD S/D should be considered. For patients judged to be at risk for developing renal dysfunction, it may be prudent to reduce the rate of infusion to 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.

Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex.

IGIV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced red blood cells (RBC) sequestration.

There have been reports of noncardiogenic pulmonary edema (Transfusion-Related Acute Lung Injury [TRALI]) in patients administered IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting, may occasionally occur.

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 disorders associated with defects in humoral immunity. These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAGARD S/D is also indicated for B-cell Chronic Lymphocytic Leukemia (CLL), Idiopathic Thombocytopenic Purpura (ITP) and Kawasaki Syndrome.

GAMMAGARD S/D is not indicated for patients with selective IgA deficiency (IgA < 0.05 g/L) where the IgA deficiency is the only abnormality of concern.

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

GAMMAGARD S/D is contraindicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern. Patients may experience severe hypersensitivity reactions or anaphylaxis in the setting of detectable IgA levels following infusion of GAMMAGARD S/D.

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.

GAMMAGARD S/D should only be administered intravenously.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility.

GAMMAGARD S/D, IgA <1 µg/mL, has a lower IgA concentration than GAMMAGARD S/D which has a concentration of 1 to 2.2 µg/mL. IGIV preparations depleted of IgA (0.4 to 2.9 µg/mL) were shown to be better tolerated by a limited number of patients who reacted to IGIV preparations with higher IgA concentrations. However, 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.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IGIV treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

Assure that patients are not volume depleted prior to the initiation of the infusion of IGIV. If renal function deteriorates, discontinuation of GAMMAGARD S/D should be considered. For patients judged to be at risk for developing renal dysfunction, it may be prudent to reduce the rate of infusion to 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.

Certain components used in the packaging of GAMMAGARD S/D contain natural rubber latex.

IGIV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced red blood cells (RBC) sequestration.

There have been reports of noncardiogenic pulmonary edema (Transfusion-Related Acute Lung Injury [TRALI]) in patients administered IGIV.

Thrombotic events have been reported in association with IGIV. Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity, hypercoagulable disorders, and prolonged periods of immobilization.

Various minor reactions, such as mild to moderate hypotension, headache, fatigue, chills, backache, leg cramps, lightheadedness, fever, urticaria, flushing, slight elevation of blood pressure, nausea and vomiting may occasionally occur.

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.