Gammagard

DRUG DESCRIPTION

GAMMAGARD S/D, Immune Globulin Intravenous (Human) [IGIV] is a solvent/detergent treated, sterile, freeze-dried preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. The product is manufactured by the Cohn-Oncley cold ethanol fractionation process followed by ultrafiltration and ion exchange chromatography. Source material for fractionation may be obtained from another U.S. licensed manufacturer. The manufacturing process includes treatment with an organic solvent/detergent mixture,1,2 composed of tri-n-butyl phosphate, octoxynol 9 and polysorbate 80.3 The GAMMAGARD (immune globulin) S/D manufacturing process provides a significant viral reduction in in vitro studies.3 These studies, summarized in Table 1, demonstrate virus clearance during GAMMAGARD S/D manufacturing using infectious human immunodeficiency virus, Types 1 and 2 (HIV-1, HIV-2); bovine viral diarrhea virus (BVD), a model virus for hepatitis C virus; sindbis virus (SIN), a model virus for lipid-enveloped viruses; pseudorabies virus (PRV), a model virus for lipid-enveloped DNA viruses such as herpes; vesicular stomatitis virus (VSV), a model virus for lipid-enveloped RNA viruses; hepatitis A virus (HAV) and encephalomyocarditis virus (EMC), a model virus for non-lipid enveloped RNA viruses; and porcine parvovirus (PPV), a model virus for non-lipid enveloped DNA viruses.3 These reductions are achieved through a combination of process chemistry, partitioning and/or inactivation during cold ethanol fractionation and the solvent/detergent treatment.3

Table 1: In Vitro Virus Clearance During Gammagard S/D (immune globulin) Manufacturing

Process Step Evaluated Virus Clearance (log10)
Lipid Enveloped Viruses Non-Lipid Enveloped Viruses
BVD HIV-1 HIV-2 PRV SIN VSV EMC HAV PPV
Step 1 : Processing of Cryo-Poor Plasma to Fraction I+II+III Precipitate 0.6* 5.7 NT 1.0* NT NT NT 0.5* 0.2*
Step 2 : Processing of Resuspended Suspension A Precipitate to Suspension B Filter Press Filtrate 1.3 4.9 NT 3.7 NT NT 3.7 4.1 3.5
Step 3 : Processing of Suspension B Filter Press to Suspension B Cuno 70 Filtrate 0.7* 4.0 NT 4.5 NT NT 3.0 3.9 3.9
Step 4 : Solvent/Detergent Treatment > 4.9 > 3.7 5.7 > 4.1 5.1 6.0 NA NA NA
Cumulative Reduction of Virus (log10) 6.2 18.3 5.7 12.3 5.1 6.0 6.7 8.0 7.4
* These values are not included in the computation of the cumulative reduction of virus since the virus clearance is within the variability limit of the assay ( ? 1.0).
NA Not Applicable. Solvent/detergent treatment does not affect non-lipid enveloped viruses.
NT Not Tested.

When reconstituted with the total volume of diluent (Sterile Water for Injection, USP) supplied, this preparation contains approximately 50 mg of protein per mL (5%), of which at least 90% is gamma globulin. The product, reconstituted to 5%, contains a physiological concentration of sodium chloride (approximately 8.5 mg/mL) and has a pH of 6.8 ? 0.4. Stabilizing agents and additional components are present in the following maximum amounts for a 5% solution: 3 mg/mL Albumin (Human), 22.5 mg/mL glycine, 20 mg/mL glucose, 2 mg/mL polyethylene glycol (PEG), 1 g/mL tri-n-butyl phosphate, 1 g/mL octoxynol 9, and 100 g/mL polysorbate 80. If it is necessary to prepare a 10% (100 mg/mL) solution for infusion, half the volume of diluent should be added, as described in the DOSAGE AND ADMINISTRATION. In this case, the stabilizing agents and other components will be present at double the concentrations given for the 5% solution. The manufacturing process for GAMMAGARD S/D (immune globulin) , isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. GAMMAGARD (immune globulin) S/D contains all of the IgG antibody activities which are present in the donor population. On the average, the distribution of IgG subclasses present in this product is similar to that in normal plasma.3

GAMMAGARD S/D (immune globulin) contains only trace amounts of IgA ( ? 2.2 g/mL in a 5% solution). IgM is also present in trace amounts.

GAMMAGARD S/D, Immune Globulin Intravenous (Human) contains no preservative.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • trouble breathing, blue lips;
  • fever with headache, neck stiffness, chills, increased...

Read All Potential Side Effects and See Pictures of Gammagard

What are the precautions when taking immune globulin (Gammagard)?

See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products are made with maltose....

Read All Potential Precautions of Gammagard

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • trouble breathing, blue lips;
  • fever with headache, neck stiffness, chills, increased...

Read All Potential Side Effects and See Pictures of Gammagard

What are the precautions when taking immune globulin (Gammagard)?

See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products are made with maltose....

Read All Potential Precautions of Gammagard

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • trouble breathing, blue lips;
  • fever with headache, neck stiffness, chills, increased...

Read All Potential Side Effects and See Pictures of Gammagard

What are the precautions when taking immune globulin (Gammagard)?

See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products are made with maltose....

Read All Potential Precautions of Gammagard

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • trouble breathing, blue lips;
  • fever with headache, neck stiffness, chills, increased...

Read All Potential Side Effects and See Pictures of Gammagard

What are the precautions when taking immune globulin (Gammagard)?

See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products are made with maltose....

Read All Potential Precautions of Gammagard

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • trouble breathing, blue lips;
  • fever with headache, neck stiffness, chills, increased...

Read All Potential Side Effects and See Pictures of Gammagard

What are the precautions when taking immune globulin (Gammagard)?

See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products are made with maltose....

Read All Potential Precautions of Gammagard


Gammagard Consumer (continued)

SIDE EFFECTS: Flushing, headache, dizziness, chills, muscle cramps, back/joint pain, fever, nausea, or vomiting may occur. Tell your doctor or other health care professional immediately if any of these effects occur, persist, or worsen. Pain, redness, and swelling at the injection site may also occur. If these effects continue or become bothersome, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, fainting, fast/irregular heartbeat, unusual tiredness.

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you are severely dehydrated, or have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as very long plane flights or bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.

Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.

Treatment with this medication may rarely cause a serious inflammation of the brain (aseptic meningitis syndrome) several hours to 2 days after your treatment. Get medical help right away if you develop severe headache, stiff neck, drowsiness, high fever, sensitivity to light, eye pain, or severe nausea/vomiting.

Lung problems may rarely occur 1 to 6 hours after your treatment. You will be monitored closely for any lung problems after your treatment.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See Side Effects section.

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., CMV IgG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain immune system problems (immunoglobulin A deficiency, monoclonal gammopathies), diabetes, high blood pressure, high blood fats (triglycerides), migraines, current blood infection (sepsis), kidney disease, severe loss of body fluids (dehydration).

Some immune globulin products are made with maltose. This substance can cause false high blood sugar levels when your blood sugar is normal or even low. If you have diabetes, check with your pharmacist whether the product you are using contains maltose and whether your blood sugar testing supplies will work with this product. Rarely, serious problems have occurred when too much insulin was given because of false high sugar readings or when low blood sugar went untreated.

Tell your doctor of any recent/planned vaccinations. This medication may prevent a good response to live viral vaccines (e.g., measles, mumps, German measles). If you are vaccinated less than 14 days before receiving this medication or during the 11 months after receiving this medication, you may need to be vaccinated again or tested to see whether the vaccine was effective.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the kidneys.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Gammagard Patient Information Including Side Effects

Brand Names: Carimune, Flebogamma, Gamimune N 10%, Gammagard, Gammagard S/D, Gammar-P I.V., Gamunex, Iveegam En, Octagam, Panglobulin NF, Polygam S/D, Privigen, Sandoglobulin

Generic Name: immune globulin (intravenous) (IGIV) (Pronunciation: im MYOON GLOB yoo lin)

  • What is immune globulin (Gammagard)?
  • What are the possible side effects of immune globulin?
  • What is the most important information I should know about immune globulin?
  • What should I discuss with my health care provider before using immune globulin?
  • How is immune globulin given?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using immune globulin?
  • What other drugs will affect immune globulin?
  • Where can I get more information?

What is immune globulin (Gammagard)?

Immune globulin intravenous is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

Immune globulin is used to treat primary immune deficiency, and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

Immune globulin is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

Immune globulin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of immune globulin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • trouble breathing, blue lips;
  • fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Less serious side effects may include:

  • headache;
  • dizziness;
  • upset stomach, mild nausea, vomiting, diarrhea;
  • back pain, joint pain, minor chest pain;
  • mild itching or skin rash; or
  • runny or stuffy nose, cough, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about immune globulin?

Immune globulin can be harmful to the kidneys, and these effects are increased when immune globulin is used together with other medicines that can harm the kidneys. Before using immune globulin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before you use immune globulin intravenous, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure this medication is helping your condition and is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be checked. Do not miss any scheduled appointments.

Using immune globulin can cause you to have unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.

Immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although immune globulin is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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