What Gammagard SD is used for and how to use it
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Gammagard SD - Consumer Medicine Information

Manufacture: Baxalta
Country: Canada
Condition: Autoimmune Neutropenia, Bone Marrow Transplantation, Chronic Lymphocytic Leukemia, Evan's Syndrome, Idiopathic Thrombocytopenic Purpura, Kawasaki Disease (Mucocutaneous Lymph Node Syndrome), Primary Immunodeficiency Syndrome
Class: Immune globulins
Form: Liquid solution, Intravenous (IV)
Ingredients: human normal immunoglobulin

Immune Globulin Intravenous (Human), [IGIV]

About this medication

What is GAMMAGARD S/D used for?

GAMMAGARD S/D is used for the following:

Replacement therapy in

  • Primary immunodeficiency syndromes (PID) Including:
    • Congenital agammaglobulinaemia and hypogammaglobulinaemia
    • Common variable immunodeficiency
    • Wiskott Aldrich syndrome
    • Severe combined immunodeficiency
  • B-cell Chronic Lymphocytic Leukemia (CLL)
  • Idiopathic thrombocytopenic purpura (ITP)

How does GAMMAGARD S/D work?

GAMMAGARD S/D belongs to a class of medicines called immunoglobulins. These medicines contain human antibodies, which are also present in your blood. Antibodies help your body to fight infections. Immunoglobulins are used in patients who do not have enough antibodies in their blood and tend to get frequent infections. They can also be used in patients who need additional antibodies for the treatment of certain inflammatory disorders.

Do not use GAMMAGARD S/D if

GAMMAGARD S/D must not be used

  • If you are hypersensitive (allergic) to immunoglobulins or to the other ingredient of GAMMAGARD S/D.
  • If you have an immunoglobulin A deficiency (lack of IgA antibodies), you may have antibodies against immunoglobulin A in your blood. Since GAMMAGARD S/D contains small amounts of immunoglobulin A (≤2 µg/mL in a 5% solution), you might develop an allergic reaction.

What are the ingredients in GAMMAGARD S/D?

The active substance is human normal immunoglobulin.

GAMMAGARD S/D may be reconstituted with diluent (Water for Injection, USP) to a 5% (50 mg/mL) solution or a 10% (100 mg/mL) solution of protein of which at least 90% is gamma globulin.

What the important nonmedicinal ingredients in GAMMAGARD S/D are

The other ingredients are:

  • Albumin (Human)
  • Glycine
  • Dextrose
  • Polyethylene glycol (PEG)
  • Tri(n-butyl) phosphate
  • Octoxynol 9
  • Polysorbate 80

GAMMAGARD S/D comes in the following dosage forms

GAMMAGARD S/D is available in 2.5 g/vial, 5 g/vial and 10 g/vial size vials of freeze-dried concentrate, which is packaged with Sterile Water for Injection, USP (diluent), a transfer device, and an administration set.

Warnings and precautions

Serious Warnings and Precautions

Immune Globulin Intravenous (IGIV) products have been reported to cause: —Disease of the kidneys
—Failure of the kidneys
—Damage to the tubes inside of the kidneys
—Thrombotic events
—Death

People with an increased risk of kidney damage include those with any degree of existing kidney disease, diabetes, age greater than 65, dehydrated, have an overwhelming infection, have abnormal proteins in their blood, or patients receiving drugs known to damage the kidneys. Especially in these people, IGIV products should be administered at the lowest possible concentration and as slowly as is practical. While these reports of kidney disease and failure of the kidneys have been associated with the use of many of the licensed IGIV products, those containing sucrose produced more kidney problems than expected.

GAMMAGARD S/D does NOT contain sucrose.

People with increased risk to blood clots in their veins or arteries include those that have high blood pressure, diabetes mellitus, history of blood vessel disease or previous clots, acquired or inherited increased numbers or activity of platelets which help the blood clot, prolonged periods of not moving, such as lying in bed, increased activity of the proteins that make blood clot, conditions, obesity, advanced age, use of estrogens, long term catheters that go into a central vein, and other cardiovascular risk factors.

Thrombosis may occur even in the absence of known risk factors.

You should discuss the risks and benefits of this product with your healthcare provider.

Interactions

  • Please inform your healthcare professional if you are taking, or have recently taken any other medicines, even those not prescribed, or if you have received a vaccination during the last six weeks.
  • Infusion of immunoglobulins like GAMMAGARD S/D may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox vaccines. Therefore, after receiving immunoglobulins you may have to wait up to 3 months before receiving your liveattenuated vaccine. You may have to wait for up to 1 year after receiving immunoglobulins before you receive your measles vaccine.
  • GAMMAGARD S/D contains a wide variety of different antibodies, some of which can affect blood tests. If you have a blood test after receiving GAMMAGARD S/D, please inform the person taking your blood or your doctor about your infusion.

How to take GAMMAGARD S/D

Usual dose

GAMMAGARD S/D is intended for intravenous administration (infusion into a vein). It is given to you by your doctor. Dosage will vary depending on your condition and your bodyweight.

At the beginning of your infusion you will receive GAMMAGARD S/D at a slow rate (0.5 mL/kg of bodyweight/hour). Depending on how comfortable you are your doctor may then gradually increase the infusion rate to a maximum of 8 mL/kg of bodyweight/hour.

This product is latex free.

Overdose

If you receive more GAMMAGARD S/D than you should, your blood may become too thick (hyper-viscous). This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys.

If you think you have taken too much GAMMAGARD S/D, contact your healthcare professional, hospital emergency department or the regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Take GAMMAGARD S/D at the earliest available opportunity.

Side effects

What are the possible side effects from using GAMMAGARD S/D?

These are not all the possible side effects you may feel when taking GAMMAGARD S/D. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions. Like all medicines, GAMMAGARD S/D can have side effects.

However, possible side effects may be reduced by slowing the infusion rate.

  • General reactions such as chills, headaches, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure and moderate lower back pain have been experienced occasionally.
  • Rarely, cases of a sudden fall in blood pressure were observed, and in isolated cases allergic reactions (anaphylactic shock), even in patients who have shown no reactions to previous infusions. Symptoms for an immediate allergic reaction are bronchitis or asthma, flu-like symptoms, pink eye, generalized rash, skin oedema (angiooedema), dizziness and collapse.
  • Cases of temporary meningitis (reversible aseptic meningitis), isolated cases of temporary decrease of red blood cells (reversible haemolytic anaemia/haemolysis) and rare cases of eczema-like symptoms (transient cutaneous reactions) have been observed with immunoglobulin products.
  • An increase in blood creatinine content and kidne y failure has also been observed.
  • Very rarely, cases of blood clot formation in the veins (thromboembolic reactions) resulting in cardiac infarction, stroke, lung embolism, and deep vein thrombosis have been reported.
  • If you notice any side effects not mentioned in t his leaflet, please inform your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them

Anaphylactic ShockTalk with your doctor
or pharmacist S
Stop taking drug and call
your doctor or pharmacist
Only if severe IIn all cases
Common
Uncommon
Rare
Very rare
Renal insufficiencyTalk with your doctor
or pharmacist S
Stop taking drug and call
your doctor or pharmacist
Only if severe IIn all cases
Common
Uncommon
Rare
Very rare
Reversible aseptic meningitisTalk with your doctor
or pharmacist S
Stop taking drug and call
your doctor or pharmacist
Only if severe IIn all cases
Common
Uncommon
Rare
Very rare
Thromboembolic events
(blood clots)
Talk with your doctor
or pharmacist S
Stop taking drug and call
your doctor or pharmacist
Only if severe IIn all cases
Common
Uncommon
Rare
Very rare

Storage

GAMMAGARD S/D, is to be stored at a temperature not to exceed 25°C (77°F). Freezing should be avoided to prevent the diluent vial from breaking. Do not use after the expiration date.

Any unused solution must be discarded due to the risk of bacterial contamination. Store out of reach and sight of children.

Do not use after the expiry date stated on the label.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
                     Health Canada
                     Postal Locator 0701D
                     Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at http://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about GAMMAGARD S/D

This document plus the full product monograph, prepared for health professionals can be found at: TBD

Or by calling the sponsor, Baxalta Canada Corporation at: 1-800-387-8399 This leaflet was prepared by Baxalta Canada Corporation