Patient Medication Information: uses, side effects, how to take - Gammagard S/D (IV)
ABOUT THIS MEDICATION
What the medication is 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)
What it does:
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.
When it should not be used:
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 (≤2.2 μg/mL in a 5% solution), you might develop an allergic reaction.
What the medicinal ingredient is:
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 are:
The other ingredients are:
- Albumin (Human)
- Glycine
- Dextrose
- Polyethylene glycol (PEG)
- Tri(n-butyl) phosphate
- Octoxynol 9
Polysorbate 80
What dosage forms it comes in:
GAMMAGARD S/D is available in 0.5 g/vial, 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
- 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 containin sucrose produced more kidney problems than expected.
Gammagard S/D does NOT contain sucrose.
You should discuss the risks and benefits of this product with your physician.
INTERACTIONS WITH THIS MEDICATION
- Please inform your doctor 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 live-attenuated 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.
PROPER USE OF THIS MEDICATION
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.
Overdose:
If you receive more GAMMAGARD S/D than you should, your blood may become too thick (hyperviscose). This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys.
In case of drug overdose, contact 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 AND WHAT TO DO ABOUT THEM
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 kidney 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 this leaflet, please inform your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Anaphylactic Shock | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | ||||
| Uncommon | ||||
| Rare | ✔ | ✔ | ✔ | |
| Very rare | ||||
| Renal insufficiency | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | ||||
| Uncommon | ||||
| Rare | ✔ | ✔ | ✔ | |
| Very rare | ||||
| Reversible aseptic meningitis | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | ||||
| Uncommon | ||||
| Rare | ✔ | ✔ | ✔ | |
| Very rare | ||||
| Thromboembolic events | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
| Common | ||||
| Uncommon | ||||
| Rare | ✔ | ✔ | ✔ | |
| Very rare | ||||
This is not a complete list of side effects. For any unexpected effects while taking GAMMAGARD S/D contact your doctor or pharmacist.
HOW TO STORE IT
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 of children.
Do not use after the expiry date stated on the label.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: http://www.baxter.com
Or by calling the sponsor, Baxter Corporation at: 1-800-387-8399
Last revised: February 2013
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, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form 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.