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

Manufacture: Baxalta
Country: Canada
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Idiopathic Thrombocytopenic Purpura, Multifocal Motor Neuropathy, Primary Immunodeficiency Syndrome
Class: Immune globulins
Form: Liquid solution, Intravenous (IV)
Ingredients: human normal immunoglobulin, glycine, water for injections

GAMMAGARD LIQUID

Immune Globulin Intravenous (Human), [IGIV] 10%

About this Medication

What is GAMMAGARD LIQUID used for

GAMMAGARD LIQUID is used for the following:

  • Primary immunodeficiency

    Replacement therapy in primary immunodeficiency syndromes (PID) such as:

    • Congenital agammaglobulinaemia and hypogammaglobulinaemia
    • Common variable immunodeficiency
    • Severe combined immunodeficiency
    • Wiskott Aldrich syndrome
  • Secondary Immunodeficiency

    Replacement therapy in secondary immunodeficiency syndromes (SID) such as:

    • B-cell chronic lymphocytic leukemia
    • Pediatric HIV infection
    • Allogeneic bone marrow transplantation
  • Idiopathic thrombocytopenic purpura (ITP)
  • Multifocal Motor Neuropahty (MMN)
    • Maintenance therapy to improve muscle strength and disability in adult patients with MMN.

How does GAMMAGARD LIQUID work

GAMMAGARD LIQUID 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 LIQUID if

GAMMAGARD LIQUID must not be used

  • If you are hypersensitive (allergic) to immunoglobulins or to the other ingredient of GAMMAGARD LIQUID.
  • If you have an immunoglobulin A deficiency (lack of IgA antibodies), you may have antibodies against immunoglobulin A in your blood. Since GAMMAGARD LIQUID contains small amounts of immunoglobulin A (average concentration of 37 mcg/mL), you might develop an allergic reaction.

What are the ingredients in GAMMAGARD LIQUID

The active substance is human normal immunoglobulin

GAMMAGARD LIQUID contains 10% (100 mg/mL) of human protein of which at least 98% is immunoglobulin G (IgG). The other ingredients are glycine and water for injections.

GAMMAGARD LIQUID is a 10 % solution (100 mg/mL) for intravenous infusion. The solution is clear or slightly opalescent and colorless or pale yellow.

What the important nonmedicinal ingredients are

The other ingredients are glycine and water for injections.

GAMMAGARD LIQUID comes in the following dosage forms

GAMMAGARD LIQUID is available in packages of 1 g in 10 mL, 2.5 g in 25 mL, 5 g in 50 mL, 10 g in 100 mL, 20 g in 200 mL and 30 g in 300 mL pack sizes.

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
  • Thromboembolic 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.

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.

GAMMAGARD LIQUID does NOT contain sucrose.

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

Interactions

  • Please inform your healthcare provider 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 LIQUID 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 LIQUID contains a wide variety of different antibodies, some of which can affect blood tests. If you have a blood test after receiving GAMMAGARD LIQUID, please inform the person taking your blood or your doctor about your infusion.

Proper Use

Usual dose

GAMMAGARD LIQUID 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. The following instructions are to help your doctor administer the best dose for you.

Table III-1 Recommended Dose and Dosage Adjustment
Indication Dose Frequency of Injections
Replacement therapy in primary immunodeficiency - starting dose:
0.4 – 0.8 g/kg BW
every 2 – 4 weeks to obtain IgG
trough level of at least 4 – 6 g/L
- thereafter:
0.2 – 0.8 g/kg BW
Replacement therapy in secondary immunodeficiency
Allogeneic bone marrow Transplantation 0.2 – 0.4 g/kg BW every 3 – 4 weeks to obtain IgG
trough level of at least 4 – 6 g/L
Treatment of infections and prophylaxis of graft-versus host disease 0.5 g/kg every week from day -7 up to 3 months after transplantation
Persistent lack of antibody production 0.5 g/kg every month until antibody levels return to normal
Idiopathic thrombocytopenic purpura 0.8 – 1 g/kg BW
or
0.4 g/kg BW/d
on day 1, possibly repeated once
within 3 days
for 2 – 5 days
Multifocal Motor Neuropathy (MMN) 0.5 – 2.4 g/kg every month based on clinical response

BW - bodyweight d day

At the beginning of your infusion you will receive GAMMAGARD LIQUID at a slow rate (0.5 mL/kg of bodyweight/hour for 30 minutes). 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.

For treatment of Multifocal Motor Neuropathy (MMN), Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 mL/kg BW/hr. If well tolerated, the rate of administration may gradually be increased to a maximum rate of 5.4 mL/kg BW/hr.

Overdose

If you receive more GAMMAGARD LIQUID 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.

If you have taken too much GAMMAGARD LIQUID, contact your healthcare provider, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Take GAMMAGARD LIQUID at the earliest available opportunity.

Side Effects

What are possible side effects from using GAMMAGARD LIQUID?

These are not all the possible side effects you may feel when taking GAMMAGARD LIQUID. If you experience any side effects not listed here, contact your healthcare professional. Like all medicines, GAMMAGARD LIQUID 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

Talk with your doctor or pharmacist Stop taking drug and call
your doctor
Only if severe In all cases
Anaphylactic Shock
Common
Uncommon
Rare
Very rare
Renal insufficiency
Common
Uncommon
Rare
Very rare
Reversible aseptic meningitis
Common
Uncommon
Rare
Very rare
Thromboembolic events (blood clots)
Common
Uncommon
Rare
Very rare

This is not a complete list of side effects. For any unexpected effects while taking GAMMAGARD LIQUID contact your healthcare professional.

How to Store it

Keep out of the reach and sight of children.

Refrigeration storage: Store in a refrigerator (2°C – 8°C) for up to 36 months.

Room temperature storage: Within the first 24 months from the date of manufacture, GAMMAGARD LIQUID may be stored for a single period of up to 12 months at room temperature (below 25° C). After this period, unused product must be discarded. See below the detailed storage information.

The total storage time of GAMMAGARD LIQUID depends on the point of the time the vial is transferred to room temperature. Examples for storage times are illustrated in Figure 1. If GAMMAGARD LIQUID is stored at room temperature (below 25° C), the date on which carton is removed from refrigerated storage and the new expiry date must be recorded in the area provided on the carton.

The new expiry date will be the shorter of: 24 months from the date of manufacture (indicated on the carton); or 12 months from the date removed from refrigeration. Once removed from refrigeration and stored at room temperature GAMMAGARD LIQUID must be used or discarded and may not be returned to refrigerated storage.”

Figure 1 Stability Guidelines for GAMMAGARD LIQUID

Date of Manufacture


Example: If the product is taken out of the refrigerator after 3 months, it can be stored for 12 months at room temperature, and the total storage time is 15 months.

Do not freeze.

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

Keep the container in the outer carton in order to protect from light.

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.hcsc.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 LIQUID:

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.