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GAMMAGARD S/D 10G POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): IMMUNOGLOBULIN NORMAL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GAMMAGARD S/D 5.0 g / 10.0
Powder and solvent for solution for infusion
Human normal immunoglobulin

Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What GAMMAGARD S/D is and what it is used for
2. Before you use GAMMAGARD S/D
3. How to use GAMMAGARD S/D
4. Possible side effects
5. How to store GAMMAGARD S/D
6. Further information

1. WHAT GAMMAGARD S/D IS AND WHAT IT IS USED FOR

GAMMAGARD S/D belongs to a class of medications called immunoglobulins. These medicines contain human antibodies, which are present in human
blood. Antibodies help your body to fight infections. Medicines like GAMMAGARD S/D are used if you do do not have enough antibodies in your blood.
These patients tend to get frequent infections. GAMMAGARD S/D can also be used if you need additional antibodies to cure certain inflammatory disorders
(autoimmune diseases).
GAMMAGARD S/D is used for

Treatment of patients who do not have sufficient antibodies (replacement therapy). There are four groups:
1. Patients with inborn lack of antibodies (primary immunodeficiency syndromes (PID)) such as:
- congenital agammaglobulinemia or hypogammaglobulinemia
- common variable immunodeficiency
- severe combined immunodeficiencies
- Wiskott Aldrich syndrome
2. Patients with a lack of antibody production and recurrent infections (myeloma or chronic lymphocytic leukaemia with severe secondary
hypogammaglobulinemia)
3. Children who suffer from inborn AIDS and get frequent infections
4. Premature children with low birth weight with a risk for getting infections.

Treatment of patients with certain inflammatory disorders (immunomodulation). There are three groups:
1. Patients who do not have enough blood platelets (idiopathic thrombocytopenic purpura, ITP). These patients may have a high risk of bleeding.
2. Patients with a disease that is associated with multiple inflammations of the nerves in the whole body (Guillain Barré syndrome)
3. Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease)
Treatment or prevention of infections after a bone marrow transplantation (allogeneic bone marrow transplantation)

2. BEFORE YOU ARE GIVEN GAMMAGARD S/D
Do NOT use GAMMAGARD S/D

You MUST NOT use GAMMAGARD S/D
- if you are allergic (ranging from hypersensitivity to life threatening allergic shock) to immunoglobulins or any of the other ingredients of GAMMAGARD S/D.
For other ingredients please refer to section 6. FURTHER INFORMATION.
- if you have an immunoglobulin A deficiency. You may have antibodies against immunoglobulin A in your blood. However, GAMMAGARD S/D contains only
very small amounts of immunoglobulin A (less than 3 micrograms/mL in a 5% solution).

Take special care with GAMMAGARD S/D

How long monitoring is required during the infusion
- You will be carefully observed during the infusion period with GAMMAGARD S/D. Your doctor will make sure that the rate at which GAMMAGARD S/D is
infused is suitable for you.
- There may be a higher risk of side effects
- if GAMMAGARD S/D is administered at a fast rate,
- if you suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia),
- if you have not received this medicine before or
- if there has been a long interval (e.g. several weeks) since you last received it.
In such cases, you will be closely monitored during your infusion and for an hour after your infusion has stopped.
- If you have already received GAMMAGARD S/D recently, you will only be observed during and for at least 20 minutes after your infusion.

When slowing or stopping the infusion may be required
- In rare cases your body will be sensitive to medicines containing antibodies. This may happen particularly if you suffer from immunoglobulin A deficiency.
In these rare cases, you may get allergic reactions such as a sudden fall in blood pressure or shock.
- If you develop any of the following side effects you must tell your doctor or nurse immediately:
- Sudden wheeziness, difficulty in breathing or tightness of the chest
- Headache
- Fever
- Swelling of the eyelids, face, lips or blood vessels
- Skin lumps or itchy red spots
- Itch all over the body.
Depending on your doctor’s decision the rate of infusion can be slowed or the infusion can be stopped.

Special patient groups
- Your doctor will take special care if you are overweight, elderly, diabetic, or immobilized. Your doctor will observe you closely if you:
- suffer from high blood pressure
- low blood volume (hypovolaemia)
- increase in blood viscosity or from problems with your blood vessels (vascular diseases).
In these conditions, immunoglobulins may increase the risk of heart attack, stroke, lung embolism, or deep vein thrombosis.
- Your doctor will also take special care
- if you have or had previously problems with your kidneys, or
- if you receive medicinal products that may harm your kidney (nephrotoxic medicinal products), as there is a very rare chance of acute kidney failure.
Please tell your doctor if you have a kidney disorder.

Information on the source material of GAMMAGARD S/D

GAMMAGARD S/D is made from human plasma (the liquid part of blood). When medicines are made from human blood or plasma, a number of measures
are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of
carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also
include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human
blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or
other types of infections.

- Isolated cases of temporary reduction of red blood cell count (reversible haemolytic anaemia/haemolysis),
- Transient increases in liver function values (liver transaminases), an increase in blood creatinine content and kidney failure,
- Blood clot formation in the veins (thromboembolic reactions), which may lead to heart attack, stroke, lung injury (pulmonary embolism), and deep vein
thrombosis.

Below is a list of side effects that some patients reported when GAMMAGARD S/D was tested in clinical trials and side effects reported during post-market
phase:
• Common side effects (seen in less than 1 in every 10 patients):
- headache,
- flushing,
- nausea, vomiting,
- fatigue, chills, fever,
Uncommon side effects (seen in less than 1 in every 100 patients):
- anxiety, agitation, abnormal drowsiness,
- blurred vision,
- sensation of irregular beating of the heart,
- shortness of breath,
- nose bleed,
- diarrhoea, stomach pain/discomfort,
- inflammation in the mouth,
- itching, hives,
- cold sweat, excessive sweating
- back pain, muscle cramp, pain in extremity, chest pain, chest discomfort,
- feeling abnormal, feeling cold, feeling hot, flu-like illness,
- infusion site redness, leaking at infusion site, infusion site pain, feeling or being sick, pain,
- high blood pressure, blood pressure fluctuation,
- loss of appetite.

Other side effects include:
- Inflammation of brain membranes not caused by a bacterial infection
- destruction of red blood cells, decreased number of red blood cells, decreased number of blood platelets
- swollen lymph nodes
- all severity degrees of allergic reactions including allergic shock, restlessness, dizziness, abnormal skin sensation,
- involuntary trembling,
- seizures, bleeding in the brain, (transient) stroke, migraine, loss of consciousness, dislike of light,
- visual disturbance
- heart attack, bluish colour of the skin, increased heart rate, reduced heart rate, high blood pressure, paleness, low blood pressure, inflammation of veins,
occlusion of blood vessels, reduced - oxygen level in blood,
- cough, throat tightness
- overbreathing,
- wheezing, airway spasm, occlusion of blood vessels in the lung, fluid in the lung,
- disturbed digestion, abdominal pain,
- inflammation of the liver (not transmissible)
- redness of the skin, skin eruptions, inflammation of the skin
- allergic swelling of deep skin layers,
- joint and muscle pain
- failure of the kidney
- general weakness
- swelling of body tissue,
- injection and infusion site reactions,
- chills,
- positive result of Coombs test
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW GAMMAGARD S/D IS STORED
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Keep out of the reach and sight of children.
Do not use GAMMAGARD S/D after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not freeze.
Keep the container in the outer carton in order to protect from light.

6. FURTHER INFORMATION
What GAMMAGARD S/D contains
- The active substance of GAMMAGARD S/D is human normal immunoglobulin.
GAMMAGARD S/D may be reconstituted with Sterilized Water for Injections to a 5% (50 mg/mL) solution or a 10% (100 mg/mL) solution of protein.
At least 90 % of the protein is immunoglobulin G (IgG).
- The other ingredients are human albumin, glycine, sodium chloride and glucose monohydrate.
What GAMMAGARD S/D looks like and contents of the pack

GAMMAGARD S/D is a freeze-dried, white or very faint yellow powder. GAMMAGARD S/D is available in pack sizes of 5.0 g, and 10.0 g.
GAMMAGARD S/D 5.0 g, and 10.0 g: Each package contains
- a 5.0 g or 10.0 g powder vial,
- 96 mL or 192 mL of Sterilized Water for Injections,
- a sterile transfer device and
- a sterile administration set with filter.
Marketing Authorisation Holder and Manufacturer
MA holder: Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Vienna,
Austria


Tel. 01635 798 777

Manufacturer: Baxalta Belgium Manufacturing S.A., B-7860, Lessines, Belgium.
This leaflet was last approved in July 2015

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY
Special Precautions for Storage

When reconstitution is performed aseptically outside of a sterile laminar airflow hood, administration should begin as soon as possible, but not more than
2 hours after reconstitution. When reconstitution is performed aseptically in a sterile laminar airflow hood, the reconstituted product may be stored under
constant refrigeration (2-8°C), for up to 24 hours. If these conditions are not met, sterility of the reconstituted product cannot be maintained. Partially used
vials should be discarded.
Reconstitution - use aseptic technique:

The measures taken for the manufacture of GAMMAGARD S/D are considered effective for enveloped viruses such as human immunodeficiency virus (HIV),
hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus and parvovirus B19. GAMMAGARD S/D also contains certain antibodies
that can prevent an infection with hepatitis A virus and parvovirus B19.
Taking other medicines
- Please tell your doctor
- if you are taking any other medicines, including medicines obtained without a prescription, or
- if you have received a vaccination during the last six weeks.
- GAMMAGARD S/D may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox. Therefore, after receiving
these medicines you may have to wait up to 3 months before receiving your live virus vaccine. You may have to wait for up to 1 year after receiving
immunoglobulins before you receive your measles vaccine.

Effects on blood tests

GAMMAGARD S/D contains a wide variety of different antibodies, some of which can affect blood tests. If you have a blood test, please inform the person
taking your blood that you have received GAMMAGARD S/D.

Pregnancy and breast-feeding
- Please inform your doctor if you are pregnant or breast-feeding. Your doctor will decide if GAMMAGARD S/D may be used during pregnancy and breastfeeding.
- No clinical trials have been made with GAMMAGARD S/D in pregnant or breast-feeding women. Years of clinical experience with medicines containing
antibodies indicate that no harmful effects on the course of pregnancy or the baby are to be expected.
- If you are breast-feeding, the antibodies of GAMMAGARD S/D can be found in the breast milk. Therefore, your baby may be protected from certain
infections.

Driving and using machines

GAMMAGARD S/D has no influence on your ability to drive or use machines.

Important information about some of the ingredients of GAMMAGARD S/D

Tell your doctor if you are diabetic. GAMMAGARD S/D contains sugar (glucose), which could affect your blood sugar level.

3. HOW GAMMAGARD S/D IS GIVEN

GAMMAGARD S/D is intended for intravenous administration (infusion into a vein). It is given to you by your doctor or nurse. Dosage will vary depending on
your condition and your body weight.
At the beginning of your infusion you will receive GAMMAGARD S/D at a slow rate. Dependent on how comfortable you are, your doctor may then gradually
increase the infusion rate.
If you are given more GAMMAGARD S/D than you should

If you get more GAMMAGARD S/D than you should, your blood may become too thick (hyperviscous). The thicker the blood becomes, the more difficultly
will it move in the vessels of your body. As a result, there will be less oxygen transferred to the vital organs, such as brain, lungs, etc. This could particularly
happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys.

4. POSSIBLE SIDE EFFECTS

Like all medicines, GAMMAGARD S/D can cause side effects, although not everybody gets them.

The following side effects may generally occur after treatment with immunoglobulins (medicines like GAMMAGARD S/D):
• Common or uncommon side effects (which occur in less than 1 in every 10, but more than 1 in every 1.000 patients) are chills, headache, fever, vomiting,
allergic reactions, nausea, joint pain, low blood pressure and moderate lower back pain.
• Rare side effects, which occur less than 1 in every 1.000 patients, are:
- Cases of a sudden fall in blood pressure,
- Eczema-like symptoms (transient cutaneous reactions).
• Very rare side effects, which occur in less than 1 in every 10.000 patients or cannot be estimated from available data, are
- Isolated cases of allergic reactions (anaphylactic shock), even if you have shown no reactions to previous infusions,
- Cases of temporary brain fever (reversible aseptic meningitis),

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5.0 g, 10.0 g Sizes

Bring GAMMAGARD S/D and Sterilized Water for Injections (solvent) to room temperature. This temperature needs to be maintained until dissolution is
complete.
A. 5% Solution:
1. Remove bottle caps and clean stoppers with germicidal solution.
2. Remove spike cap from one end of the transfer device. Do not touch spike.

2

Solvent

Concentrate

3a. Place the solvent vial on a flat surface. Use exposed end of transfer device to spike solvent vial through center of the
stopper.
Caution: Failure to insert spike into center of the stopper may result in dislodging of the stopper.

3a

Solvent

3b. Ensure that the collar collapses fully into the device by pushing down on the transfer device firmly.
While holding onto transfer device, remove remaining spike cover. Do not touch spike.

4. Hold solvent bottle with attached transfer device at an angle to the concentrate bottle to
prevent spilling the solvent.
Note: Do not hold solvent bottle upside down, for this can lead to solvent spillage.

3b

4
Concentrate

Solvent
Concentrate

5a. Spike concentrate bottle through the center of the stopper while quickly inverting the solvent vial to avoid spilling out
solvent.
CAUTION: Failure to insert the spike into the center of the stopper may result in dislodging of the stopper and
loss of vacuum.

Solvent

5a

Solvent

Concentrate

5b. Ensure that the collar collapses fully into the device by pushing down on the solvent bottle firmly.

Press Firmly

6. After transfer of solvent is complete, remove transfer device and empty solvent bottle. Immediately swirl the concentrate
bottle gently to thoroughly mix contents.
CAUTION: Do not shake. Avoid foaming.
Discard transfer device after single use.

5b

6

B. 10% Solution:
1. Remove bottle caps and clean stoppers with germicidal solution.
2. To prepare a 10% solution, it is necessary to remove half of the volume of solvent. Table 2 indicates the volume of solvent that should be removed from
the vial before attaching the transfer device to produce a 10% concentration. Using aseptic technique, withdraw the unnecessary volume of solvent using
a sterile hypodermic syringe and needle. Discard the filled syringe and needle.
3. Using the residual solvent in the solvent vial, follow steps 2-6 as previously described in A.
TABLE 2

Concentration
5%
10%

Required Solvent Volume to be Removed
5.0 g bottle
Do not remove any solvent for reconstitution of 5% Solution
48 mL

10.0 g bottle
96 mL

Administration - use aseptic technique
5.0 g, 10.0 g Sizes

Follow the direction insert for use, which accompanies the administration set provided in each package. If another administration set is used, ensure that the
set contains a similar filter.
Instructions for Handling and Disposal
- Total dissolution should be obtained within 30 minutes.
- The product should be brought to room or body temperature before use.
- Reconstituted material should be a clear to slightly opalescent and colourless to pale yellow solution. Do not use solutions that are cloudy or have
deposits. Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.
- Any unused product or waste material should be disposed of in accordance with local requirements.
Method of Administration

GAMMAGARD S/D 5% (50 mg/mL) should be infused intravenously at an initial rate of 0.5 mL/kg body weight (BW)/hour. If well tolerated, the rate of
administration may gradually be increased to a maximum of 4 mL/kg BW/hour. Patients who tolerate GAMMAGARD S/D 5% solutions at 4 mL/kg BW/hour
can be infused with the 10% concentration starting at 0.5 mL/kg BW/hour. If no adverse effects occur, the rate can be increased gradually up to a maximum
rate of 8 mL/kg BW/hour.
Special Precautions
- Any infusion-related adverse events should be treated by lowering the infusion rate or by stopping the infusion.
- It is recommended that every time GAMMAGARD S/D is administered, the name and batch number of the product is recorded.
Incompatibilities

GAMMAGARD S/D must not be mixed with other medicinal products.

It is recommended that GAMMAGARD S/D be administered separately from other medicinal products that the patient may be receiving.
Dosage Recommendations

Indication
Replacement therapy in primary immunodeficiency

Dose

Frequency of Injections

- starting dose:
0.4 – 0.8 g/kg BW
- thereafter:
0.2 – 0.8 g/kg BW

every 2 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/L

Replacement therapy in secondary immunodeficiency

0.2 – 0.4 g/kg BW

every 3 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/L

Children with AIDS

0.2– 0.4 g/kg BW

every 3 - 4 weeks

Premature children with low birth weight
(neonates aged less than 7 days)

0.5 g/kg BW

two injections one week apart, followed by a total of 5 infusions
every 14 days or until discharge from hospital

Immunomodulation:
Idiopathic thrombocytopenic purpura

0.8 – 1 g/kg BW
or

on day 1, possibly repeated once within 3 days

0.4 g/kg BW/day

for 2 – 5 days

Guillain Barré syndrome

0.4 g/kg BW/day

for 5 consecutive days

Kawasaki disease

1.6 – 2 g/kg BW
or

in several doses for 2 – 5 days in association with acetylsalicylic
acid

2 g/kg BW

in one dose in association with acetylsalicylic acid

Allogeneic bone marrow transplantation:
- Treatment of infections and prophylaxis of graft versus
host disease

0.5 g/kg BW

every week from day –7 up to 3 months after transplantation

- Persistent lack of antibody production

0.5 g/kg BW

every month until antibody levels return to normal



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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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