GAMMAPLEX 10% 100 MG / ML SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

1. what gammaplex 10% is and what it is used for

Gammaplex 10% contains the active substance human normal immunoglobulin. The immunoglobulin contains antibodies which help to fight infection. Immunoglobulin is obtained from blood plasma from screened donors.

This medicine is used to treat patients who do not have sufficient antibodies (proteins which protect you against infection).

Gammaplex 10% is used to treat patients who require antibody replacement because they were born with an inability to produce antibodies (primary immunodeficien­cies).

Gammaplex 10% is also used to replace antibodies in secondary immunodeficiencies with severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or low serum immunoglobulin G level.

Gammaplex 10% is also used for the treatment of certain inflammatory disorders:

• – Primary immune thrombocytopenia (ITP, a blood platelet disorder), in patients at high risk of bleeding or requiring surgery

• – Kawasaki disease (an acute disorder of the blood vessels and heart in children)

• – Guillain Barre syndrome (an acute disorder of the peripheral nerves)

• – Chronic inflammatory demyelinating polyradiculone­uropathy (CIDP, a nervous system disorder)

• – Multifocal motor neuropathy (MMN, progressive dysfunction of the peripheral nerves, typically causing numbness or weakness).

Gammaplex 10% is used to treat adults, children and adolescents (aged 0–18 years).

2. what you need to know before you use gammaplex 10%

Read this section carefully. The information should be taken into consideration by you and your doctor before you are given Gammaplex 10%.

Do not use Gammaplex 10% if you:

• – are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in Section 6). If you do experience an allergic reaction, you may need immediate medical attention

• – have developed antibodies in your blood against immunoglobulins of the type IgA

Warnings and precautions

Talk to your doctor or nurse before using Gammaplex 10% if you:

• – are elderly – have high blood pressure

• – have a kidney disorder – have ever had a stroke, heart attack or other clotting complaint

• – have diabetes (now or in the past)

• – are overweight

You may need to be monitored more closely during treatment and the dose and speed of the infusion may have to be altered.

You will be monitored for the duration of the first infusion and for the first hour afterwards. With your next infusions you will be monitored for at least 20 minutes after your infusion.

The following information is intended for healthcare professionals only:

Gammaplex 10%

human normal immunoglobulin

Posology and method of administration

The dosage recommendations are summarised in the following table.

Indication	Dose	Frequency of injections
Replacement therapy
Primary immunodeficiency syndromes	Starting dose: 0.4 – 0.8 g/kg Maintenance dose: 0.2 – 0.8 g/kg	Every 3 – 4 weeks
Secondary Immunodeficiencies (as defined in section 4.1)	0.2 – 0.4 g/kg	Every 3 – 4 weeks
Immunomodulation
Primary immune thrombocytopenia	0.8 – 1 g/kg Or 0.4 g/kg/d	On day 1, possibly repeated once within 3 days For 2 – 5 days

With immunoglobulin treatments, you may get lung damage related to the treatment called Transfusion Related Acute Lung Injury (TRALI). If you get shortness of breath and find yourself having to breathe rapidly during or within several hours of your infusion, tell your doctor or nurse immediately as these symptoms may need urgent treatment.

Virus safety

When medicines are made from human blood or plasma, certain 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

• – the testing of each donation and pools of plasma for signs of virus/infections

• – the inclusion of 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 given, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections. The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A (HAV) and parvovirus B19 viruses. Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.

It is strongly recommended that the name and batch number of the medicine are recorded every time you receive a dose of Gammaplex 10% in order to maintain a record of the batches used.

Children and adolescents

The listed warnings and precautions for adults also apply to children and adolescents (aged 0–18 years).

Other medicines and Gammaplex 10%

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Vaccinations

Immunoglobulin infusions may interfere with immunisation with certain virus vaccines such as measles, rubella, mumps and varicella for a period of at least 6 weeks and up to 3 months. In the case of measles, this impairment may persist for up to a year. If you need a blood test during this period, tell your doctor when you last had an injection of Gammaplex 10%, as false positive results may occur with certain tests. This medicine will raise the level of various antibodies in your blood for several weeks or longer.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Some side effects of Gammaplex 10% may affect your ability to drive or operate machinery. Wait for side effects to resolve before you drive or operate machines.

Gammaplex 10% contains sodium

This medicine contains up to 0.005 mmol (0.115 mg) sodium per millilitre of solution. Therefore, according to the dose your doctor has advised, you will receive 0.23 – 2.3 mg sodium per kg of body weight. This range is equivalent to 0.12 – 1.2% of the recommended maximum daily dietary intake of sodium for an adult.

3. how to use gammaplex 10%

Gammaplex 10% is given by injection into a vein (intravenous infusion). It is given to you by your doctor, nurse or healthcare professional and you will be supervised by them. Your doctor will calculate how much to give you based on what you are being treated for, your weight and your response to treatment. At the beginning of the infusion you will be given Gammaplex 10% at a slow infusion rate as this may help to reduce possible side effects. If you tolerate the treatment well, your doctor can increase the infusion rate.

The infusion rate should be 0.3 ml/kg/hour for the first 15 minutes. If well tolerated, the infusion rate can be increased every 15 minutes (0.6, 1.2, 2.4, 3.6 ml/kg/hour) to a maximum of 4.8 ml/kg/hr. If you tolerate the first infusion well, the next infusion can start at 0.6 ml/kg/hour and then be increased as above.

If you receive more Gammaplex 10% than you should

It is unlikely that you will receive too much Gammaplex 10%. If you receive more Gammaplex 10% than you should, your blood may become too thick (hyperviscous). This may happen particularly if you are a patient at risk, for example if you are aged 65 years or older or if you suffer from kidney disease or suffer from heart problems. If you feel unwell afterwards or have any discomfort, tell your doctor or nurse.

Indication	Dose	Frequency of injections
Guillain Barre syndrome	0.4 g/kg/d	For 5 days
Kawasaki disease	2 g/kg	In one dose in association with acetylsalicylic acid
Chronic inflammatory demyelinating polyradiculone­uropathy (CID­P)	Starting dose: 2 g/kg Maintenance dose: 1 g/kg	In divided doses over 2 – 5 days Every 3 weeks over 1 – 2 days
Multifocal motor neuropathy (MMN)	Starting dose: 2 g/kg Maintenance dose: 1 g/kg Or 2 g/kg	Over 2 – 5 consecutive days Every 2 – 4 weeks Or Every 4 – 8 weeks over 2 – 5 days

If you forget to use Gammaplex 10%

Tell your doctor or nurse if you have missed a dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Gammaplex 10%

You should consult your doctor if you begin to feel unwell. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you feel unwell, tell your doctor immediately. Side effects may occur even if you have previously received human immunoglobulins and tolerated them well.

In isolated cases, you may experience a strong allergic reaction or a sudden drop in blood pressure.

Tell your doctor or nurse immediately if you find it difficult to breathe, if you feel dizzy and faint or if you develop swellings and a red itchy rash. Your doctor may want to slow down your treatment or stop it altogether and you may need additional treatment to correct your symptoms.

Rarely, you may also experience non-infectious inflammation of the brain or a skin rash that will go away in time.

Tell your doctor or nurse immediately if you feel ill with headaches, high temperature, neck stiffness, nausea and sickness, chills, generalised joint aches and pains or a rash during or within a few days after treatment. Your doctor may want to stop your treatment.

Depending on your blood group, you may be more susceptible to your blood being damaged while you are being treated. If this happens your doctor or nurse may want to increase your blood level with blood transfusions.

Increases in kidney values and kidney damage have been seen with this treatment. Your doctor may want to give you a lower treatment dose and slow down or stop your treatment if your kidneys are not working normally.

Very rarely, you may get an illness related to blood clotting. Blood clots can block the blood supply to parts of the body and can lead to serious illnesses that may require urgent treatment such as heart attacks or stroke. Tell your doctor or nurse immediately if you get any chest pain or breathlessness or signs of a stroke such as sudden weakness in your muscles or difficulty speaking. Tell your doctor or nurse if you develop a red, warm or tender swelling in your leg.

Method of administration

For intravenous use.

Human normal immunoglobulin should be infused intravenously at an initial rate of 0.3 ml/kg/hr for 15 minutes. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased (every 15 minutes as follows: 0.6, 1.2, 2.4, 3.6 ml/kg/hr) to a maximum of 4.8 ml/kg/hr; subsequent infusions can start at 0.6 ml/kg/hr and increased as above.

Special precautions

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction.

It is strongly recommended that every time that Gammaplex 10% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Additional side effects in children and adolescents

Side effects in children are expected to be the same as in adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store gammaplex 10%

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not freeze.

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

Do not use this medicine after the expiry date which is stated on the carton and vial label after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice that the solution is cloudy or has deposits.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat gammaplex 10% contains- the active substance is human normal immunoglobulin.

• – 1 ml of Gammaplex 10% contains 100 mg of human protein, of which at least 98% is immunoglobulin G (IgG).

• – The other ingredients (excipients) are glycine, polysorbate 80, water for injections.

looks like and contents of the pack

Gammaplex 10% is a clear or slightly pearl-like (opalescent) colourless to pale yellow liquid.

Gammaplex 10% is available in vials of 50 ml, 100 ml or 200 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bio Products Laboratory Ltd., Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom

Tel: +44 (0) 20 8957 2255

e-mail:

Manufacturer

Bio Products Laboratory Ltd., Dagger Lane, Elstree, Borehamwood, WD6 3BX, United Kingdom

For any information about this medicine, please contact the Marketing Authorisation Hol­der

This leaflet was last revised in December 2021 .

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Special precautions for handling and disposal

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should not be used.

Gammaplex 10% should be used immediately after opening. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Bio Products Laboratory

50007 Gammaplex 10% 50ml/100ml PIL UK GSUK5 1.indd 4

10/01/2022 15:37