IGANTIBE 200 IU/mL Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Igantibe 200 IU/ml solution for injection in pre-filled syringe

Human hepatitis B immunoglobulin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• 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 you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Igantibe and what is it used for
2. What you need to know before you use Igantibe
3. How to use Igantibe
4. Possible side effects
5. Storage of Igantibe
6. Contents of the pack and other information

1. What is Igantibe and what is it used for

Each pack of Igantibe contains:

• A pre-filled syringe with a solution for injection of human hepatitis B immunoglobulin containing antibodies against the hepatitis B virus.

This medicine belongs to a group of medicines called immune sera and immunoglobulins.

Administration of Igantibe is indicated in:

?Hepatitis B immunoprophylaxis

• In case of accidental exposure in non-immunized subjects (including individuals whose vaccination is incomplete or unknown).

• In patients undergoing hemodialysis, until vaccination becomes effective.

• In newborns of mothers carrying the hepatitis B virus.

• In subjects who did not develop an immune response (unmeasurable anti-hepatitis B antibodies) after vaccination and who require continuous prevention due to ongoing risk of hepatitis B infection.

?Prevention, during the maintenance phase after one year of liver transplantation due to liver failure caused by hepatitis B, of reinfection with hepatitis B virus in HBV-DNA negative patients together with nucleoside analog treatment.

2. What you need to know before you use Igantibe

Do not use Igantibe

• if you are allergic (hypersensitive) to human immunoglobulins or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Igantibe.

• Make sure Igantibe is not administered into a blood vessel, due to the possibility of shock.

• Intramuscular administration of this medicine may cause pain and other discomfort at the injection site.

• If you are a carrier of HBsAg, no benefit is obtained by administering this product.

• True hypersensitivity reactions are rare.

• Igantibe contains a small amount of IgA. If you have IgA deficiency, you may develop anti-IgA antibodies and suffer allergic reactions after administration of blood-derived products (hemoderivatives) that contain IgA. Your doctor should weigh the benefit of treatment with Igantibe against the potential risks of hypersensitivity reactions.

• Rarely, human hepatitis B immunoglobulin may cause a drop in blood pressure with an allergic reaction, even if you have previously tolerated treatment with human immunoglobulin.

• If you have a reaction to other antibodies, you may be at risk of an allergic reaction in rare cases.

Special safety precautions

When administering medicines derived from human plasma or blood, certain measures must be taken to prevent infections from being transmitted to patients. These measures include careful selection of donors to exclude those at risk of carrying infectious diseases, analysis of specific infection markers in individual donations and plasma pools, as well as inclusion of stages in the manufacturing process to eliminate/inactivate viruses. Despite this, when administering medicines derived from human blood or plasma, the possibility of transmitting infectious agents cannot be entirely excluded. This also applies to emerging or unknown viruses or other types of infections.

The measures taken 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. The measures taken may have limited value for non-enveloped viruses such as parvovirus B19.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections, possibly because the antibodies against these infections contained in the product are protective.

It is highly recommended that each time a healthcare professional administers a dose of Igantibe, they record the name of the medicine and batch number administered in order to maintain a record of the batches used.

Other medicines and Igantibe

?Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

?Effects on vaccines: Igantibe may reduce the effectiveness of certain types of vaccines such as measles, rubella, mumps, and varicella. You may need to wait 3 months before receiving these vaccines.

Effects on blood tests

Inform the analyst or your doctor that you have received this medicine if a blood test is performed after receiving Igantibe. The level of some antibodies may increase.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are pregnant or breastfeeding. Your doctor will decide if Igantibe can be used during pregnancy and breastfeeding.

Driving and using machines

The influence of Igantibe on the ability to drive and use machines is nil.

Important information about some of the ingredients of Igantibe

This medicine contains less than 23 mg (1 mmol) of sodium per dose, so it is considered essentially "sodium-free".

3. How to use Igantibe

This medicine is intended for intramuscular administration and will be administered by a doctor or nursing staff.

Your doctor will determine the appropriate amount to be administered.

Follow these instructions unless your doctor has given you different instructions.

?Hepatitis B immunoprophylaxis:

• Prevention of hepatitis B in case of accidental exposure in non-immunized subjects:

At least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably between 24 and 72 hours.

• Hepatitis B immunoprophylaxis in patients undergoing hemodialysis:

8-12 IU/kg with a maximum of 500 IU, every 2 months until seroconversion after vaccination.

• Prevention of hepatitis B in newborns of mothers carrying the hepatitis B virus, at birth or as soon as possible after birth:

30-100 IU/kg. Administration of hepatitis B immunoglobulin should be repeated until seroconversion after vaccination.

In all these situations, vaccination against the hepatitis B virus is highly recommended. The first dose of the vaccine can be administered on the same day as the human hepatitis B immunoglobulin, but in different sites.

In subjects who did not develop an immune response (unmeasurable anti-hepatitis B antibodies) after vaccination and who require continuous prevention, administration of 500 IU in adults and 8 IU/kg in children every 2 months may be considered; the minimum protective antibody titre is considered to be 10 mIU/ml.

?Prevention, during the maintenance phase after one year of liver transplantation due to liver failure caused by hepatitis B, of reinfection with hepatitis B virus in HBV-DNA negative patients together with nucleoside analog treatment:

What is necessary to maintain antibody levels above 100-150 IU/l in HBV-DNA negative patients. Administration of 2000 IU of Igantibe every 2 weeks has been shown to achieve these levels in adult patients.

There are no data on administration in children for this indication.

If a large volume is required (>2 ml in children or >5 ml in adults), it is recommended to administer it in fractionated doses and in different anatomical regions.

When simultaneous vaccination is necessary, the immunoglobulin and vaccine should be administered in two different anatomical regions.

If intramuscular administration is contraindicated (coagulation disorders), patients should be treated with other medicines.

Igantibe should not be mixed with other medicines.

Instructions for administration of the medicine

1. Open the plastic container that contains the syringe, plunger, and needle.
2. Make sure the syringe is at room temperature (20-25°C) before use.
3. Separate the syringe and plunger from the plastic support.
4. Attach the plunger to the lower part of the syringe. Turn the plunger rod clockwise until the threads are engaged.
5. Remove the cap from the top of the syringe and then attach the needle to the syringe.
6. Prepare the patient's injection site.
7. Remove the protective cap from the needle (do not remove the needle protector to prepare the product for administration until just before injection), expel air bubbles, and insert the needle into the tissue. Aspirate before injection to confirm that the needle is not in a vein or artery. Inject the product intramuscularly.

If you use more Igantibe than you should

If you have been administered more Igantibe than you should, consult your doctor or pharmacist immediately.

The consequences of an overdose are not known.

In case of overdose or accidental administration, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to use Igantibe

Consult your doctor or pharmacist immediately and follow their instructions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor if you suffer from any of the following adverse reactions during or after injection:

? Chills

? Fever

? Headache

? Nausea

? Vomiting

? Allergic reaction

? Joint pain

? Moderate back pain

Rare side effects:

? Sudden drop in blood pressure and, in isolated cases, anaphylactic shock, even if you have not suffered allergic reactions (hypersensitivity) in previous administrations.

Local reactions at the injection site: swelling, pain, redness, induration, local heat, itching, hematoma, and rash.

Since the marketing of the product, only one adverse reaction has been reported to the manufacturer, which was an episode of flushing of the face, excessive irrigation of the eyes, and nausea.

Data from a clinical study indicate the following adverse event:

? Increase in liver enzyme values (alanine aminotransferase or ALT)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Igantibe

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

It should be brought to room temperature or body temperature before use.

The color may vary from colorless to pale yellow to light brown. The solution should be clear or slightly opalescent, and during storage, a small amount of particles may appear. Products in solution should be visually inspected before administration. Do not use Igantibe if you notice that the solution is turbid or contains sediment.

Medicines should not be disposed of via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Igantibe

• The active substance is human hepatitis B immunoglobulin.

Igantibe has a content of anti-hepatitis B antibodies of 200 IU/ml. The content of human proteins is 80 mg in pre-filled syringes of 100 IU/0.5 ml, 480 mg in pre-filled syringes of 600 IU/3 ml, and 800 mg in pre-filled syringes of 1000 IU/5 ml, of which at least 95% is human immunoglobulin G.

• The other ingredients are glycine, sodium chloride, and water for injections.

See section 2, "What you need to know before you use Igantibe", for more information on the ingredients.

Appearance of the product and contents of the pack

Igantibe is a solution for injection in a pre-filled syringe. The solution is clear and pale yellow to light brown in color. During storage, a slight opalescence or a small amount of particles may appear.

Presentation:

Igantibe 200 IU/ml

Syringes of 100 IU in 0.5 ml solution

Syringes of 600 IU in 3 ml solution

Syringes of 1000 IU in 5 ml solution

Marketing authorization holder and manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

Date of last revision of this leaflet: March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.es/)