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

Package leaflet: Information for the user

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Igantibe is and what it is used for

Each Igantibe package contains:

• A pre-filled syringe with human hepatitis B immunoglobulin injectable solution containing antibodies against the hepatitis B virus.

This medicine belongs to the pharmacotherapeutic group known as immune sera and immunoglobulins.

The administration of Igantibe is indicated for:

?Hepatitis B immunoprophylaxis

• In case of accidental exposure in non-immunized individuals (including those with incomplete or unknown vaccination status).

• In patients undergoing hemodialysis, until vaccination becomes effective.

• In newborns of mothers who are carriers of the hepatitis B virus.

• In individuals who did not develop an immune response (undetectable anti-hepatitis B antibodies) after vaccination and who require ongoing prevention due to continued 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 by hepatitis B virus in HBV DNA-negative patients, in combination with nucleoside analogue therapy.

2. What you need to know before using 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

Talk to your doctor or pharmacist before starting to use Igantibe.

• Ensure that Igantibe is not administered into a blood vessel, due to the risk 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 will be obtained from administering this product.

• True hypersensitivity reactions are uncommon.

• Igantibe contains a small amount of IgA. If you have IgA deficiency, you may develop anti-IgA antibodies and experience allergic reactions after administration of blood-derived products containing IgA. Your doctor must weigh the benefits 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 rarely be at risk of experiencing an allergic reaction.

Special safety precautions

When medicines derived from human plasma or blood are administered, certain measures must be taken to prevent transmission of infections to patients. These measures include careful selection of donors to exclude those at risk of carrying infectious diseases, testing individual donations and plasma pools for specific markers of infection, and inclusion of steps in the manufacturing process to eliminate/inactivate viruses. Nevertheless, when medicines derived from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be completely ruled out. This also applies to emerging viruses or those of unknown nature, and other types of infections.

The measures taken are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as the non-enveloped hepatitis A virus. The measures may have limited effectiveness against 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 healthcare personnel administer a dose of Igantibe, they record the name of the medicine and the 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 currently using, or have recently used, any 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 vaccines. You may need to wait 3 months before receiving these vaccines.

Effects on blood tests

Inform the laboratory staff or your doctor that you have received this medicine if you undergo a blood test after receiving Igantibe. The levels of certain antibodies may be increased.

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 whether 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 negligible.

Important information about some of the components of Igantibe

This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore 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.

The appropriate dose will be determined by your doctor.

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

?Hepatitis B immunoprophylaxis:

• Prevention of hepatitis B following accidental exposure in non-immunized individuals:

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

• Hepatitis B immunoprophylaxis in patients undergoing hemodialysis:

8–12 IU/kg up to a maximum of 500 IU, every 2 months until seroconversion after vaccination.

• Prevention of hepatitis B in newborns of mothers who are carriers of 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 hepatitis B virus is highly recommended. The first vaccine dose may be administered on the same day as human hepatitis B immunoglobulin, but at different injection sites.

In individuals who did not mount an immune response (non-detectable anti-hepatitis B antibodies) after vaccination and who require ongoing prevention, administration of 500 IU in adults and 8 IU/kg in children every 2 months may be considered; the minimum protective antibody titer is considered to be 10 mIU/mL.

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

Dose required 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.

For this indication, there are no data on administration in children.

If a large volume is required (>2 mL in children or >5 mL in adults), administration in divided doses at different anatomical sites is recommended.

When simultaneous vaccination is necessary, immunoglobulin and vaccine should be administered at different anatomical sites.

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

Igantibe must not be mixed with other medicines.

Instructions for medicine administration

1. Open the plastic package containing the syringe, plunger, and needle.
2. Ensure the syringe is at room temperature (20–25 °C) before use.
3. Remove the syringe and plunger from the plastic holder.
4. Attach the plunger to the bottom of the syringe. Turn the plunger rod clockwise until the threads are securely 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 needle protective cap (do not remove the needle protector to prepare the product for administration until immediately before injection), expel air bubbles, and insert the needle into the tissue. Aspirate before injection to confirm 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 overdose are not known.

In case of overdose or accidental administration, contact 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Inform your doctor if you experience any of the following adverse reactions during or after the injection:

? Chills

? Fever

? Headache

? Nausea

? Vomiting

? Allergic reaction

? Joint pain

? Moderate back pain

Rare adverse effects:

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

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

Since the product was marketed, only one adverse reaction has been reported to the manufacturer, consisting of an episode of facial flushing, excessive eye irritation, and nausea.

Data from a clinical study indicate the following adverse event:

? Increase in the levels of a liver enzyme (alanine aminotransferase or ALT)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Igantibe

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

Must be brought to room temperature or body temperature before use.

The colour may vary from colourless to pale yellow or light brown. The solution should be clear or slightly opalescent, and a small amount of particles may appear during storage. Solutions should be inspected visually before administration. Do not use Igantibe if the solution appears cloudy or contains sediments.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. 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 an anti-hepatitis B antibody content of 200 IU/ml. The human protein content is 80 mg in 100 IU/0.5 ml pre-filled syringes, 480 mg in 600 IU/3 ml pre-filled syringes, and 800 mg in 1000 IU/5 ml pre-filled syringes, of which at least 95% is human immunoglobulin G.

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

See section 2, “What you need to know before using Igantibe”, for more information about the components.

Nature of the product and pack contents

Igantibe is an injectable solution in a pre-filled syringe. The solution is clear and ranges in color from pale yellow to light brown. Slight opalescence or a small amount of particles may appear during storage.

Presentations:

Igantibe 200 IU/ml

Pre-filled syringes containing 100 IU in 0.5 ml of solution

Pre-filled syringes containing 600 IU in 3 ml of solution

Pre-filled syringes containing 1000 IU in 5 ml of solution

Marketing Authorization Holder and Manufacturer

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

Date of the most recent review of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.es/)