Imukin 100 micrograms solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

IMUKIN 100 micrograms injection solution

Recombinant human interferon gamma-1b

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What IMUKIN is and what it is used for

IMUKIN contains an active substance called recombinant human interferon gamma-1b. Interferons are also known as immunomodulators. These are small proteins capable of stimulating the body's immune system defense mechanisms. They provide protection against microorganisms (for example, bacteria, viruses, and fungi) that can cause disease.

IMUKIN is used in patients with chronic granulomatous disease (CGD). CGD is a metabolic deficiency in neutrophils, a type of white blood cell that normally eliminates bacteria or fungi invading the body. The deficiency in CGD impairs the ability of neutrophils to prevent infections.

IMUKIN is used to reduce the frequency of serious infections that may occur with this disease.

IMUKIN is also used in patients with severe malignant infantile osteopetrosis. This is a hereditary defect in bone cells that causes excessive and abnormal bone growth. It also affects the bone marrow and the blood cells normally produced within it. As a result, patients with osteopetrosis are also at risk of serious infections.

2. What you need to know before using IMUKIN

Do not use IMUKIN

• if you are allergic to gamma interferon or to other related interferons, or to any of the other ingredients of this medicine (listed in section 6).

Ask your doctor or pharmacist if you are unsure whether you are allergic to interferons.

Warnings and precautions

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

Take special care with IMUKIN

• if you have heart disease, as doses higher than the usual doses may worsen your heart condition (see section 3 for dosage information)
• if you have seizure disorders and/or disturbances in central nervous system function
• if your liver does not function properly (hepatic insufficiency)
• if your kidneys do not function properly (renal insufficiency)
• if your bone marrow does not produce blood cells in normal quantities (myelosuppression)
• if you are allergic to latex, as the rubber stopper of the glass vial contains natural rubber (a latex derivative) which may cause allergic reactions.

Consult your doctor if any of the above conditions currently apply to you or have occurred in the past.

You should avoid using IMUKIN together with other medicines containing proteins. You should also avoid using IMUKIN at the same time as receiving a vaccine. Consult your doctor if you have any doubts about this.

You must continue to undergo the tests used in the treatment of CGD and malignant infantile osteopetrosis. Your blood cell counts, urine, and liver and kidney function should be carefully monitored both before and during treatment.

High levels of interferon gamma-1b in the body may impair fertility in both men and women.

Other medicines and IMUKIN

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You may need antibiotics to treat infections that still occur while you are using IMUKIN for the treatment of CGD. IMUKIN has not been shown to affect the efficacy of antibiotics or corticosteroids, medicines commonly used in patients with CGD and malignant infantile osteopetrosis.

Medicines that affect the liver or kidneys may influence the elimination of IMUKIN from the body. IMUKIN may prolong the activity of other medicines that are broken down and eliminated from the body by the liver.

If you use IMUKIN together with medicines or vaccines that have effects on the heart, blood, bone marrow, nervous system, or immune system, the risk of adverse effects may increase.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Based on available information, effects on fertility are not known, but cannot be ruled out. IMUKIN should not be used during pregnancy unless your doctor considers it essential. Breastfeeding is not recommended during treatment with IMUKIN. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

IMUKIN may cause fatigue, seizures, confusion, disorientation, or distorted or imaginary sensations (hallucinations). These adverse effects may reduce reaction ability and therefore may negatively affect your capacity to drive or operate machinery. Do not drive or operate machinery if you notice that your reaction ability is impaired.

IMUKIN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.5 ml vial, and is therefore considered essentially “sodium-free”.

This may be important for people with high blood pressure and for others who wish to maintain a low-sodium diet.

3. How to use IMUKIN

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

IMUKIN must be administered by a subcutaneous injection (under the skin). IMUKIN may be administered by a doctor or nurse, or also by yourself or a family member, provided that you have been properly trained by a doctor or nurse.

The recommended dose of IMUKIN for the treatment of patients with CGD or severe malignant osteopetrosis is 50 micrograms/m² in patients whose body surface area is greater than 0.5 m² and 1.5 micrograms/kg for patients whose body surface area is equal to or less than 0.5 m².

Your doctor will decide how much IMUKIN you need to use for the treatment of CGD or severe malignant osteopetrosis.

You must inject (or should be injected) the exact amount of IMUKIN your doctor has indicated. Administer the injections 3 times per week (for example, Monday, Wednesday, and Friday), preferably in the evening. Recommended injection sites are the upper arm or the upper thigh.

• Before administering the injection, always check the amount of IMUKIN solution.

• Do not use IMUKIN if you can see small particles or discoloration in the solution.

• Do not mix IMUKIN with other medicines.

• Do not shake IMUKIN vials vigorously.

If you use more IMUKIN than you should

Contact your doctor immediately if you have administered more IMUKIN than your doctor prescribed, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet to the healthcare professional.

Symptoms following an overdose of IMUKIN may include:

• central nervous system adverse effects such as difficulty thinking, difficulty walking, and dizziness
• if you have a heart condition, it may worsen temporarily
• blood disorders may occur during treatment with IMUKIN, including:
• temporary changes in the number of certain blood cells
• increased levels of certain substances (liver enzymes and triglycerides) in the blood.

Your doctor can detect these abnormalities through a blood test.

These symptoms resolve with dose reduction or discontinuation of IMUKIN treatment.

If you forget to use IMUKIN

Do not take a double dose to make up for missed doses.

Administer your injections according to the schedule recommended by your doctor. You may still administer the missed dose on the same day or the following day. Consult your doctor if you think you have gone too long without administering a dose.

If you stop using IMUKIN

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Inform your doctor if you stop using IMUKIN.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The risk of developing adverse effects depends on the dose and treatment schedule prescribed to you.

The most common adverse effects are flu-like symptoms such as fever, headache, chills, and fatigue.

These may decrease in severity over time as treatment continues. Some of these symptoms may be minimized by administering IMUKIN just before going to bed. A medicine such as paracetamol may be used to reduce some of these effects.

Some patients using IMUKIN may experience short-term skin problems, such as temporary skin rash, maculopapular rash, sudden appearance of blisters on the skin, and redness at the injection site.

However, these reactions have rarely been severe enough to require discontinuation of IMUKIN treatment.

The adverse effects listed below are grouped according to the likelihood of their occurrence.

Very common adverse effects (may affect more than 1 in 10 people):

• fever
• headache
• chills
• injection site pain
• vomiting
• nausea (feeling unwell)
• diarrhoea
• fatigue
• elevated liver enzyme levels
• skin rash

Common adverse effects (may affect up to 1 in 10 people):

• muscle pain
• joint pain
• back pain
• stomach pain
• depression

Frequency not known (cannot be estimated from available data):

• decrease in white blood cells (neutropenia)
• decrease in blood platelets (thrombocytopenia), which may be associated with bruising and a tendency to bleed
• protein in the urine

Adverse effects have also been observed in patients with diseases other than EGC and malignant osteopetrosis. These adverse effects have not been observed in clinical trials related to EGC or malignant osteopetrosis.

The following adverse effects have been reported in clinical trials involving patients with disorders/diseases different from EGC or malignant osteopetrosis. The usual doses used in these studies were higher than those recommended for the treatment of EGC and malignant osteopetrosis. For this reason, their exact frequency cannot be determined.

Frequency not known (cannot be estimated from available data):

• low levels of sodium in the blood, which may cause tiredness and confusion, muscle cramps, seizures, or coma (hyponatremia)
• high levels of a sugar called glucose (hyperglycemia)
• fatty acids called triglycerides (hypertriglyceridemia) in the blood

The following nervous system disorders have been observed:

• confusion
• disorientation
• effects on walking ability, such as parkinsonian gait
• tremors
• seizures
• distorted or imaginary sensations (hallucinations)

The following heart disorders have also been observed:

• additional and irregular heartbeats
• changes in heart rhythm, such as increased or decreased rate
• heart problems that may cause difficulty breathing or ankle swelling (heart failure)
• heart attack

The following blood system disorders have also been reported:

• low blood pressure
• fainting
• transient mild stroke (transient ischaemic attack)
• blood clots or blockage of a lung artery (deep vein thrombosis and pulmonary embolism); symptoms may include difficulty breathing

The following respiratory disorders have occurred:

• rapid breathing

• chest tightness (bronchospasm or interstitial lung disease)

• gastrointestinal bleeding

• inflammation of the pancreas, which may be fatal

• liver damage affecting liver function (liver failure)

• kidney damage affecting kidney function, but which may be effectively treated (reversible renal failure)

• chest pain

• worsening of a skin disease called dermatomyositis (presents as a skin rash accompanied by muscle weakness)

• development of a long-term disease called systemic lupus erythematosus (the patient's own immune system attacks various parts of the body)

• autoimmune reaction (autoantibody response)

Reporting of adverse effects

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

5. Storage of IMUKIN

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

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

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

IMUKIN injection solution vials are for single use only. IMUKIN does not contain preservatives.

After opening, the contents of a vial should be used immediately. Discard any remaining solution.

Do not use this medicine if, before administration, you notice the presence of particles or discoloration.

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

6. Contents of the pack and other information

Composition of IMUKIN

• The active substance is recombinant human gamma interferon-1b. Each vial (0.5 ml) contains 100 micrograms (2 x 106 IU) of recombinant human interferon gamma-1b. It is produced by the genetically modified bacterium E. coli.
• The other components are D-mannitol, disodium succinate hexahydrate, polysorbate 20, succinic acid, and water for injections.

The vial stopper contains natural rubber (a derivative of latex).

Appearance of the product and contents of the pack

IMUKIN is a clear, colourless injectable solution. It is available in 4 ml vials containing 0.5 ml of solution.

Pack sizes: 1, 3, 5, 6 and 12 vials in a cardboard box. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Clinigen Healthcare B.V.

Schiphol Boulevard 359

WTC Schiphol Airport, D Tower 11th floor

1118BJ Schiphol

The Netherlands

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate

Dundalk,

Co. Louth

A91 P9KD

Ireland

or

Almac Pharma Services Limited

Seagoe Industrial Estate

BT63 5UA Craigavon

Northern Ireland, United Kingdom

This medicinal product is authorised in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: November 2022

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.gob.es/