Erbium citrate (169Er) colloidal CIS Bio Internacional 111 MBq/mL injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citrato de erbio (169Er) coloidal CIS bio international 111 MBq/ml injectable suspension

erbium citrate (169Er)

Read this 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 the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, consult the nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Citrato de erbio (169Er) coloidal CIS bio international is and what it is used for

2. Before using Citrato de erbio (169Er) coloidal CIS bio international

3. How to use Citrato de erbio (169Er) coloidal CIS bio international

4. Possible adverse effects

5. How to store Citrato de erbio (169Er) coloidal CIS bio international

6. Contents of the pack and other information

1. What Citrato de erbio (169Er) coloidal CIS bio international is and what it is used for

This medicine is a radiopharmaceutical intended solely for therapeutic use.

Citrato de erbio (169Er) coloidal CIS bio international is indicated in adults for the treatment of arthritis during inflammatory flare-ups of the small joints of the hands and feet, when intra-articular corticosteroid treatment has failed or is contraindicated.

Administration of Citrato de erbio (169Er) coloidal CIS bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician consider that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Citrato de erbio (169Er) coloidal CIS bio international

Citrato de erbio (169Er) coloidal CIS bio international must not be used:

• If you are allergic (hypersensitive) to erbium citrate (169Er) or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding your child.
• In children and young patients under 20 years of age.
• If you have an infection in the joint to be treated.
• If you have local infections or skin disorders at the injection site.
• If you have recently ruptured a synovial cyst.

Warnings and precautions

Take special care with Citrato de erbio (169Er) coloidal CIS bio international and consult a nuclear medicine specialist:

• If you have undergone any X-ray contrast procedures within the last 3 days.
• If you are a woman of childbearing potential.

Before administration of Citrato de erbio (169Er) coloidal CIS bio international, you must avoid pregnancy using an effective contraceptive method, which should be maintained for several months after treatment.

Children and adolescents

Inform your nuclear medicine specialist if you are under 20 years of age.

Use of Citrato de erbio (169Er) coloidal CIS bio international with other medicines:

Inform the nuclear medicine specialist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Inform your nuclear medicine physician if you have undergone any procedures involving X-ray contrast agents within the last 3 days, as this may interfere with the treatment outcome.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine specialist before receiving this medicine.

You must inform the nuclear medicine physician before administration of Citrato de erbio (169Er) coloidal CIS bio international if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding. Indeed, erbium citrate (169Er) must not be administered to pregnant or breastfeeding women. If you are a woman of childbearing potential, you must use effective contraception before administration of this medicine and continue it for several months after treatment.

If in doubt, it is important to consult the nuclear medicine specialist who will supervise the procedure.

Driving and use of machines

Driving vehicles or operating machinery is not recommended due to joint immobilization following administration.

Citrato de erbio (169Er) coloidal CIS bio international contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.

3. How Citrato de erbio (169Er) coloidal CIS bio international is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Citrato de erbio (169Er) coloidal CIS bio international will only be used in specially controlled facilities. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in ensuring the safe use of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Citrato de erbio (169Er) coloidal CIS bio international to be used in your case. This will be the minimum quantity necessary to achieve the desired effect. The generally recommended dose for administration in adults ranges from 10 to 80 MBq (Megabecquerel, the unit used to express radioactivity), depending on the joint being treated.

Administration of Citrato de erbio (169Er) coloidal CIS bio international and performance of the procedure

Citrato de erbio (169Er) coloidal CIS bio international is injected by your nuclear medicine physician directly into the small joints of the hands and feet.

Several joints may be treated simultaneously or successively.

A repeat injection of the radioactive product into a joint will not be given until at least six months have passed.

After receiving Citrato de erbio (169Er) coloidal CIS bio international, you should:

• Keep the joint immobilized for 2 days (using splints or bed rest).
• Use an effective contraceptive method for several months after treatment to avoid pregnancy.

The nuclear medicine physician will inform you if any precautions are necessary after receiving this medication. Consult your nuclear medicine physician if you have any doubts.

If you have received more Citrato de erbio (169Er) coloidal CIS bio international than you should have:

An overdose is unlikely, as you will receive a precisely controlled single dose of Citrato de erbio (169Er) coloidal CIS bio international per joint, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be given.

If you have any questions about the use of Citrato de erbio (169Er) coloidal CIS bio international, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

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

The most frequently observed adverse effects after radiosynoviorthesis with colloidal Erbium-169 (169Er) citrate CIS bio international are:

• Very common (may affect more than 1 in 10 people): pain, swelling at the injection site, acute arthritis (recurrence of inflammation during the first week after administration).
• Common (may affect up to 1 in 10 people): fever, joint mobility dysfunction, skin pigmentation.
• Very rare (may affect up to 1 in 10,000 people): redness, severe skin reactions with blistering.
• Frequency not known (cannot be estimated from available data): secondary joint infection, joint inflammation, skin necrosis, rash and itching.

This radiopharmaceutical will emit small amounts of ionizing radiation, which is minimally associated with a risk of cancer or hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, inform your specialist in nuclear medicine, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Colloidal erbium citrate (169Er) CIS bio international

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Radioactive pharmaceuticals will be stored in accordance with national regulations concerning radioactive materials.

6. Contents of the pack and other information

Composition of Erbium (169Er) Citrate Colloid CIS bio international

• The active substance is Erbium (169Er) Citrate.

• The other components are: nitric acid, sodium hydroxide, sodium chloride, and water for injections.

Appearance of Erbium (169Er) Citrate Colloid CIS bio international and contents of the pack

Erbium (169Er) Citrate Colloid CIS bio international is presented as an injectable suspension in a multidose vial.

Pack size: 15 ml glass vials, sealed with a rubber stopper and aluminium cap. Each vial contains between 0.1 and 10.0 ml, corresponding to an activity between 11 and 1110 MBq at the date and time of calibration.

Marketing Authorization Holder and Manufacturer:

CIS bio international
RN 306 - Saclay
B.P. 32
F-91192 Gif-sur-Yvette Cedex
FRANCE

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Curium Pharma Spain, S.A.
Avda. Dr. Severo Ochoa, 29
28100 Alcobendas
Phone: 91 4841989

This leaflet was last reviewed in June 2020

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS): http://www.aemps.gob.es/

The following information is intended for medical or healthcare professionals only:

The full Summary of Product Characteristics (SmPC) for Erbium (169Er) Citrate Colloid CIS bio international is included as a separate document within the product packaging, intended for healthcare professionals, providing additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.