ERBIUM CITRATE (169Er) colloidal CIS BIO INTERNACIONAL 111 MBq/ML INJECTABLE SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Erbium Citrate (169Er) Colloidal CIS bio international 111 MBq/ml Injectable Suspension

Erbium Citrate (169Er)

Read this entire leaflet carefully before starting to use this medication because 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 doctor who is supervising the procedure.
• If you experience side effects, consult the nuclear medicine doctor, even if they are side effects not listed in this leaflet. See section 4.

Contents of the Leaflet:

1. What is Erbium Citrate (169Er) Colloidal CIS bio international and what is it used for

2. Before using Erbium Citrate (169Er) Colloidal CIS bio international

3. How to use Erbium Citrate (169Er) Colloidal CIS bio international

4. Possible side effects

5. Storage of Erbium Citrate (169Er) Colloidal CIS bio international

6. Package Contents and Additional Information

1. What is Erbium Citrate (169Er) Colloidal CIS bio international and what is it used for

This medication is a radiopharmaceutical for therapeutic use only.

Erbium Citrate (169Er) Colloidal CIS bio international is indicated in adults for the treatment of arthritis during inflammatory flare-ups of small joints in the hands and feet, when intra-articular treatment with corticosteroids fails or is contraindicated.

Administration of Erbium Citrate (169Er) Colloidal CIS bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor consider that the clinical benefit you will obtain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before starting to use Erbium Citrate (169Er) Colloidal CIS bio international

Erbium Citrate (169Er) Colloidal 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 medication (listed in section 6).
• If you are pregnant or think you may 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 in the injection area.
• If you have recently had a synovial cyst rupture.

Warnings and Precautions

Be especially careful with Erbium Citrate (169Er) Colloidal CIS bio international and consult the nuclear medicine specialist:

• If you have undergone a procedure with X-ray contrast media in the last 3 days
• If you are a woman of childbearing age

Before administration ofErbium Citrate (169Er) Colloidal CIS bio internationalyou should avoid pregnancy by using an effective contraceptive method for several months after treatment.

Children and Adolescents

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

Use of Erbium Citrate (169Er) Colloidal CIS bio international with other medications:

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

Inform your nuclear medicine doctor if you have undergone a procedure with X-ray contrast media in the last 3 days, as it 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 medication.

You must inform your nuclear medicine doctor before administration of Erbium Citrate (169Er) Colloidal CIS bio international if there is any possibility that you are pregnant, if you have a delayed period, or if you are breastfeeding. In fact, Erbium Citrate (169Er) should not be administered to pregnant or breastfeeding women. If you are a woman of childbearing age, you should use effective contraceptive measures before receiving this medication and maintain them for several months after treatment.

In case of doubt, it is essential to consult the nuclear medicine specialist who will supervise the procedure.

Driving and Using Machines

Driving vehicles or using machines is not recommended due to joint immobilization after administration.

Erbium Citrate (169Er) Colloidal CIS bio international contains less than 23 mg of sodium (1mmol) per dose; this is essentially "sodium-free".

3. How to use Erbium Citrate (169Er) Colloidal CIS bio international

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Erbium Citrate (169Er) Colloidal CIS bio international will only be used in controlled facilities. This product will only be handled and administered by trained and qualified personnel to use it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor who supervises the procedure will decide the amount of Erbium Citrate (169Er) Colloidal CIS bio international to be used in your case. This will be the minimum amount necessary to achieve the desired effect. The generally recommended amount for administration to an adult is 10 to 80 MBq (Megabecquerel, the unit used to express radioactivity) depending on the joint to be treated.

Administration ofErbium Citrate (169Er) Colloidal CIS bio international and performance of the procedure

Erbium Citrate (169Er) Colloidal CIS bio international is injected directly into the small joints of the hands and feet by your nuclear medicine doctor.

Several joints can be treated simultaneously or successively.

A repeat injection of the radiopharmaceutical into a joint should not be done until at least six months have passed.

After administration of Erbium Citrate (169Er) Colloidal CIS bio international, you should:

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

Your nuclear medicine doctor will inform you if you need to take any precautions after receiving this medication. Consult your nuclear medicine doctor if you have any questions.

If you have received moreErbium Citrate (169Er) Colloidal CIS bio internationalthan you should have:

Overdose is unlikely because you will receive a single dose of Erbium Citrate (169Er) Colloidal CIS bio international per joint, controlled with precision by the nuclear medicine doctor who supervises the procedure. However, in case of overdose, you will receive appropriate treatment.

If you have any questions about the use of Erbium Citrate (169Er) Colloidal CIS bio international, ask the nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most frequently observed side effects after synoviorthesis with Erbium Citrate (169Er) Colloidal CIS bio international are:

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

This radiopharmaceutical will release small amounts of ionizing radiation, which is minimally associated with the risk of cancer or genetic defects.

Reporting side effects

If you experience any type of side effect, inform your nuclear medicine specialist, even if it is a side effect not included in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Erbium Citrate (169Er) Colloidal CIS bio international

You will not need to store this medication. This medication is stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

6. Package Contents and Additional Information

Composition ofErbium Citrate (169Er) Colloidal CIS bio international

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

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

Appearance of Erbium Citrate (169Er) Colloidal CIS bio international and package contents

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

Package size: 15 ml glass vials, sealed with a rubber stopper and aluminum cap. Contains between 0.1 and 10.0 ml, corresponding to an activity between 11 and 1110 MBq at the calibration date and time.

Marketing Authorization Holder and Manufacturer:

CIS bio international

RN 306 - Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

FRANCE

You can request more information about this medication by contacting 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 revised in June 2020

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

The following information is intended only for healthcare professionals:

The complete technical data sheet for Erbium Citrate (169Er) Colloidal CIS bio international is included as a separate document in the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Technical Data Sheet.