Yttrium Citrate (90 Y) Colloidal CIS BIO INTERNATIONAL 37-370 MBq/ml Injectable Suspension

Introduction

Package Leaflet: Information for the Patient

Yttrium Citrate (90Y) Colloidal CIS bio international 37-370 MBq/ml Injectable Suspension

Yttrium Citrate (90Y)

Read all of this leaflet carefully before this medicine is administered to you, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who is supervising the procedure.
• If you experience side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What Yttrium Citrate (90Y) Colloidal CIS bio international is and what it is used for
2. What you need to know before using Yttrium Citrate (90Y) Colloidal CIS bio international
3. How to use Yttrium Citrate (90Y) Colloidal CIS bio international
4. Possible side effects
5. Storage of Yttrium Citrate (90Y) Colloidal CIS bio international
6. Package Contents and Additional Information

1. What Yttrium Citrate (90Y) Colloidal CIS bio international is and what it is used for

This medicine is a radiopharmaceutical for therapeutic use only.

Yttrium Citrate (90Y) Colloidal CIS bio international is indicated for the treatment of the knee in cases of synovial hypertrophy (radioisotopic synovectomy) mainly for monoarthritis or oligoarthritis in chronic inflammatory rheumatic diseases, especially rheumatoid polyarthritis.

Administration of Yttrium Citrate (90Y) Colloidal CIS bio international involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before using Yttrium Citrate (90Y) Colloidal CIS bio international

Yttrium Citrate (90Y) Colloidal CIS bio international must not be used:

• If you are allergic to Yttrium Citrate (90Y) or any of the other components of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• If you have septic arthritis of the knee.
• If you have a ruptured synovial cyst.
• If you have localized infections or skin conditions present in the injection area.

Warnings and Precautions

Be particularly careful with Yttrium Citrate (90Y) Colloidal CIS bio international:

Inform your nuclear medicine doctor in the following cases:

• If you have an unstable knee joint.
• If you have had a knee X-ray in the last 8 days.
• If you have severe bone tissue destruction or
• Ankylosed joints.
• If you have significant loss of articular cartilage. Whenever possible, your doctor should avoid administering Yttrium Citrate (90Y) Colloidal CIS bio international to individuals of childbearing potential with reproductive potential.
• If you are a woman of childbearing potential, before starting treatment, you should begin effective contraception and continue it for several months after treatment.

Children and Adolescents

Tell your nuclear medicine doctor if you are under 18 years old, as administration should be avoided in children during bone growth whenever possible.

Using Yttrium Citrate (90Y) Colloidal CIS bio international with other medicines:

Tell your doctor or nuclear medicine doctor supervising the procedure if you are taking, have recently taken, or may need to take any other medicine, including those obtained without a prescription, as they may affect the quality of the results obtained with Yttrium-90 treatment.

Inform your nuclear medicine doctor if you have recently been administered an X-ray contrast agent. It is recommended to have an interval of at least 8 days after local use of a contrast agent containing EDTA or other chelating agents.

Pregnancy, Breastfeeding, and Fertility

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

You must inform your nuclear medicine doctor before administration of Yttrium Citrate (90Y) Colloidal CIS bio international if there is any possibility that you are pregnant, if you have missed your period, or if you are breastfeeding.

In case of doubt, it is essential to consult your doctor or nuclear medicine doctor supervising the procedure.

If you are pregnant or breastfeeding, you should not receive this medicine.

If you are breastfeeding your child, you should consider delaying the test with this medicine until you have stopped breastfeeding.

Whenever possible, administration of this medicine should be avoided during childbearing age.

Driving and Using Machines

Intra-articular injection of Yttrium (90Y) should be followed by immobilization of the knee, with bed rest for 2 or 3 days to reduce extra-articular migration of the radiopharmaceutical.

Yttrium Citrate (90Y) Colloidal CIS bio international contains 7.4 mg/mL of sodium.

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

3. How to use Yttrium Citrate (90Y) Colloidal CIS bio international

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Yttrium Citrate (90Y) Colloidal CIS bio international will only be used in special controlled areas. This medicine will only be handled and administered by qualified personnel trained to use it safely. These individuals will take special care in the safe use of this medicine and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Yttrium Citrate (90Y) Colloidal CIS bio international to be used in your case. This will be the minimum amount necessary to achieve the desired effect.

The recommended amount to be administered is normally between 185 and 222 MBq per joint. (Megabecquerel, the unit of measurement used to express radioactivity).

Several joints can be treated simultaneously. In the case of a relapse, re-injection of radioactive colloid into a joint can be performed after a period of 6 months.

The recommended activity range for re-treatment is 111-222 MBq.

After two unsuccessful radiosynovectomies in the same joint, this treatment should not be repeated.

The annual activity should not exceed 444 MBq per knee.

Administration of Yttrium Citrate (90Y) Colloidal CIS bio international and performance of the procedure

The dose is administered by injection directly into the joint to be treated.

Before injection, most of the fluid present in the cavity to be treated should be removed by aspiration.

Duration of the procedure

Your nuclear medicine doctor will inform you of the normal duration of the procedure.

After administration of Yttrium Citrate (90Y) Colloidal CIS bio international, you should:

• be recommended to have absolute immobilization of the knee, with bed rest for 2 or 3 days. This is to reduce extra-articular migration of the radiopharmaceutical.
• use effective contraception during several months after treatment.

Your nuclear medicine doctor will inform you if you need to take special precautions after being administered this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been administered more Yttrium Citrate (90Y) Colloidal CIS bio international than you should:

Overdose is unlikely because you will receive a single, precisely controlled dose of Yttrium Citrate (90Y) Colloidal CIS bio international by the supervising nuclear medicine doctor. Nevertheless, in the event of an overdose, you will receive appropriate treatment.

If you have any further questions about the use of Yttrium Citrate (90Y) Colloidal CIS bio international, ask your nuclear medicine doctor supervising the procedure.

4. Possible side effects

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

In approximately 2% of cases, a transient fever reaction may occur within 24 hours of injection.

Allergic reactions have been rarely observed.

In some cases, the injection of radioactive colloid can be painful.

Inflammation may appear in the joint several hours or days after synovectomy. Your doctor may treat this inflammation with analgesic and non-steroidal anti-inflammatory drugs.

There are rare cases where skin necrosis and dark discoloration of the skin occur due to the method of administration.

In rare cases, a secondary joint infection occurs after radiosynovectomy.

Cases of destruction of knee bone tissue have been reported.

Carcinogenic risk (cancer) and leukaemogenic risk (leukaemia; blood cancer affecting white blood cells)

Exposure to ionizing radiation is linked to the induction of cancer and potential development of hereditary defects.

In very rare cases, chronic myeloid leukaemia (one case) and malignant inguinal lymphoma (one case) have occurred. However, the relationship between these pathologies and radiosynovectomy has not been determined with certainty.

Reporting of side effects

If you experience any side effects, consult your doctor or nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaRAM.es.

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

5. Storage of Yttrium Citrate (90Y) Colloidal CIS bio international

You will not need to store this medicine. This medicine is stored under the responsibility of a 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 of Yttrium Citrate (90Y) Colloidal CIS bio international

• The active ingredient is Yttrium Citrate (90Y). Each mL of injectable suspension contains between 37-370 MBq/mL Yttrium Citrate (90Y) on the calibration date and time.

• The other ingredients are: sodium chloride solution and sodium hydroxide (to adjust the pH).

Appearance of the product and package contents

This medicine is presented in a glass vial as a white, milky injectable suspension. One vial contains between 1 mL and 10 mL of injectable suspension.

Marketing Authorization Holder and Manufacturer:

CIS bio international

BP 32 - 91192 Gif sur Yvette Cedex

FRANCE

You can request more information about this medicine from the local representative of the Marketing Authorization Holder.

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

AEMPS Registration Number: 75966

This medicine is authorized in the following countries:

Date of last revision of this leaflet: 06/2018

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

This information is intended only for healthcare professionals:

The complete technical data sheet for Yttrium Citrate (90Y) Colloidal CIS bio international is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical data sheet.