Yttrium (90Y) citrate colloid CIS bio international 37–370 MBq/ml injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citrato de ytrio (90Y) coloidal CIS bio international 37-370 MBq/ml injectable suspension

Yttrium (90Y) citrate

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your nuclear medicine physician who supervises the procedure.
• If you get any side effects, talk to your nuclear medicine physician, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Citrato de ytrio (90Y) coloidal CIS bio international is and what it is used for
2. What you need to know before using Citrato de ytrio (90Y) coloidal CIS bio international
3. How to use Citrato de ytrio (90Y) coloidal CIS bio international
4. Possible side effects
5. How to store Citrato de ytrio (90Y) coloidal CIS bio international
6. Contents of the pack and other information

1. What Citrato de ytrio (90Y) coloidal CIS bio international is and what it is used for

This medicine is a radiopharmaceutical intended solely for therapeutic use.

Citrato de ytrio (90Y) coloidal CIS bio international is indicated for the treatment of the knee in cases of synovial hypertrophy (radiosynovectomy), primarily for monoarthritis or oligoarthritis in chronic inflammatory rheumatic diseases, especially rheumatoid polyarthritis.

Administration of Citrato de ytrio (90Y) coloidal CIS bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will derive from the radiopharmaceutical procedure outweighs the risk from radiation exposure.

2. What you need to know before Citrato de ytrio (90Y) coloidal CIS bio international is used

Citrato de ytrio (90Y) coloidal CIS bio international must not be used:

• If you are allergic to Yttrium (90Y) citrate or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
• If you suffer from septic arthritis of the knee.
• If you have a ruptured synovial cyst.
• If you have localized infections or skin conditions at the injection site.

Warnings and precautions

Take special care with Citrato de ytrio (90Y) coloidal CIS bio international:

Inform the nuclear medicine physician in the following cases:

• If you have an unstable knee joint.
• If you have undergone a knee X-ray within the last 8 days.
• If you have severe bone tissue destruction.
• If you have ankylosed joints.
• If you have significant loss of articular cartilage sequestration.

Whenever possible, your doctor should avoid administering Citrato de ytrio (90Y) coloidal CIS bio international to individuals of reproductive age with reproductive potential.

• If you are a woman of childbearing age, you must use effective contraception before starting treatment and continue it for several months afterwards.

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years of age, as administration should be avoided in children during bone growth whenever possible.

Use of Citrato de ytrio (90Y) coloidal CIS bio international with other medicines:

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

Inform your nuclear medicine physician if you have recently received an X-ray contrast agent. An interval of at least 8 days is recommended after local use of an EDTA-containing contrast agent or other chelating agents.

Pregnancy, breastfeeding and fertility

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

You must inform your nuclear medicine physician before administration of Citrato de ytrio (90Y) coloidal CIS bio international if there is any possibility you are pregnant, if you have missed a period, or if you are breastfeeding.

If in doubt, it is important to consult the doctor or nuclear medicine physician supervising the procedure.

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

If you are breastfeeding, it should be considered whether it is reasonable to delay the procedure with this medicine until you have stopped breastfeeding.

Whenever possible, administration of this medicine should be avoided in individuals of reproductive age.

Driving and use of machines

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

Citrato de ytrio (90Y) coloidal CIS bio international contains 7.4 mg/mL of sodium.

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

3. How Citrato de ytrio (90Y) coloidal CIS bio international is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Citrato de ytrio (90Y) coloidal CIS bio international will only be used in specially controlled areas. This medicine 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 medicine and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Citrato de ytrio (90Y) coloidal CIS bio international to be used in your case. This will be the minimum quantity necessary to achieve the desired effect.

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

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

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

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

The annual activity should not exceed 444 MBq per knee.

Administration of Citrato de ytrio (90Y) coloidal CIS bio international and performance of the procedure

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

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

Duration of the procedure

Your nuclear medicine physician will inform you of the expected duration of the procedure.

After administration of Citrato de ytrio (90Y) coloidal CIS bio international you should:

• observe strict 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 for several months after treatment.

The nuclear medicine physician will inform you if you need to take special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more Citrato de ytrio (90Y) coloidal CIS bio international than you should have received

An overdose is unlikely, as you will receive a single dose of Citrato de ytrio (90Y) coloidal CIS bio international precisely controlled by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered.

If you have any further questions about the use of Citrato de ytrio (90Y) coloidal CIS bio international, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

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

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

Allergic reactions have rarely been observed.

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

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

There are infrequent cases in which skin necrosis and blackish skin discoloration occur as a consequence of the administration method.

In rare instances, secondary joint infection may occur after radiation synovectomy.

Cases of destruction of knee bone tissue have been reported.

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

Exposure to ionizing radiation is associated with cancer induction and potential development of hereditary defects.

Very rarely, chronic myeloid leukaemia (one case) and malignant inguinal lymphoma (one case) have occurred. However, a definite relationship between these conditions and radiation synovectomy has not been established.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or your nuclear medicine physician, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via 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. Storage of Yttrium (90Y) Citrate Colloid CIS bio international

You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

6. Contents of the container and other information

Composition ofCitrato de ytrio (90Y) coloidal CIS bio international

• The active substance is Yttrium citrate (90Y). Each ml of injectable suspension contains between 37–370 MBq/ml of Yttrium citrate (90Y) at the date and time of calibration.

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

Presentation of the medicinal product and contents of the container

This medicine is presented in a glass vial as a milky white injectable suspension. A 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

Further information about this medicinal product may be requested from the local representative of the Marketing Authorization Holder.

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

AEMPS Registration Number: 75966

This medicinal product is authorized in the following countries:

Date of the most recent review of this leaflet: 06/2018

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

This information is intended exclusively for healthcare professionals:

The Summary of Product Characteristics for Citrato de ytrio (90Y) coloidal CIS bio international is included as a separate document within the product packaging, to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.