Rhenium sulfide (186Re) colloid CIS Bio International 148-370 MBq/mL injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rhenium sulphide (186Re) colloidal CIS bio international 148-370 MBq/ml injectable suspension

Rhenium sulphide (186Re)

Read the entire leaflet carefully before you start using this medicine.

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

Leaflet contents:

1. What Rhenium sulphide (186Re) colloidal CIS bio international is and what it is used for
2. What you need to know before using Rhenium sulphide (186Re) colloidal CIS bio international
3. How to use Rhenium sulphide (186Re) colloidal CIS bio international
4. Possible side effects
5. How to store Rhenium sulphide (186Re) colloidal CIS bio international
6. Contents of the pack and other information

1. What Sulfuro de renio (186Re) coloidal CIS bio international is and what it is used for

This medicine is a radiopharmaceutical for therapeutic use only.

The active substance is rhenium sulfide (186Re).

Sulfuro de renio (186Re) coloidal CIS bio international is indicated for the treatment of rheumatoid disease affecting shoulder, elbow, wrist, ankle, and hip joints.

Administration of Sulfuro de renio (186Re) coloidal CIS bio international involves exposure to a small amount of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the radiation risk.

2. What you need to know before using Sulfuro de renio (186Re) CIS bio international

Do not use Sulfuro de renio (186Re) coloidal CIS bio international:

If you are allergic to rhenium sulfide (186Re) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with Sulfuro de renio (186Re) CIS bio international:

• If you are pregnant or think you may be pregnant
• If you are breastfeeding
• In children and young people during bone growth
• If you suffer from septic arthritis
• If you have a rupture of the synovial capsule
• If you are to be treated in the hip and have been administered a long-acting corticosteroid.

Before administration of Sulfuro de renio (186Re) CIS bio international,
you must avoid pregnancy by using an effective contraceptive method maintained for several months after treatment.

Children and adolescents

Consult your nuclear medicine physician if you are under 18 years of age.

Use of Sulfuro de renio (186Re) CIS bio international with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may 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 Sulfuro de renio (186Re) CIS bio international if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

If you are a woman of childbearing potential, you must use effective contraceptive measures before administration of this medicine and maintain them for several months after treatment.

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

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

If you are breastfeeding your child, consideration should be given to reasonably delaying the procedure with this medicine until you have stopped breastfeeding.

Driving and use of machines

No effects on the ability to drive or operate machinery have been observed.

Sulfuro de renio (186Re) CIS bio international contains sodium

This medicine contains 12.7 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.6% of the maximum daily sodium intake recommended for an adult. The amount of sodium administered could in some cases exceed 23 mg. Therefore, this should be taken into account if you are on a low-sodium diet.

3. How Sulfuro de renio (186Re) CIS bio international is used

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Sulfuro de renio (186Re) CIS bio international will be used only in specially controlled areas. This product will be handled and administered only by trained personnel qualified 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 physician supervising the procedure will determine the amount of Sulfuro de renio (186Re) coloidal CIS bio international to be used in your case, which will be the minimum quantity necessary to achieve the desired effect. The generally recommended administered amount for an adult is 70 to 110 MBq (Megabecquerel, the unit used to express radioactivity), depending on the joint being treated.

Administration of Sulfuro de renio (186Re) CIS bio international and performance of the procedure

Sulfuro de renio (186Re) CIS bio international is injected directly by your nuclear medicine physician into the shoulder, elbow, wrist, ankle, or hip joints.

Several joints may be treated simultaneously or sequentially.

In case of relapse, a new injection into the joint may be considered after a rest period of 6 months.

After administration of Sulfuro de renio (186Re) CIS bio international you should:

• Immobilize the joint for 3 days (using splints or bed rest)
• Use an effective contraceptive method for several months after treatment to prevent pregnancy.
• Avoid direct contact with young children and pregnant women.

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

If you have been administered more Sulfuro de renio (186Re) CIS bio international than you should have:

It is unlikely that an overdose will occur, as you will receive a single, precisely controlled dose of Sulfuro de renio (186Re) CIS bio international determined by the nuclear medicine physician supervising the procedure.

If you have any further questions about the use of Sulfuro de renio (186Re) CIS bio international, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

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

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 patients)

• Swelling due to fluid accumulation (edema)
• Pigmentation disorder

Uncommon (may affect up to 1 in 100 patients)

• Chromosomal abnormalities

Frequency not known (cannot be estimated from available data)

• Inflammation of the joints due to infection (infectious arthritis)
• Nausea
• Vomiting
• Loss of blood flow to the bones causing bone death (osteonecrosis)
• Loss of fluid in the joints (joint effusion)
• Inflammation of the joints
• Joint pain

The most frequently observed adverse reactions after radiosynoviorthesis with rhenium are:

• Brownish discoloration at the wrist injection site and sometimes infiltration and stiffness of the extensor muscles.
• Edema of the forearm following wrist radiosynoviorthesis.
• Transient local pain or inflammation of the joint (distension phenomenon) after joint puncture.
• Nausea and vomiting.
• Joint infection.
• Loss of blood flow to the bones causing bone death.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine specialist, even if it is an 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 Rhenium sulfide (186Re) colloid CIS bio International

You will not have to store this medicine. This medicine is stored under the responsibility of a specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations concerning radioactive materials.

6. Contents of the pack and other information

Composition of Rhenium Sulfide (186Re) CIS bio international

• The active substance is rhenium sulfide (186Re)
• The other components are: ascorbic acid, gelatin, sodium hydroxide, hydrochloric acid and water for injectable preparations.

Appearance of Rhenium Sulfide (186Re) CIS bio international and contents of the pack

This medicinal product is presented as an injectable suspension in multidose vials of 15 ml clear glass, closed with a rubber stopper and aluminum cap. The vial is supplied within a lead-shielded container.

Pack size: One vial contains 37 to 3700 MBq of rhenium (186Re) at a concentration of 148 to 370 MBq/mL 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
Tel.: 91 4841989

This leaflet was last reviewed in February 2020

Detailed and up-to-date 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/

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics (SmPC) for Rhenium Sulfide (186Re) CIS bio international is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.