Rhenium Sulfide (186Re) Colloidal CIS BIO INTERNATIONAL 148-370 MBq/mL Injectable Suspension

2. What you need to know before you start using Rhenium sulfide (186Re) CIS bio international

Do not use Rhenium sulfide (186Re) CIS bio international:

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

Warnings and precautions

Be careful with Rhenium sulfide (186Re) CIS bio international:

• If you are pregnant or think you may be pregnant
• If you are breast-feeding.
• In children and adolescents during bone growth
• If you have septic arthritis
• If you have a rupture of the synovial capsule.
• If you are going to be treated for the hip and have been given a long-acting corticosteroid.

Before administration of Rhenium sulfide (186Re) CIS bio international,

• you should avoid pregnancy by using an effective contraceptive method for several months after treatment.

Children and adolescents

Consult your nuclear medicine doctor if you are under 18 years old.

Using Rhenium sulfide (186Re) CIS bio international with other medicines

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before using this medicine.

You should tell your nuclear medicine doctor before administration of Rhenium sulfide (186Re) CIS bio international if there is any possibility that you are pregnant, if you have a delayed menstrual period, or if you are breast-feeding.

If you are a woman of childbearing age, you should use effective contraceptive measures before administration of this medicine and for several months after treatment.

In case of doubt, it is important that you consult your specialist nuclear medicine doctor who will supervise the procedure.

If you are pregnant or breast-feeding, you should not receive this medicine.

If you are breast-feeding, you should consider delaying the test with this medicine until you have stopped breast-feeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Rhenium sulfide (186Re) CIS bio international contains sodium

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

3. How to use Rhenium sulfide (186Re) CIS bio international

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Rhenium sulfide (186Re) CIS bio international will only be used in controlled areas. This product will only be handled and administered by trained and qualified personnel. These people 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 Rhenium sulfide (186Re) CIS bio international to be used in your case, which will be the minimum amount necessary to achieve the desired effect. The recommended amount for administration to an adult is 70 to 110 MBq (Megabecquerel, the unit used to express radioactivity) depending on the joint to be treated.

Administration of Rhenium sulfide (186Re) CIS bio international and performance of the procedure

Rhenium sulfide (186Re) CIS bio international is injected directly by your nuclear medicine doctor into the shoulder, elbow, wrist, ankle, or hip joints.

Several joints can be treated simultaneously or successively.

In case of relapse, a new injection into the joint may be considered after a 6-month break.

After administration of Rhenium sulfide (186Re) CIS bio international, you should:

• Keep the joint immobilized for 3 days (splints or bed rest)

• Use an effective contraceptive method for several months after treatment to avoid any pregnancy.
• Avoid direct contact with small children and pregnant women.

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

If you have been given more Rhenium sulfide (186Re) CIS bio international than you should:

It is unlikely that you will be given an overdose because you will receive a single, precisely controlled dose of Rhenium sulfide (186Re) CIS bio international by the nuclear medicine doctor who supervises the procedure.

If you have any further questions on the use of Rhenium sulfide (186Re) CIS bio international, ask your nuclear medicine doctor who supervises the procedure.

4. Possible side effects

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

The following side effects have been reported:

Common (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 the available data)

• Joint inflammation due to infection (septic arthritis)
• Nausea
• Vomiting
• Bone death due to loss of blood flow (osteonecrosis)
• Fluid loss in the joints (joint effusion)
• Joint inflammation
• Joint pain

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

• Brown discoloration of the wrist at the injection site and sometimes infiltration and stiffness of the extensor muscles.
• Swelling due to fluid accumulation (edema) of the forearm after wrist synovectomy.
• Transient local pain or joint inflammation (flare phenomenon) after joint puncture.
• Nausea and vomiting.
• Joint infection.
• Bone death due to loss of blood flow.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

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

5. Storage of Rhenium sulfide (186Re) CIS bio international

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

6. Contents of the pack and further 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 injections.

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

This medicine is presented as an injectable suspension in 15 ml glass vials closed with a rubber stopper and an aluminum cap. The vial is packaged with 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 on 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 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

This package leaflet was last revised in February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

The complete technical data sheet for Rhenium sulfide (186Re) 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.