Yttrium (90Y) citrate Curium Italy

Package leaflet: Information for the patient

Yttrium ( Y) citrate Curium Italy 167, 200, 235, 280 or 336 MBq/mL

injectable suspension
yttrium ( Y) citrate
Please read 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 the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet

1. What Ittrio ( Y) citrate Curium Italy is and what it is used for
2. What you need to know before you are given Ittrio ( Y) citrate Curium Italy
3. How Ittrio ( Y) citrate Curium Italy is administered
4. Possible side effects
5. How Ittrio ( Y) citrate Curium Italy is stored
6. Contents of the pack and other information

1. What Ittrio (Y) citrato Curium Italy is and what it is used for

This medicinal product is a radiopharmaceutical for therapeutic use only.
The active substance is ittrio (Y) citrato.
Ittrio (Y) citrato Curium Italy is used in adults for the treatment of the knee (radiosynovectomy) in the presence of conditions such as arthritis due to chronic inflammatory rheumatism, particularly rheumatoid arthritis.
The use of Ittrio (Y) citrato Curium Italy involves exposure to a certain amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you should know before being administered Yttrium (Y)

citrate Curium Italy
Yttrium ( Y) citrate IBA must not be administered

• if you are allergic to Yttrium (Y) citrate Curium Italy or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or suspect you may be pregnant
• if you are breastfeeding
• if you have localized infections or skin diseases at the injection site
• if you suffer from septic arthritis of the knee
• if you have ruptured popliteal cysts
• if you are under 18 years of age.

Warnings and precautions
Exercise particular caution with Yttrium ( Y) citrate Curium Italy
Contact your nuclear medicine physician in the following cases:

• if you are a woman of childbearing potential (see section Pregnancy and breastfeeding),
• if you have a popliteal cyst that might rupture,
• if you have a severely damaged knee joint with bone tissue destruction or cartilage loss.

Your physician will inform you about any special precautions to be taken after using this product.
Children and adolescents
Yttrium (Y) citrate IBA must not be administered to children and adolescents.
Inform your nuclear medicine physician if you are under 18 years of age.
Other medicines and Yttrium ( Y) citrate Curium Italy
Inform your nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, including those without a prescription, as they may affect the quality of results obtained with Yttrium (Y) citrate Curium Italy treatment.
Inform your nuclear medicine specialist if you have recently been administered a radiographic contrast agent, since it is recommended to wait at least 8 days before treatment.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your nuclear medicine physician before receiving this medicine.
Inform your nuclear medicine physician before administration of Yttrium (Y) citrate Curium Italy if there is any possibility that you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If you have any doubts, it is important to consult the nuclear medicine physician supervising the procedure.
If you are a woman of childbearing potential, you must use an effective contraceptive method before treatment and continue using it for at least 4 months after treatment.
This medicine must not be administered if you are pregnant or breastfeeding.
If you are breastfeeding, you should consider reasonably delaying treatment until you have finished breastfeeding.
Driving and using machines
Intra-articular injection of this medicine precludes driving vehicles and operating machinery, as it must be followed by immobilization of the knee and bed rest for 2–3 days to prevent extra-articular spread of the radiopharmaceutical.
Yttrium ( Y) citrate Curium Italy contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose and is therefore essentially "sodium-free".

3. How Ittrio (Y) citrato Curium Italy is administered

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Ittrio (Y) citrato Curium Italy must be used only in designated controlled areas. This product must be handled and administered only by healthcare personnel trained and qualified to use it in accordance with safety standards. These individuals will pay particular attention to the safe use of this product and will keep you informed about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Ittrio (Y) citrato Curium Italy to be used in your case. This will be the smallest amount necessary to achieve the desired effect. The normally recommended administered activity for an adult ranges from 185 to 220 MBq per knee (MBq: the megabecquerel is the unit used to express radioactivity).

If symptoms recur, administration of the product may be repeated after 6 months in the same previously treated knee.

Administration of Ittrio (Y) citrato Curium Italy and performance of the procedure

The product is administered by injection into the knee joint, after removal of any excess joint fluid.

Duration of the procedure

The nuclear medicine physician will inform you about the usual duration of the procedure.

After administration of Ittrio (Y) citrato Curium Italy, you must remain in bed for 2 or 3 days with absolute immobilization of the knee to minimize the amount of product that could migrate outside the joint.

The nuclear medicine physician will inform you about any special precautions you need to take after receiving this medicinal product. If you have any doubts about the use of this medicine, consult your nuclear medicine physician.

If you have been given more Ittrio (Y) citrato Curium Italy than you should have received

Overdose is unlikely, as you will receive only a single, carefully controlled dose of Ittrio (Y) citrato Curium Italy, administered under the supervision of the nuclear medicine physician. However, in the event of overdose, you will receive appropriate treatment, which may include immobilization and cooling of the joint, removal of any joint effusion, and intrarticular injection of a corticosteroid medication.

If you have any further questions about the use of Ittrio (Y) citrato Curium Italy, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Common (may affect up to 1 in 10 people)

• transient fever reaction (pyrexia), occurring in approximately 2% of treated cases within 24 hours after injection.

Uncommon (may affect up to 1 in 100 people)

• inflammation of the knee joint into which the product was administered, which may appear after several hours or days. This inflammation can be treated with an analgesic or a non-steroidal anti-inflammatory drug.

Not known (frequency cannot be estimated from the available data)

• pain at the injection site
• secondary joint infection (infectious arthritis)
• blood tumor (myeloid leukemia)
• tumor of the lymph nodes or tissues (lymphoma)
• allergic reactions (hypersensitivity)
• skin death (skin necrosis)
• black discoloration of the skin (pigmentation disorders)
• destruction of knee bone tissue (osteonecrosis)
• hereditary defects (cytogenetic abnormalities)

Carcinogenic (tumor) and leukemogenic risk (leukemia, blood tumor
affecting white blood cells)
Exposure to ionizing radiation is associated with tumor induction and a potential risk of hereditary defects.
A single case of chronic myeloid leukemia (myeloid leukemia) and one case of malignant inguinal lymphoma (lymphoma) have been reported after treatment of over 20,000 joints over a 20-year observation period.
However, a causal relationship between these diseases and radiosynoviectomy has not been established.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your Nuclear Medicine physician. You may also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Ittrio (Y) citrate Curium Italy is stored

Do not store this medicinal product. This medicinal product is stored under the responsibility of a specialist in appropriate facilities. Radiopharmaceuticals must be stored in accordance with current national regulations concerning radioactive materials.
The following information is intended for specialists only.
The medicinal product must be kept in its original packaging at a temperature not exceeding 25°C.
After the first withdrawal from the vial, the medicinal product must be stored in a refrigerator (2°–8°C) and used within 8 hours.
Ittrio (Y) citrate Curium Italy must not be used after the expiry date stated on the secondary packaging and on the vial.

6. Package contents and other information

What Ittrio (⁹⁰Y) citrate Curium Italy contains

• The active substance is yttrium (⁹⁰Y) citrate. One mL of suspension contains 167, 200, 235, 280 or 336 MBq of yttrium (⁹⁰Y) citrate at the date and time of calibration.
• The other components are: sodium chloride, water for injections, sodium hydroxide, nitric acid and sodium citrate.

Description of the appearance of Ittrio (⁹⁰Y) citrate Curium Italy and
contents of the pack
This medicinal product is supplied in a glass vial containing a sterile, milky white colloidal suspension. A vial contains between 0.3 and 10 mL of suspension.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Curium Italy S.r.l.
Via Nicola Piccinni 2,
I-20131 Milano
Manufacturer
Cis bio international
R.N. 306 – Saclay
B.P. 32
F-91192 GIF-SUR-YVETTE CEDEX
More detailed information on this medicinal product is available on the website

The following information is intended exclusively for healthcare professionals:

The full product characteristics summary of Yttrium (Y) citrate Curium Italy is provided as a separate document, aimed at providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.