QUADRAMET, SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quadramet 1.3 GBq/ml solution for injection

samarium (153Sm) lexidronam pentasodium

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

• 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 adverse effects, consult your nuclear medicine physician, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Quadramet is and what it is used for
2. What you need to know before receiving Quadramet
3. How Quadramet is administered
4. Possible side effects
5. How to store Quadramet
6. Contents of the pack and other information

1. What Quadramet is and what it is used for

Quadramet contains the active substance samarium (153Sm) lexidronam pentasodium.

This medicine is a radiopharmaceutical for therapeutic use only.

Quadramet is used to treat bone pain caused by your disease.

Quadramet has a high affinity for bone tissue. Once injected, it concentrates in bone lesions. Since Quadramet contains small amounts of a radioactive element, samarium (153Sm), it delivers localized radiation to the bone lesions, providing palliative relief from bone pain.

Administration of Quadramet involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the risk associated with radiation exposure.

2. What you need to know before using Quadramet

Do not use Quadramet:

• If you are allergic to samarium (153Sm) lexidronam pentasodium or to similar phosphate compounds or to any of the other components of this medicine (listed in section 6),
• If you are pregnant or think you might be pregnant,
• If you have received chemotherapy or hemibody radiotherapy within the previous 6 weeks.

Warnings and precautions

Consult your nuclear medicine physician before receiving Quadramet.

• If you have reduced kidney function, the dose of the medicine will be adjusted accordingly.
• If you have urinary problems (obstruction or incontinence), special care will be taken to collect urine.
• If you have received treatment with other bisphosphonates.
• If your blood cell counts are severely affected.

Before administration of Quadramet you must:

• Undergo a bone scan to determine whether you are likely to benefit from Quadramet.
• Drink plenty of water before the procedure begins, to urinate as frequently as possible during the first few hours after completion.

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years of age, as this product may not be suitable for you.

Use of Quadramet with other medicines

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine. You must inform the nuclear medicine physician before administration of Quadramet if there is any possibility you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

If in doubt, it is important to consult your nuclear medicine physician, who will supervise the procedure.

If you are pregnant

Quadramet must not be administered to pregnant women.

If you are breastfeeding

If Quadramet administration is necessary, breastfeeding must be discontinued.

Driving and using machines

Quadramet is considered unlikely to affect your ability to drive or operate machinery.

Quadramet contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., essentially "sodium-free".

3. How to use Quadramet

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Quadramet will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel competent 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 decide the amount of Quadramet to be used in your case. This will be the smallest quantity necessary to achieve the desired effect.

The generally recommended dose for administration in an adult is 37 MBq per kg of body weight (MBq: megabecquerel, the unit used to express radioactivity).

Administration of Quadramet and performance of the procedure

Quadramet must be administered by slow intravenous injection.

This medication is not administered on a regular or continuous basis. However, administration may be repeated after 8 weeks from the last injection, depending on the progression of your disease and whether your blood counts have recovered after the previous treatment.

Duration of treatment

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

After administration of Quadramet, you should:

• avoid close contact with young children and pregnant women during the 48 hours following the injection
• urinate frequently to eliminate the product from your body. The nuclear medicine physician will inform you when you will be discharged from the hospital. In case of urinary incontinence or urinary obstruction, a urinary catheter will be placed for approximately 6 hours.

Your physician will take weekly blood samples for at least 8 weeks to monitor your platelet and red and white blood cell counts, which may decrease slightly due to the treatment.

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 given more Quadramet than you should have

An overdose is unlikely, as you will receive a single dose of Quadramet precisely controlled by the physician supervising the procedure.

However, in the event of an overdose, appropriate treatment will be administered.

If you have any further questions about the use of Quadramet, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

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

The frequency of adverse effects is:

Very common: may affect more than 1 in 10 people

• Decrease in red and white blood cells and platelets

Common: may affect up to 1 in 10 people

• Bone pain
• Nausea
• Dizziness
• Excessive fatigue

Uncommon: may affect up to 1 in 100 people

• Bleeding disorders
• Failure of the bone marrow to produce blood and immune cells
• Intracranial hemorrhage
• Stroke
• Spinal cord compression
• Vomiting
• Excessive sweating
• Loss of appetite

Frequency not known: cannot be estimated from the available data

• Hypersensitivity

• Severe allergic reaction

• Diarrhea

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Quadramet

This medicine does not need to be stored by the patient.

This medicine is stored under the responsibility of the specialist in suitable facilities.

Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

6. Package contents and other information

Composition of Quadramet

• The active substance is samarium (153Sm) lexidronam pentasodium.

Each ml of solution contains 1.3 GBq/ml of samarium (153Sm) lexidronam pentasodium at the time of calibration (equivalent to 20 - 80 µg/ml of samarium per vial).

• The other components are EDTMP, calcium-EDTMP sodium salt, sodium, water for injections.

Appearance of Quadramet and package contents

Quadramet is an injectable solution.

Each vial contains 1.5 ml (2 GBq at time of calibration) to 3.1 ml (4 GBq at time of calibration) of injectable solution.

Marketing Authorization Holder and Manufacturer

CIS bio international

Boîte Postale 32

F-91192 Gif-sur-Yvette cedex

France

Date of the most recent revision of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.ema.europa.eu/

This information is intended for healthcare professionals only:

For detailed information, refer to the Summary of Product Characteristics of QUADRAMET. In order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical, the Summary of Product Characteristics of Quadramet is included as a separate document within the product packaging.

Please consult the Summary of Product Characteristics.