QUADRAMET Injectable Solution

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 you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Quadramet and what is it used for

Quadramet is a medicinal product for therapeutic use only.

This radiopharmaceutical is used for the treatment of bone pain caused by your disease.

Quadramet has a high affinity for bone tissue. Once injected, it concentrates in bone lesions. As Quadramet contains small amounts of a radioactive element, samarium 153, it delivers local radiation to bone lesions, allowing for a palliative effect on bone pain.

2. What you need to know before you use Quadramet

Do not use Quadramet:

• If you are allergic to ethylenediaminetetramethylene phosphonic acid (EDTMP), to similar compounds with phosphonates or to any of the other components of this medicinal product (listed in section 6).
• If you are pregnant,
• If you have received chemotherapy or external hemibody radiotherapy in the 6 weeks prior to administration of the medicinal product.

Warnings and precautions

Consult your doctor before starting to take Quadramet.

Your doctor will take blood samples from you every week for at least 8 weeks to measure your platelet count, red and white blood cell count, which may decrease slightly due to treatment.

In the 6 hours following administration of Quadramet, your doctor will instruct you to drink and urinate as frequently as possible. He will decide when you can leave the nuclear medicine department.

In case of urinary incontinence or urinary obstruction, a urinary catheter will be inserted for approximately 6 hours. In other patients, urine will be collected for at least 6 hours.

If you have reduced renal function, the amount of medicinal product to be administered will be adjusted.

Children and adolescents

QUADRAMET is not recommended for use in children under 18 years of age.

Use of Quadramet with other medicinal products

Tell your doctor if you are using, have recently used or might use any other medicinal products.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you might be pregnant or plan to become pregnant, consult your doctor before using this medicinal product.

Quadramet must not be administered to pregnant women.

If administration of Quadramet to a breastfeeding woman is considered necessary, breastfeeding should be interrupted.

3. How to use Quadramet

Before administering Quadramet to you, your doctor will want to perform a special diagnostic examination (scintigraphy) to determine if you can benefit from Quadramet.

Posology

A single dose of 37 megabecquerels (the becquerel is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight should be injected.

If you feel that the effect of Quadramet is too strong or too weak, consult your doctor or pharmacist.

Method and route of administration

Quadramet should be administered by slow injection into a vein.

Frequency of administration

The injection of this medicinal product is not performed on a regular or continuous basis. However, administration may be repeated after 8 weeks of the last injection, depending on the evolution of your disease.

Duration of treatment

You may leave the nuclear medicine department after undergoing dosimetric follow-up (usually within 6 hours after injection of Quadramet).

If you use more Quadramet than you should

As Quadramet is supplied in a single-dose vial, accidental overdose is unlikely.

The radiation dose received by the body can be limited by increasing fluid intake and urinating frequently.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicinal products, Quadramet can cause side effects, although not everybody gets them.

The side effects caused by the administration of Quadramet are related to a decrease in red and white blood cells and platelets. Cases of bleeding, some of them severe, have been reported.

For this reason, your blood counts will be strictly monitored during several weeks after the injection of Quadramet.

Exceptionally, you may notice a slight increase in bone pain a few days after the injection of Quadramet. Do not be alarmed; in this case, your pain medication will be slightly increased. It is a brief and moderate effect that will disappear within a few hours.

Adverse drug reactions such as nausea, vomiting, diarrhea, and sweating have been reported.

Hypersensitivity reactions, including rare cases of anaphylactic reaction after administration of Quadramet, have been reported.

In rare cases, the following adverse reactions have been observed: neuralgia, coagulation disorders, and cerebrovascular accidents. These effects were considered to be related to the progression of the disease.

If you experience back pain or sensitivity disorders, inform your doctor as soon as possible.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Annex V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Quadramet

Keep this medicinal product out of the sight and reach of children.

Do not use Quadramet after the expiry date stated on the pack.

Quadramet expires the day after the reference time of activity stated on the label.

Store in a freezer at -10°C to -20°C in the original package.

Quadramet should be used within 6 hours after thawing. Do not refreeze after thawing.

The label on the medicinal product states the appropriate storage conditions and the expiry date for the batch of the medicinal product. Hospital staff will ensure that the product is stored correctly and not administered after the expiry date stated.

Storage procedures must comply with national regulations on radioactive materials.

6. Contents of the pack 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 on the reference date (corresponding to 20 - 80 µg/ml of samarium per vial).

The other components are total EDTMP (as EDTMP.H2O), sodium calcium EDTMP salt (as Ca), total sodium (as Na), water for injections.

Appearance of Quadramet and contents of the pack

Quadramet is a solution for injection.

This medicinal product is a clear, colorless to pale amber solution filled in a 15 ml type I glass vial, closed with a natural rubber/butyl rubber stopper coated with teflon and an aluminum cap.

Each vial contains 1.5 ml (2 GBq on the reference date) to 3.1 ml (4 GBq on the reference date) of solution for injection.

Marketing authorization holder and manufacturer

CIS bio international

Boîte Postale 32

F-91192 Gif-sur-Yvette cedex

France

Date of last revision of this leaflet: {MM/AAAA}

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

This information is intended only for healthcare professionals: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 in the product packaging.

Consult the Summary of Product Characteristics (which must be included in the packaging)