Patient Information Leaflet

Quadramet 1,3 GBq/ml injectable solution

Samarium (153Sm) lexidronam pentasodium

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

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

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

Quadramet is a medication for exclusive therapeutic use.

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

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

Do not use Quadramet:

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

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, red blood cell, and white blood cell counts, which may decrease slightly due to treatment.

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

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

If you experience a reduction in renal function, the amount of medication to be administered will be adjusted.

Children and adolescents

Quadramet is not recommended for use in children under 18 years old.

Use of Quadramet with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Quadramet should not be administered to pregnant women.

If Quadramet administration is considered necessary for a breastfeeding woman, the breastfeeding period should be interrupted.

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

Dosage

It must be injected with a single dose of 37 megabequerelios (the bequerelio is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight.

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

Method and Route of Administration

Quadramet must be administered by slow injection into a vein.

Administration Frequency

The injection of this medication is not performed regularly or continuously. However, administration may be repeated after 8 weeks of the last injection, depending on the evolution of your disease.

Treatment Duration

You will be able to leave the nuclear medicine department after undergoing a dosimetric follow-up (usually within 6 hours after the injection of Quadramet).

If You Use More Quadramet Than You Should

Since Quadramet is supplied in a single-dose vial, it is unlikely that an accidental overdose will occur.

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

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

Like all medications, Quadramet may produce adverse effects, although not everyone will experience them.

The adverse effects associated with the administration of Quadramet are related to a decrease in red and white blood cells and platelets. Cases of bleeding, some of which are severe, have been reported.

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

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

Adverse reactions to the medication such as nausea, vomiting, diarrhea, and sweating have been reported.

Adverse reactions to hypersensitivity, 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 sensory abnormalities, inform your doctor as soon as possible.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAnnex V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the reach and sight of children.

Do not use Quadramet after the expiration date that appears on the packaging.

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

Store between -10°C and -20°C in a freezer in the original packaging.

Quadramet must be used within 6 hours after thawing. Do not re-freeze after thawing.

The label of the medication indicates the appropriate storage conditions and expiration date for the batch of the medication. Hospital staff will ensure that the product is stored correctly and not administered after the indicated expiration date.

Storage procedures must comply with national regulations on radioactive materials.

Composition of Quadramet

The active principle is samarium (153Sm) lexidronam pentasodium.

Each milliliter 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), calcium EDTMP sodium salt (as Ca), total sodium (as Na), and water for injection.

Appearance of Quadramet and contents of the packaging

Quadramet is an injectable solution.

This medication is a transparent, colorless to light amber-colored solution packaged in a colorless type I glass vial from the European Pharmacopeia, 15 ml, closed with a natural rubber/ chlorobutyl 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 injectable solution.

Holder of the marketing authorization and responsible manufacturer

CIS bio international

Boîte Postale 32

F-91192 Gif-sur-Yvette cedex

France

Date of the last review of this leaflet: {MM/AAAA}

The detailed information on this medication is available on the European Medicines Agency (EMEA) websitehttp://www.ema.europa.eu/

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

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