Quadramet - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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 taking 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 your pharmacist.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Quadramet is and what it is used for

• 2. What you need to know before you take Quadramet

• 3. How to take Quadramet

• 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 is a medicinal product for therapeutic use only.

This radiopharmaceutical is used for the treatment of bone pain due to your disease.

Quadramet has a high affinity for skeletal tissue. Once injected it concentrates in bone lesions.

Because Quadramet contains small amounts of a radioactive element, samarium-153, radiations are delivered locally to the bone lesions, allowing to develop the palliative action on bone pain.

2. What you need to know before you take Quadramet

Do not take Quadramet:

• If you are allergic to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds or any of the other ingredients of this medicine (listed in section 6), If you are pregnant,
• If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.

3. How to take Quadramet

Your doctor will want to carry out a special scan before administering Quadramet to ascertain whether you are likely to benefit from Quadramet.

Dosage

One single dose of 37 megabecquerel (Becquerel is the unit in which radioactivity is measured) of Quadramet per kilogram of body weight is to be injected.

If you have the impression that the effect of Quadramet is too strong or too weak, talk to your doctor or pharmacist.

Method and route of administration

Quadramet is to be administered by slow injection into a vein.

Frequency of administration

This medicinal product is not intended to be injected on a regular or continuous basis. The administration can however be repeated after 8 weeks following injection, subject to the evolution of your disease.

Duration of treatment

You will be authorised to leave the nuclear medicine department after a dosimetric follow-up (generally within 6 hours following Quadramet injection).

If you take more Quadramet than you should

Quadramet being supplied as a single-dose vial, an accidental overdose is unlikely to occur.

Radiation dose to the body can be limited by increasing fluid intake and frequent voiding of urine.

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

4. Possible side effects

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

The undesirable effects due to Quadramet administration are linked with a decrease of red and white blood cells, and platelets. Cases of bleeding have been reported, some of which have been serious.

This is the reason why your blood counts will be monitored strictly for a few weeks following Quadramet injection.

You may exceptionally feel a slight increase in bone pain a few days after Quadramet injection. You should not be alarmed at this; in such case, your pain medicine will be slightly increased. This effect is moderate and brief and will disappear after some hours.

Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating were reported.

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

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

If you experience back pain or sensory abnormalities, please inform your physician as soon as possible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Quadramet

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

Do not use Quadramet after the expiry date which is stated on the label.

Quadramet expires 1 day from the activity reference time stated on the label.

Store at –10°C to –20°C in a freezer in its original packaging.

Quadramet should be used within 6 hours of thawing. After thawing, do not freeze again.

The product label includes the appropriate storage conditions and the expiry date for the batch of product. Hospital personnel will ensure that the product is stored correctly and not administered to you after the stated expiry date.

Storage procedures should be in accordance with national regulations for radioactive materials.

6. Contents of the pack and other information

What Quadramet contains

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

Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date (corresponding to 20–80 ^g/ml of samarium per vial).

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

What Quadramet looks like and contents of the pack

Quadramet is a solution for injection.

This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.

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

Marketing authorisation holder and manufacturer

CIS bio international

Boîte Postale 32

F-91192 Gif-sur-Yvette cedex

France

The leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site: .

The following information is intended for medical or healthcare professionals only:

The complete SmPC of Quadramet is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmace­utical.

Please refer to the SmPC (SmPC should be included in the box)

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