QUADRAMET, solution for injection

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.

Do not take QUADRAMET:

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

Take special care with QUADRAMET:

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

Your doctor will take blood samples weekly for at least 8 weeks to check your platelets, white and red blood cell counts which may slightly decrease due to the therapy.

During 6 hours following the injection of QUADRAMET, your physician will encourage you to drink and void as often as possible. He will decide at which time you will be authorised to leave the nuclear medicine department.

In the case of urine incontinence or urinary obstruction you will get a urine catheter for about 6 hours. For the other patients the urine should be collected for at least 6 hours.

If your renal function is decreased, the amount of product will be adapted.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

Pregnancy and breast-feeding:

QUADRAMET must not be administered to pregnant women.
If QUADRAMET administration to a breastfeeding woman is deemed necessary, breastfeeding should be stopped.

Ask your doctor or pharmacist for advice before taking any medicine.

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.

Like all medicines, QUADRAMET can have 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight 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.

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 20-46 gml 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 approved on ().

The following information is intended for medical or healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of QUADRAMET.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

Read directions for use thoroughly before starting the preparation procedure.

All procedures should be conducted using aseptic techniques and standard precautions for handling radionuclides.

Use of radiopharmaceutical agents

Radiopharmaceuticals should only be used by qualified personnel with the appropriate government authorisation for the use and handling of radionuclides. This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the local competent official organisations.

Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical requirements. Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practice for pharmaceuticals.

Method of preparation

Allow the product to thaw at room temperature before administration.

The solution for injection should be visually inspected before use. It should be clear without particles. The operator should be careful to protect the eyes while inspecting the solution for clarity.

The activity should be measured by a dose calibrator immediately before administration. Verification of the dose to be administered and patient identification are necessary prior to administration of QUADRAMET.

Usual precautions regarding sterility and radioprotection should be respected.

The administration of radiopharmaceuticals creates risks to other persons from external radiation or contamination from spills of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

For radiation safety reasons, the patient should be treated in a facility with the appropriate agreement for the therapeutic use of radioactive non-sealed sources. He will be released when exposure rates comply with the limits prescribed by the regulations in force.

Radioactive waste must be disposed of in conformity with the relevant national and international regulations.