Quadramet
Italy
Table of Contents
Package leaflet: Information for the patient
Quadramet 1.3 GBq/ml injection solution
Samarium (Sm) lexidronam pentasodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Quadramet is and what it is used for
- What you need to know before receiving Quadramet
- How to receive Quadramet
- Possible side effects
- How to store Quadramet
- Contents of the pack and other information
1. What Quadramet is and what it is used for
Quadramet is a medicinal product intended for therapeutic use only.
This radiopharmaceutical is used to treat bone pain caused by your disease.
Quadramet has a high affinity for skeletal tissue. After injection, it concentrates in bone lesions.
Since Quadramet contains small amounts of a radioactive element, samarium-153,
the radiation is localized primarily to the bone lesions, providing relief from bone pain.
2. What you need to know before taking Quadramet
Do not take Quadramet:
- if you are allergic to ethylenediaminetetramethylenephosphonic acid (EDTMP) or to similar phosphonate compounds, or to any of the other ingredients of this medicine (listed in section 6),
- during pregnancy,
- if you have undergone chemotherapy or external radiotherapy of one half of the body within the previous 6 weeks.
Warnings and precautions
Talk to your doctor before taking Quadramet.
Your doctor will carry out weekly blood tests for a period of at least 8 weeks to monitor the number of platelets, white blood cells, and red blood cells, which may slightly decrease due to the treatment.
During the 6 hours following the injection of Quadramet, your doctor will encourage you to drink fluids and to urinate as frequently as possible. Your doctor will also determine the time at which you are allowed to leave the nuclear medicine department.
If you have urinary incontinence or urinary obstruction, a catheter will need to be inserted for approximately 6 hours. For other patients, urine must be collected for at least 6 hours.
If you have reduced kidney function, the administered amount of the product will be adjusted accordingly.
Children and adolescents
The use of Quadramet is not recommended in children and adolescents under 18 years of age.
Other medicines and Quadramet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Quadramet must not be given to women during pregnancy.
If administration of Quadramet is considered necessary in women who are breastfeeding, breastfeeding must be discontinued.
3. How to take Quadramet
Your doctor will perform a bone scintigraphy before administering Quadramet to confirm
that you may benefit from the treatment.
Dosage:
A single dose of 37 megabecquerels (the becquerel is the unit of measurement for
radiation) of Quadramet per kg of body weight must be injected.
If you feel that the effect of Quadramet is too strong or too weak, discuss this with your doctor or
pharmacist.
Method and route of administration:
Quadramet must be administered by slow intravenous injection.
Frequency of administration:
This medicine is not intended for continuous or regular use. However, administration may be
repeated 8 weeks after the first injection, depending on the progression of the disease.
Duration of treatment:
You will be allowed to leave the nuclear medicine department after a dosimetric check
(generally within 6 hours after administration of the Quadramet injection).
If you take more Quadramet than you should
Quadramet is supplied in single-dose vials, making accidental overdose unlikely.
Radiation exposure to the body can be reduced by increasing fluid intake and frequent
emptying of the bladder.
If you have any doubts about the use of this product, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects due to the use of Quadramet are related to a decrease in the number of white and red blood cells and platelets. Cases of bleeding, some of which were serious, have been reported.
This is why regular blood checks are performed for several weeks after injection of Quadramet.
You may exceptionally experience a slight increase in bone pain a few days after the injection of Quadramet. You should not be concerned about this: in such cases, the dose of pain medication you are taking will be slightly increased. This effect is mild and short-lived, and disappears after a few hours.
Adverse drug reactions such as nausea, vomiting, diarrhoea and sweating have been reported.
Hypersensitivity reactions, including rare cases of anaphylactic reactions, have been reported following administration of Quadramet.
In rare cases, the following adverse effects have been observed: neuralgia, coagulation disorders, cerebrovascular events. These effects have been attributed to disease progression.
If you experience back pain or sensory abnormalities, inform your doctor as quickly as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex 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 stated on the label.
Quadramet expires 1 day after the reference activity date indicated on the label.
Store in a freezer (from -10°C to -20°C) in the original packaging.
Quadramet must be used within 6 hours after thawing. Do not refreeze.
The product label provides the appropriate storage conditions and the expiry date for the product batch. Hospital staff will ensure that the product is stored correctly and that it is not administered beyond the indicated expiry date.
Storage procedures must comply with national regulations for radioactive materials.
6. Package contents and other information
What Quadramet contains
The active substance is Samarium (Sm) lexidronam pentasodium.
Each ml of solution contains 1.3 GBq of Samarium (Sm) lexidronam pentasodium at the reference date (corresponding to 20–80 µg/ml of samarium per vial).
The excipients are total EDTMP (as EDTMP·H₂O), calcium-EDTMP sodium salt (as Ca), total sodium (as Na), water for injections.
Description of the appearance of Quadramet and package contents
Quadramet is an injectable solution.
This product consists of a clear, colourless to light amber solution, supplied in a 15 ml clear glass vial of European Pharmacopoeia type I, closed with a chlorobutyl rubber stopper coated with a Teflon layer and sealed with an aluminium flip-off cap.
Each vial contains between 1.5 ml (2 GBq at reference date) and 3.1 ml (4 GBq at reference date) of injectable solution.
Marketing Authorisation Holder and Manufacturer
CIS bio international
Boîte Postale 32
F-91192 Gif-sur-Yvette cedex
France
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
The following information is intended exclusively for medical professionals or healthcare practitioners:
The complete Product Characteristics Summary of Quadramet is provided in a separate document within the product packaging, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the Product Characteristics Summary (the Product Characteristics Summary must be included in the packaging).