Strontium chloride 89srcl2 polatom

Strontium Chloride SrCl POLATOM, 37.5 MBq/ml
Solution for injection
Read the entire leaflet carefully before using the medicine.

• Keep this leaflet for future reference.
• Consult your treating physician or the nuclear medicine specialist supervising your therapy if you need advice or further information.
• If any of the side effects worsen, or if you experience any side effects not listed in this leaflet, inform your treating physician or the nuclear medicine specialist supervising your therapy.

Table of contents:

1. What is Strontium Chloride SrCl POLATOM and what is it used for?
2. Important information before using Strontium Chloride SrCl POLATOM.
3. How to use Strontium Chloride SrCl POLATOM.
4. Possible side effects.
5. Other information.

1. WHAT IS STRONTIUM CHLORIDE SrCl POLATOM AND WHAT IS IT USED FOR?

Strontium Chloride SrCl POLATOM is a radiopharmaceutical medicinal product intended exclusively for therapy, containing the radioactive isotope strontium-89. Strontium Chloride SrCl POLATOM is used to relieve pain caused by metastatic cancer, most commonly originating from the prostate gland or breast, that has spread to the bone.

2. IMPORTANT INFORMATION BEFORE ADMINISTRATION OF STRONTIUM CHLORIDE

SrCl POLATOM
When not to use Strontium Chloride SrCl POLATOM
The medicinal product must not be administered:

• if the patient has known hypersensitivity (allergy) to the active substance or to any of the other components of the medicinal product,
• to pregnant or breastfeeding women.

When to exercise special caution when using Strontium Chloride SrCl POLATOM
Administration of the radiopharmaceutical Strontium Chloride SrCl POLATOM involves
exposure of the patient to radiation. However, the radiation dose is the minimum required to achieve
relief from pain symptoms.
Patients previously treated with strontium chloride SrCl POLATOM may receive anticancer
drugs after blood tests have been performed. A 12-week interval between both treatment methods
is recommended.
In patients with urinary incontinence, a urinary catheter should be inserted into the bladder
before administration of the radiopharmaceutical and left in place for 5 days. Urine produced during
this period is radioactive; therefore, all hygiene procedures, especially emptying of the urine
container, must be performed with particular caution and while wearing rubber gloves to minimize
the risk of contamination.
The urine container may be emptied into the municipal sewage system.
Full analgesic effect occurs 10–20 days after administration of Strontium Chloride
SrCl POLATOM.
The nuclear medicine physician should be informed in the following cases:

• if the woman is pregnant or pregnancy is suspected,
• if the woman is breastfeeding,
• if the patient is under 18 years of age.

Important information for the patient after administration of Strontium Chloride SrCl POLATOM
Due to the excretion of Strontium Chloride SrCl POLATOM primarily via urine, the following
precautions should be taken after administration:

• take particular care during urination to avoid spillage outside the toilet bowl,
• wash underwear contaminated with urine separately.

To reduce the risk of contamination by urine, it is advisable to:

• urinate in a sitting position (also for men),
• flush the toilet bowl twice after each urination,
• thoroughly wash hands after urination,
• promptly remove urine collection bags,
• wear rubber gloves when handling contaminated clothing, urine containers, etc.

In case of contamination with radioactive urine, hands should be washed with cold water, avoiding scrubbing.
After treatment with Strontium Chloride SrCl POLATOM, pregnancy must be avoided for at least 6 months.
Use of Strontium Chloride SrCl POLATOM with other medicinal products
Inform the attending physician or the nuclear medicine specialist supervising the therapy about all
medicinal products recently taken, including those available without a prescription.
Calcium preparations may reduce the uptake of strontium-89 in tumor lesions.
Calcium therapy should be discontinued 14 days before administration of strontium chloride SrCl
Use of Strontium Chloride SrCl POLATOM with food and drink
No special precautions are recommended.
Pregnancy and breastfeeding
The medicinal product must not be administered to pregnant or breastfeeding women.
Before administration of the medicinal product, inform the nuclear medicine specialist if:

• pregnancy is suspected,
• menstruation has not occurred at the expected time,
• the woman is breastfeeding.

Driving and operating machinery
Strontium Chloride SrCl POLATOM has no influence on the ability to drive mechanical
vehicles or operate mechanical equipment.

3. HOW TO USE THE MEDICINAL PRODUCT STRONTIUM CHLORIDE SrCl POLATOM

Dosage and method of administration
The appropriate dose suitable for the individual patient is determined by a specialist in nuclear medicine supervising the treatment. This is the smallest amount of the product necessary to achieve the intended therapeutic effect.
The recommended dose of Strontium Chloride SrCl POLATOM corresponds to an activity of 150 MBq.
In patients with overweight or underweight, administration of Strontium Chloride SrCl POLATOM at a dose of 2 MBq/kg of lean body mass is recommended.
This dose is also recommended for elderly patients.
Strontium Chloride SrCl POLATOM is administered as a single intravenous injection.
Hospitalization is not required; however, it is recommended that the patient remain at the nuclear medicine department for the first few hours after administration of Strontium Chloride SrCl POLATOM.
In case of recurrent pain, re-administration of the radiopharmaceutical may be considered no sooner than 3 months after the previous dose, in order to minimize the risk of cumulative bone marrow toxicity. Further administration of the product is not indicated in patients who did not respond to the previous dose.

Use in children
The product is not intended for use in children.

Administration of a higher than recommended dose of Strontium Chloride SrCl POLATOM
The radiopharmaceutical Strontium Chloride SrCl POLATOM belongs to medicinal products administered under strict medical supervision, exclusively in nuclear medicine facilities and by qualified personnel; therefore, the risk of accidental administration is extremely low.
In the event of an overdose of radioactive substance, the risk associated with excessive radiation exposure may be reduced by accelerating elimination of the radiopharmaceutical from the body through increased fluid intake and frequent emptying of the urinary bladder.

If you have any questions regarding the use of Strontium Chloride SrCl POLATOM, please consult your treating physician or a specialist in nuclear medicine.

4. POSSIBLE ADVERSE REACTIONS

Like any medicinal product, Chlorek strontu 89SrCl2 POLATOM may cause adverse reactions,
although they do not occur in everyone.
An early adverse reaction to strontium chloride 89SrCl is transient (lasting up to
several days) worsening of pain symptoms occurring in some patients, usually within
the first few days (most commonly within 72 hours) after administration of Chlorek strontu 89SrCl2 POLATOM.
This symptom may indicate a good response to therapy. These symptoms are
usually mild and respond well to standard analgesic treatment.
A late adverse effect of strontium chloride 89SrCl administration is transient
suppression of bone marrow function. A reversible decrease in platelet count is usually observed,
averaging 30% within 4–6 weeks after therapy. After 3–6 months, platelet counts usually return
to baseline values, although the speed of normalization depends on the extent of tumor lesions present during therapy. However, in some patients, more severe thrombocytopenia associated with disease progression may occur.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your physician or a nuclear medicine specialist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. OTHER INFORMATION

What the medicinal product contains Strontium Chloride SrCl POLATOM

• The active substance is strontium chloride SrCl [37.5 MBq/ml].
• Other components of the medicinal product are: Strontium chloride, Sodium chloride, Water for injections.

What Chlorek strontu SrCl POLATOM looks like and contents of the pack
The immediate packaging consists of a 10 ml glass vial sealed with a rubber stopper and an aluminium cap, placed inside a lead shielding container. The vial contains a volume of solution corresponding to the activity specified on the date of calibration.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]

For more detailed information, please contact your doctor or representative of the Marketing Authorisation Holder.

The following information is intended solely for medical or

healthcare personnel:
The Product Information leaflet has been included in the product packaging as a separate document, to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.