Hlorek strontu 89srcl2 Polatom

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Strontium Chloride SrCl POLATOM, 37.5 MBq/ml solution for injection

Strontii (Sr) chloridi solutio iniectabilis

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nuclear medicine specialist who is supervising your therapy.
• If you experience any side effects or any side effects not listed in this leaflet, inform your doctor or nuclear medicine specialist who is supervising your therapy.

Table of contents of the leaflet:

• 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 the medicine 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, intended exclusively for therapy, which contains the radioactive isotope strontium-89. Strontium Chloride SrCl POLATOM is used to relieve pain resulting from bone metastases, most often originating from prostate and breast cancer.

2. IMPORTANT INFORMATION BEFORE USING STRONTIUM CHLORIDE SrCl POLATOM

When not to use Strontium Chloride SrCl POLATOM

The preparation should not be administered:

• if the patient has been found to be hypersensitive (allergic) to the active substance or any of the other ingredients of the medicine
• to pregnant or breastfeeding women.

When to exercise special caution when using Strontium Chloride SrCl POLATOM

The use of the radiopharmaceutical Strontium Chloride SrCl POLATOM involves radiation exposure to the patient. However, the radiation dose is the smallest that causes the disappearance of pain symptoms.
Patients who have been previously treated with Strontium Chloride SrCl POLATOM may be given anticancer drugs after blood tests have been performed. It is recommended to maintain an interval of 12 weeks between the use of both treatment methods.
In patients with urinary incontinence, a catheter should be inserted into the bladder for a period of 5 days immediately before the administration of the radiopharmaceutical. The urine produced during this time is radioactive, so all hygiene procedures, especially emptying the urine container, should be performed with particular caution, wearing rubber gloves, to minimize the risk of contamination.
The urine container can be emptied into the municipal sewage system.
The full analgesic effect occurs 10-20 days after the administration of Strontium Chloride SrCl POLATOM.
You should inform the nuclear medicine specialist in the following cases:

• if the woman is pregnant or suspected to be pregnant,
• 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 mainly with urine, after its administration, you should:

• pay special attention to avoiding spillage of urine outside the toilet bowl when urinating,
• wash contaminated clothing separately.

To reduce the risk of urine contamination, it is recommended:

• to urinate in a sitting position (also for men),
• to flush the toilet bowl with water twice after each urination,
• to wash your hands thoroughly after urination,
• to quickly dispose of urine bags,
• to wear rubber gloves when in contact with contaminated clothing, urine containers, etc.

In case of radioactive contamination with urine, wash your hands with cold water, avoiding rubbing them.
After treatment with Strontium Chloride SrCl POLATOM, it is necessary to avoid pregnancy for at least 6 months.

Using the medicine Strontium Chloride SrCl POLATOM with other medicines

Tell your doctor or nuclear medicine specialist who is supervising your therapy about all the medicines you have taken recently, including those that are available without a prescription.
Calcium preparations may reduce the accumulation of strontium-89 in tumor lesions.
Calcium therapy should be discontinued 14 days before the administration of Strontium Chloride SrCl POLATOM.

Using the medicine Strontium Chloride SrCl POLATOM with food and drink

No special precautions are recommended.

Pregnancy and breastfeeding

The medicine should not be administered to pregnant or breastfeeding women.
Before administering the medicine, inform the nuclear medicine specialist if:

• the woman is suspected to be pregnant,
• the woman has not had her menstrual period at the expected time,
• the woman is breastfeeding.

Driving and using machines

Strontium Chloride SrCl POLATOM has no effect on the ability to drive vehicles or operate machinery.

3. HOW TO USE THE MEDICINE STRONTIUM CHLORIDE SrCl POLATOM

Dosage and administration

The nuclear medicine specialist supervising the treatment determines the appropriate dose for the individual patient. 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 the case of an overweight or underweight patient, it is recommended to administer Strontium Chloride SrCl POLATOM at a dose of 2 MBq/kg of lean body mass.
This dose is also recommended for use in elderly patients.
Strontium Chloride SrCl POLATOM is administered as a single intravenous injection.
Hospitalization of the patient is not required, but it is recommended to stay in the nuclear medicine department for the first few hours after the administration of Strontium Chloride SrCl POLATOM.
In the case of recurring pain, it is possible to administer another dose of the radiopharmaceutical after an interval of not less than 3 months from the previous dose, in order to reduce the risk of cumulative toxic effects on the bone marrow. Further administration of the preparation is not recommended in patients who did not respond to the previous dose.

Use in children

The preparation is not intended for use in children.

Administration of a higher dose of the medicine Strontium Chloride SrCl POLATOM

The radiopharmaceutical Strontium Chloride SrCl POLATOM belongs to preparations that are administered under strict medical supervision, exclusively in nuclear medicine departments, by qualified personnel, so the risk of accidental administration is extremely low.
In the event of administration of an excessive amount of radioactive substance, the risk associated with excessive radiation exposure can be reduced by accelerated elimination of the radiopharmaceutical from the body through increased fluid intake and frequent emptying of the bladder.

In case of doubts regarding the use of the medicine Strontium Chloride SrCl POLATOM

contact your doctor or nuclear medicine specialist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Strontium Chloride SrCl POLATOM can cause side effects, although they do not occur in every patient.
An early side effect of Strontium Chloride SrCl is considered to be a transient (lasting up to several days) increase in pain symptoms occurring in some patients, usually within the first few days (most often within 72 hours) after the administration of Strontium Chloride SrCl POLATOM. This symptom may indicate a good response to therapy. These symptoms are usually mild and respond well to the administration of typical painkillers.
A late side effect of Strontium Chloride SrCl administration is a transient suppression of bone marrow function. Usually, a reversible decrease in platelet count is observed, on average by 30% within 4-6 weeks after therapy. After 3-6 months, the platelet count usually returns to the initial values, although the rate of normalization depends on the extent of tumor lesions during therapy. However, in some patients, more severe thrombocytopenia associated with disease progression is observed.
Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor or nuclear medicine specialist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. OTHER INFORMATION

What does the medicine Strontium Chloride SrCl POLATOM contain

• The active substance of the medicine is strontium chloride SrCl [37.5 MBq/ml]
• Other ingredients of the medicine are: sodium chloride, water for injections

What does the medicine Strontium Chloride SrCl POLATOM look like and what does the pack contain

The immediate packaging is a 10 ml glass vial closed with a rubber stopper and an aluminum cap, placed in a lead shielding container. The vial contains a volume of solution corresponding to the activity specified on the day of release.

Marketing authorization holder and manufacturer

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Phone: 22 7180700
Fax: 22 7180350
e-mail: polatom@polatom.pl
To obtain more detailed information, contact your doctor or the representative of the marketing authorization holder.
Date of leaflet approval:April 2016

The following information is intended exclusively for medical personnel or healthcare workers:

A separate document, the Summary of Product Characteristics, has been attached to the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.