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Metastron

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Metastron

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INDICATIONS

Metastron (Strontium-89 Chloride Injection) is indicated for the relief of bone pain in patients with painful skeletal metastases.

The presence of bone metastases should be confirmed prior to therapy.

DOSAGE AND ADMINISTRATION

The recommended dose of Metastron (strontium-89) is 148 MBq, 4 mCi, administered by slow intravenous injection (1-2 minutes). Alternatively, a dose of 1.5 - 2.2 MBq/kg, 40-60 μCi/kg body weight may be used.

Repeated administrations of Metastron (strontium-89) should be based on an individual patient's response to therapy, current symptoms, and hematologic status, and are generally not recommended at intervals of less than 90 days.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Radiation Dosimetry

The estimated radiation dose that would be delivered over time by the intravenous injection of 37 MBq, 1 mCi of Strontium-89 to a normal healthy adult is given in Table 4.

Data are taken from the ICRP publication “Radiation Dose to Patients from Radiopharmaceuticals”-ICRP #53, Vol. 18, No. 1- 4, Page 171, Pergamon Press, 1988.

Table 4: Strontium-89 Dosimetry

Organ mGy/MBq rad/mCi
Bone Surface 17.0 63.0
Red Bone Marrow 11.0 40.7
Lower Bowel Wall 4.7 17.4
Bladder Wall 1.3 4.8
Testes 0.8 2.9
Ovaries 0.8 2.9
Uterine Wall 0.8 2.9
Kidneys 0.8 2.9

When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with correspondingly higher doses to the metastases compared with normal bones and other organs.

The radiation dose hazard in handling Strontium-89 Chloride injection during dose dispensing and administration is similar to that from phosphorus-32. The beta emission has a range in water of about 8 mm (max.) and in glass of about 3 mm, but the bremsstrahlung radiation may augment the contact dose.

Measured values of the dose on the surface of the unshielded vial are about 65 mR/minute/mCi.

It is recommended that the vial be kept inside its transportation shield whenever possible.

HOW SUPPLIED

Metastron (strontium-89) is supplied in a 10 mL vial containing 148 MBq, 4 mCi. The vial is shipped in a transportation shield with approximately 3 mm lead wall thickness, package insert, and two therapeutic agent warning labels.

The vial and its contents should be sto red inside its transportation container at room temperature 15°-25°C (59°-77°F).

The calibration date (for radioactivity content) and expiration date are quoted on the vial label. The expiration date will be 28 days after calibration. Stability studies have shown no change in any of the product characteristics monitored during routine product quality control over the period from manufacture to expiration.

This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Illinois Adm. Code 330.260 (a) and Part 335 Subpart F.335.5010 or under equivalent licenses of the USNRC or an Agreement State.

NDC 17156-524-01

Manufactured by: GE Healthcare Ltd., Amersham, England. GE Healthcare, Medi-Physics, Inc., 3350 North Ridge Avenue, Arlington Heights, IL 60004. Revised February 2006. FDA revision date: 8/24/1999

Last reviewed on RxList: 1/29/2009
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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