Active Ingredient: Samarium ¹⁵³Sm lexidronam
Samarium ¹⁵³Sm lexidronam is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium (99mTc)-labelled biphosphonates on bone scan.
The presence of osteoblastic metastases which take up technetium (99mTc)-labelled biphosphonates should be confirmed prior to therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
37 - 37 mCi per kg of body weight
From 37 To 37 mCi per kg of body weight once every day
The recommended dose of samarium ¹⁵³Sm lexidronam is 37 MBq per kg body weight.
Patients who respond to samarium ¹⁵³Sm lexidronam generally experience the onset of pain relief within 1 week after treatment. Relief of pain may persist for 4 weeks up to 4 months. Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.
Repeat administration of samarium ¹⁵³Sm lexidronam should be based on an individual patient’s response to prior treatment and on clinical symptoms. A minimum interval of 8 weeks should be respected, subject to recovery of adequate bone marrow function.
The data on the safety of repeated dosing are limited and based on compassionate use of the product.
Samarium ¹⁵³Sm lexidronam is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.
Samarium ¹⁵³Sm lexidronam is to be administered by slow intravenous route through an established intravenous line over a period of one minute. Samarium ¹⁵³Sm should not be diluted before use.
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