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SAMARIUM CATION SM-153

2128O9F90Y

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Status:

US Previously Marketed

First approved in 1997

Class (Stereo):

CHEMICAL (ACHIRAL)

Conditions:

Samarium SM-153 lexidronam is a chelated complex of a radioisotope of the element samarium with ethylenediamine tetra(methylene phosphonic acid) (EDTMP). Samarium Sm-153 EDTMP has an affinity for bone and concentrates in areas of bone turnover in ass...

ociation with hydroxyapatite. In clinical studies employing planar imaging techniques, more Samarium (153Sm) lexidronam accumulates in osteoblastic lesions than in normal bone with a lesion-to-normal bone ratio of approximately 5. It is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. It should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. The most common adverse events are: nausea and vomiting, hemoglobin decrease, myasthenia, paresthesia, thrombocytopenia and abdominal pain.

SAMARIUM CHLORIDE SM-153

9B6QP3540H

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Status:

US Previously Marketed

First approved in 1997

Class (Stereo):

CHEMICAL (ACHIRAL)

Conditions:

Samarium SM-153 lexidronam is a chelated complex of a radioisotope of the element samarium with ethylenediamine tetra(methylene phosphonic acid) (EDTMP). Samarium Sm-153 EDTMP has an affinity for bone and concentrates in areas of bone turnover in ass...

ociation with hydroxyapatite. In clinical studies employing planar imaging techniques, more Samarium (153Sm) lexidronam accumulates in osteoblastic lesions than in normal bone with a lesion-to-normal bone ratio of approximately 5. It is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. It should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. The most common adverse events are: nausea and vomiting, hemoglobin decrease, myasthenia, paresthesia, thrombocytopenia and abdominal pain.

SAMARIUM SM-153 LEXIDRONAM

745X144DZY

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Status:

US Previously Marketed

First approved in 1997

Class (Stereo):

CHEMICAL (ACHIRAL)

Conditions:

Samarium SM-153 lexidronam is a chelated complex of a radioisotope of the element samarium with ethylenediamine tetra(methylene phosphonic acid) (EDTMP). Samarium Sm-153 EDTMP has an affinity for bone and concentrates in areas of bone turnover in ass...

ociation with hydroxyapatite. In clinical studies employing planar imaging techniques, more Samarium (153Sm) lexidronam accumulates in osteoblastic lesions than in normal bone with a lesion-to-normal bone ratio of approximately 5. It is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. It should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. The most common adverse events are: nausea and vomiting, hemoglobin decrease, myasthenia, paresthesia, thrombocytopenia and abdominal pain.

SAMARIUM SM-153 LEXIDRONAM PENTASODIUM

7389YR3OOV

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Status:

US Previously Marketed

First approved in 1997

Class (Stereo):

CHEMICAL (ACHIRAL)

Conditions:

Samarium SM-153 lexidronam is a chelated complex of a radioisotope of the element samarium with ethylenediamine tetra(methylene phosphonic acid) (EDTMP). Samarium Sm-153 EDTMP has an affinity for bone and concentrates in areas of bone turnover in ass...

ociation with hydroxyapatite. In clinical studies employing planar imaging techniques, more Samarium (153Sm) lexidronam accumulates in osteoblastic lesions than in normal bone with a lesion-to-normal bone ratio of approximately 5. It is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan. It should not be given concurrently with chemotherapy or external beam radiation therapy unless the benefit outweighs the risks. The most common adverse events are: nausea and vomiting, hemoglobin decrease, myasthenia, paresthesia, thrombocytopenia and abdominal pain.

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