Finished product reference
Samarium (Sup153/Supsm) Lexidronam
Injection, Solution · Parenteral · 80 mCi · 80 mCi
- List code
- 51101
- Pharmacologic class
- Therapeutic radiopharmaceutical (bone-seeking; samarium-153 lexidronam/EDTMP)
What it is and how it works
Samarium-153 lexidronam (153Sm-EDTMP) is a phosphonate chelate that localises in bone in proportion to osteoblastic activity, concentrating at sites of skeletal metastases. Samarium-153 emits beta particles that irradiate these sites and gamma photons suitable for imaging; its half-life is about 46 hours.
Indications
Relief of bone pain in patients with multiple painful osteoblastic skeletal metastases shown on bone scintigraphy.
Dosage and administration (summary)
Dosing is individualised according to protocol by nuclear medicine specialists; the usual regimen is a single slow intravenous injection based on body weight (about 37 MBq/kg), which may be repeated after haematological recovery.
Contraindications
Pregnancy, recent myelosuppressive chemotherapy or radiotherapy, and severe bone marrow suppression.
Warnings and precautions
Causes dose-related transient bone marrow suppression (nadir at about 3–5 weeks), so monitor blood counts weekly for at least 8 weeks; a transient flare of bone pain may occur. Patients should be well hydrated and void frequently, and radiation-protection precautions apply to urine for several hours after injection.
Pregnancy
Therapeutic radiopharmaceuticals are contraindicated in pregnancy; pregnancy must be excluded before administration.
Storage and supply
Supplied frozen; store frozen in lead shielding according to the manufacturer, thaw before use and do not refreeze; use within the stated time after thawing.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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