Finished product reference
Lutetium (177lu) Edtmp
Kit · Parenteral · 50 mg
- List code
- 53571
- Pharmacologic class
- Radiopharmaceutical kit: preparation of lutetium-177 EDTMP (bone-seeking agent)
What it is and how it works
The kit contains ethylenediamine tetramethylene phosphonic acid (EDTMP), a phosphonate chelator, for radiolabelling with lutetium-177 chloride. The resulting complex localises in areas of increased osteoblastic activity in bone, where lutetium-177 beta emission irradiates skeletal metastases and relieves bone pain.
Indications
Palliation of pain from osteoblastic or mixed skeletal metastases (e.g. prostate and breast cancer) confirmed by bone scintigraphy.
Dosage and administration (summary)
After radiolabelling according to the kit instructions, administered by slow intravenous injection in a nuclear medicine facility; activity is individualised according to protocol and body weight.
Contraindications
Pregnancy and breast-feeding; significant pre-existing bone-marrow suppression; hypersensitivity.
Warnings and precautions
Transient myelosuppression (thrombocytopenia and leucopenia) may occur; monitor blood counts for several weeks. A temporary increase in bone pain (flare) can occur after injection. Ensure adequate hydration and frequent voiding to reduce bladder radiation dose; radiation-protection precautions are required.
Pregnancy
Contraindicated in pregnancy.
Storage and supply
Store the unlabelled kit according to the manufacturer’s instructions; handle the labelled product in lead shielding in compliance with radiation-protection regulations.
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.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.