Finished product reference
Lutetium (177lu) Dotatate
Injection, Solution · Parenteral · 200 mCi
- List code
- 52643
- Pharmacologic class
- Radiopharmaceutical: lutetium-177-labelled somatostatin analogue (peptide receptor radionuclide therapy)
What it is and how it works
Lutetium (177Lu) oxodotreotide (dotatate) binds with high affinity to somatostatin receptors, particularly subtype 2, which are overexpressed on neuroendocrine tumour cells. After internalisation, the beta emission of lutetium-177 causes DNA damage and death of tumour cells and nearby cells.
Indications
Unresectable or metastatic, progressive, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults (and in adolescents from 12 years where approved).
Dosage and administration (summary)
7.4 GBq by intravenous infusion every 8 weeks for a total of 4 cycles, given with a renal-protective amino acid infusion (L-lysine and L-arginine) and antiemetic premedication, in an authorised nuclear medicine facility; activity is adjusted for toxicity according to protocol.
Contraindications
Established or suspected pregnancy, or when pregnancy has not been excluded; renal failure with creatinine clearance below 30 mL/min; hypersensitivity.
Warnings and precautions
Myelosuppression, myelodysplastic syndrome and acute leukaemia, renal toxicity, hepatotoxicity and neuroendocrine hormonal crises may occur; monitor blood counts, renal and liver function before each cycle. Long-acting somatostatin analogues should be withheld for about 4 weeks before each dose. Radiation-protection measures and effective contraception (for at least 7 months in women and 4 months in men after the last dose) are required; may impair fertility.
Pregnancy
Contraindicated in pregnancy.
Storage and supply
Store below 25 °C in the original lead shielding; do not freeze; use within the expiry time stated (short shelf life).
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
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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