Finished product reference

Ga68-pentixafor

Injection, Solution · Parenteral · 5 mCi

List code
53551
Pharmacologic class
Diagnostic radiopharmaceutical; gallium-68 labelled CXCR4 chemokine receptor PET tracer (investigational)

What it is and how it works

68Ga-pentixafor is a cyclic pentapeptide that binds with high affinity and selectivity to the human chemokine receptor CXCR4, which is over-expressed in many haematological malignancies and solid tumours and is involved in tumour growth, invasion and metastasis. PET imaging maps CXCR4 expression.

Indications

Investigational PET imaging of CXCR4-expressing diseases, particularly multiple myeloma, lymphomas (including marginal zone and mantle cell lymphoma), leukaemias and primary aldosteronism (aldosterone-producing adenomas), and selection for CXCR4-directed endoradiotherapy; used under clinical research or special-access arrangements.

Dosage and administration (summary)

Dosing is individualised according to the imaging or study protocol and administered by nuclear medicine specialists as a single intravenous injection.

Contraindications

Hypersensitivity to the active substance or excipients.

Warnings and precautions

CXCR4 is also expressed on normal haematopoietic and inflammatory cells, so uptake in bone marrow, spleen and inflamed tissue must be interpreted with care; CXCR4-modulating drugs may alter uptake. Radiation exposure should be kept as low as reasonably achievable.

Pregnancy

Generally avoided in pregnancy because of fetal radiation exposure.

Storage and supply

Prepared on site and used within its short shelf-life (gallium-68 half-life about 68 minutes), kept in appropriate radiation shielding.

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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