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VARIOUS › DIAGNOSTIC RADIOPHARMACEUTICALS › TUMOUR DETECTION › Other diagnostic radiopharmaceuticals for tumour detection
gallium (68Ga) gozetotide
V09IX14
Forms & Strengths
- 68Ga‑gozetotide solution for IV injection, supplied in single‑use vials
- Kit for onsite labeling with 68Ga generator
- Typical activity 100–200 MBq (2.7–5.4 mCi) per dose
Adult Dosing
- IV injection of 100–200 MBq (2.7–5.4 mCi) of 68Ga‑gozetotide
- Administer 60 minutes before PET acquisition
- Maximum single administration 200 MBq; repeat imaging not sooner than 4 weeks
- For patients >100 kg, consider up to 250 MBq based on body habitus
Pediatric Dosing
- No routine pediatric indication; if required, use weight‑based dose 1.5 MBq/kg (max 100 MBq)
- Limited safety data; reserve for clinical trials
Indications
- PET imaging of PSMA‑positive prostate cancer for initial staging
- Detection of biochemical recurrence of prostate cancer
- Restaging and assessment of metastatic disease
- Off‑label evaluation of PSMA expression in other solid tumors
Mechanism of Action
- 68Ga is chelated to the PSMA‑11 ligand (gozetotide) that binds with high affinity to prostate‑specific membrane antigen (PSMA) on malignant prostate cells
- Ligand‑receptor complex is internalized, concentrating 68Ga at tumor sites
- Positron emission from 68Ga enables high‑resolution PET imaging
Contraindications
- Pregnancy or lactation due to ionizing radiation exposure
- Known hypersensitivity to gozetotide or any excipient
- Severe renal impairment (eGFR <30 mL/min) that would markedly reduce clearance
- Inability to remain still for the duration of PET acquisition
Adverse Reactions
- Mild injection‑site pain or erythema
- Transient nausea or vomiting
- Headache
- Allergic manifestations (rash, urticaria, rare anaphylaxis)
- Low‑dose radiation‑related effects (theoretical risk)
Drug Interactions
- Concurrent radiopharmaceuticals increase cumulative radiation dose – avoid unless clinically justified
- Medications that modulate PSMA expression (e.g., androgen deprivation therapy) may alter tracer uptake
- Renal‑clearing agents (e.g., loop diuretics) can affect excretion but no major clinical impact
- No significant cytochrome P450 or pharmacodynamic interactions
Curated Content: Needs Vetting Before Put to Clinical Use