NETVision®

(gallium (68Ga) oxodotreotide injection)

This information is intended only for Healthcare Professionals in Canada. Canadian regulations limit the scope of information we can provide to the public for marketed products. If you are a member of the public and have any questions about this product, please consult a qualified healthcare professional for further information.

NETVision® (gallium (68Ga) oxodotreotide injection) is a marketed diagnostic radiopharmaceutical used to non-invasively detect and localize somatostatin receptor (SSTR)-positive neuroendocrine tumours (NETs). The agent is used with positron emission tomography (PET) as an adjunct to other diagnostic tests (e.g. Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI)).

Neuroendocrine tumours (NETs) are the second most common neoplasm of the diffuse endocrine system and are a diverse and uncommon group of malignancies with an incidence of approximately 2 – 6/100,000 in Canada. NETVision® exploits the overexpression of SSTRs as a specific target for diagnostic purposes and for localization of NETs, including in the gastroenteropancreatic tract, respiratory system, thyroid, and presenting as pheochromocytomas and paraganglioma.

Product Information

Indications and Clinical Use

NETVision® (gallium (68Ga) oxodotreotide injection) is indicated for use with positron emission tomography (PET), as an adjunct to other diagnostic tests, for the detection and localization of somatostatin receptor-positive neuroendocrine tumours (NETs).

Description

Route of Administration:

  • Intravenous

Dosage Form/Strength/Composition:

  • Solution for Injection
  • ≤ 122 MBq/mL (radioactive strength at end of synthesis)
  • ≤ 50 μg 68Ga-oxodotreotide peptide (chemical dose)

Non-medicinal Ingredients:

  • Phosphate-buffered saline, ≤ 10% ethanol

Contraindications

  • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the NETVision® Product Monograph (Section 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
  • Patients who are taking disulfiram (Antabuse)

Serious Warnings and Precautions

  • NETVision® should be used only by those health professionals who are appropriately qualified in the use of radioactive prescribed substances in or on humans.

Special Populations

(refer to the NETVision® Product Monograph, Section 7 SPECIAL POPULATIONS for further details)

  • The safety and efficacy of NETVision® in pediatric patients (< 18 years of age) have not been established.
  • NETVision® studies in geriatric patients (> 65 years of age) do not provide sufficient numbers of subjects to determine whether they respond differently from younger subjects.
  • NETVision® studies have not been performed with pregnant women. The benefits to be gained and the potential hazards to the fetus should be considered prior to administering the product.
  • NETVision® is excreted in human breast milk. To avoid unnecessary irradiation of the infant, formula feeding should be substituted temporarily for breast-feeding.

Expiration

5 hours post end-of-synthesis

Availability

Monday – Friday.

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