Notice to stakeholders: Harmonizing fludeoxyglucose (F-18 FDG) product monographs

Health Canada recommends modified wording for the indications and clinical uses of fludeoxyglucose (F-18 FDG) products in their product monographs. The modified wording aims to bring the indications and clinical uses for F-18 FDG up-to-date and harmonize the product monographs in this regard.

Issues with fludeoxyglucose (F-18 FDG) product monographs

Stakeholders from industry and academia have indicated to Health Canada:

concerns regarding the inconsistent presentation of the indications and clinical uses for F-18 FDG products
interest in adding all common uses of F-18 FDG to the product monographs of all the F-18 FDG products

Furthermore, there are a number of indications and uses that are not captured in the product monograph of each F-18 FDG product.

Recommended wording to harmonize F-18 FDG product monographs

There is a need to bring the indications, as currently written in the various product monographs for several F-18-FDG products, in line with each other. To achieve this, we have provided recommended wording.

For all F-18 FDG radiopharmaceuticals, the indications are:
- F-18 FDG is to be used only for diagnostic purposes with Positron Emission Tomography (PET).
- F-18 FDG helps in the diagnosis of the diseases as noted below based on the changed uptake of F-18 FDG due to altered tissue metabolism.
For all F-18 FDG products currently authorized for the diagnosis and follow-up of lung cancer, the recommended wording is:
- F-18 FDG is indicated for the diagnosis and differential diagnosis of pulmonary nodule or nodules. Lesions 1 cm or less in size may not be evaluable or distinguishable. Malignant lesions may have to be differentiated from inflammatory, granulomatous and arteriosclerotic lesions.
- When used for the diagnosis of malignant lung diseases, F-18 FDG can provide information on the nature of the cancer (small vs non-small cell lung cancer), staging of the disease, recurrence and monitoring of therapeutic activity.
- Some tumors with low glycolytic activity may show a false negative scan.
For those products where colon cancer is also an authorized indication, the recommended wording is:
- F-18 FDG is indicated for the evaluation of colorectal cancer, for recurrence, restaging and detection of distant metastases.
- Some non-cancerous lesions and inflammatory areas such as post-surgical or post-radiation inflammation, colonic adenomas and bladder diverticulae, as well as lesion size (1 cm or less), may be confounders and should be carefully ruled out.
For those F-18 FDG products where breast cancer is also part of the indications, the recommended wording is:
- F-18 FDG is indicated for the evaluation of recurrence, residual disease, distant metastases, staging and restaging, and therapeutic monitoring. As with other tumors, it is advised to rule out inflammatory and other lesions as potential confounders.
For those F-18 FDG products that are indicated for the diagnosis of cardiac disease, the recommended wording is:
- F-18 FDG is indicated in the evaluation of patients with coronary artery disease and severe left ventricular dysfunction, or when other conventional imaging modalities are unlikely to contribute to the diagnostic assessment or when these have been equivocal, or non-conclusive (e.g. echocardiography or SPECT imaging).
- F-18 FDG is best used in conjunction with myocardial perfusion imaging to help define myocardial viability in patients with dysfunctional, hypo-perfused myocardial regions. F-18 FDG imaging may help identify metabolic activity that is still persistent in what is considered dysfunctional and hypo-perfused myocardial regions.

Changes are recommended for any current and future indications.

Current indications

Sponsors may include all current indications in the product monograph, should they desire.
Sponsors can amend current indications by filing a Labelling Only Submission.
When filing a Labeling Only Submission to amend current indications, we recommend that sponsors refer to this notice in their submissions and that no data be included within a Labelling Only Submission.
For F-18 FDG products that were authorized under the Abbreviated New Drug Submission (ANDS) pathway of the draft guidance for industry, sponsors can only update the indications in their product monograph if the Canadian Reference Product has updated their indications accordingly.

Future indications

Any future indication not listed under current indications will be:

at the discretion of each sponsor
based on the filing of supplements to their current submissions, or New Drug Submissions.

Health Canada will provide further guidance. In the meantime, sponsors are encouraged to seek advice from the Biologic and Radiopharmaceutical Drugs Directorate in this regard.

Updating 18F-FDG product monographs under 2020 guidance

Sponsors are expected to update product monographs under the 2020 guidance and format if they are filed to Health Canada as part of a submission. Details about this requirement are found in the notice published on May 12, 2020 regarding product monograph implementation plans.

Effective date

The recommended modified wording is effective as of the publication of this Notice.

Please contact the Biologic and Radiopharmaceutical Drugs Directorate for further guidance and clarification.

Contact information

For any general questions regarding this notice, please contact:

Office of Policy and International Collaboration
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney's Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B
hc.bgtd.opic-bpci.dpbtg.sc@canada.ca

For any questions regarding changes to a particular product monograph, please contact:

Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney's Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601C
hc.bgtd.ora.sc@canada.ca

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Date modified:: 2021-01-06

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