Page 2: Health Product InfoWatch – may 2018

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Product Monograph Updates

The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. A complete list of safety labelling updates for brand name pharmaceutical drugs is available on Health Canada's Web site.

Dipeptidylpeptidase-4 (DPP-4) Inhibitors

The risk of bullous pemphigoid has been included in the Warnings and Precautions and Post-Market Adverse Drug Reactions sections of the Canadian product monographs for DPP-4 inhibitors.^{Footnote *}

Elavil (amitriptyline hydrochloride)

New information regarding the risk of prolongation of the QT interval has been added to the Warnings, Precautions and Adverse Reactions sections of the Canadian product monograph for Elavil.

Gadolinium-Based Contrast Agents (GBCAs)

Additional information related to the potential risk of gadolinium deposition in the brain associated with the use of Gadolinium-Based Contrast Agents (GBCAs) has been included in the Indications and Clinical Use, Warnings and Precautions, and Dosage and Administration sections of the Canadian product monographs for 6 GBCAs.

Imitrex injection (sumatriptan succinate)

The risk of allergic reactions in latex sensitive individuals has been included in the Warnings and Precautions and Consumer Information sections of the Canadian product monograph for Imitrex.

Revlimid (lenalidomide)

The risk of solid organ transplant rejection has been included in the Warnings and Precautions, Adverse Reactions (Post-Market Adverse Drug Reactions), and Consumer Information sections of the Canadian product monograph for Revlimid.

Zydelig (idelalisib)

The risk of progressive multifocal leukoencephalopathy has been included in the Warnings and Precautions, Post-Market Adverse Drug Reactions and Consumer Information sections of the Canadian product monograph for Zydelig (idelalisib).

New Notice of Market Authorization with Conditions section will highlight Health Canada's issuance of Notices of Compliance under the Notice of Compliance with Conditions policy.

Notice of Market Authorization with Conditions

A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the nature of authorization granted.

Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.

The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada, in accordance with the NOC/c Policy. For the most up-to-date information, consult Health Canada's NOC database.

Bavencio (avelumab):Authorization with Conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy for Bavencio^{Footnote *} (avelumab), solution for intravenous infusion 20 mg/mL single-use vial. Bavencio is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy. Patients should be advised about the conditional market authorization for this indication.

For the complete prescribing information and information available for the patients/caregivers, please consult the Bavencio Canadian product monograph. The product monograph can be accessed through Health Canada’s Drug Product Database, the EMD Serono Web site or by contacting EMD Serono, a Division of EMD Inc., Canada at 1-888-737-6668. Contact the company for a copy of any references, attachments or enclosures.

Imfinzi (durvalumab): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy for Imfinzi^{Footnote *} (durvalumab), solution 50 mg/mL, intravenous infusion. Imfinzi is indicated for the treatment of patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. Patients should be advised about the conditional market authorization for this indication.

For the complete prescribing information and information available for the patients/caregivers, please consult the Imfinzi Canadian product monograph. The product monograph can be accessed through: Health Canada’s Drug Product Database, the AstraZeneca Web site or by contacting AstraZeneca Canada Inc., at 1-800-668-6000. Contact the company for a copy of any references, attachments or enclosures.