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 *

Key messages for healthcare professionals:Footnote 1Footnote 2Footnote 3Footnote 4Footnote 5Footnote 6Footnote 7Footnote 8

  • Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with the use of DPP-4 inhibitors.
  • In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor.
  • Healthcare professionals should tell their patients to immediately report development of blisters or erosions while receiving a product containing a DPP-4 inhibitor. If bullous pemphigoid is suspected, this product should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

References

Footnote 1

Glyxambi (empagliflozin and linagliptin) [product monograph]. Burlington (ON): Boehringer Ingelheim (Canada) Ltd.; 2017.

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Footnote 2

Janumet, Janumet XR (sitagliptin and metformin) [product monograph]. Kirkland (QC): Merck Canada Inc.; 2017.

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Footnote 3

Januvia (sitagliptin) [product monograph]. Kirkland (QC): Merck Canada Inc.; 2017.

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Footnote 4

Kazano (alogliptin and metformin) [product monograph]. Oakville (ON): Takeda Canada Inc.; 2018.

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Footnote 5

Komboglyze (saxagliptin and metformin) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2018.

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Footnote 4

Nesina (alogliptin) [product monograph]. Oakville (ON): Takeda Canada Inc.; 2018.

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Footnote 7

Onglyza (saxagliptin) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2018.

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Footnote 8

Qtern (saxagliptin and dapagliflozin) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2018.

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Footnote *

The Canadian product monographs for Jentadueto (linagliptin and metformin) and Trajenta (linagliptin) already contained information on the risk of bullous pemphigoid.

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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.

Key messages for healthcare professionals:Footnote 9

  • Cases of QT interval prolongation and arrhythmia have been reported with the use of amitriptyline during the post-marketing period.
  • Amitriptyline should be used with caution in patients with significant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QT-prolonging drugs, methadone, or diuretics inducing hypokalemia.
  • Electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesaemia) are also known to increase the proarrythmic risk in patients taking amitriptyline.
  • Concurrent administration of amitriptyline and electroconvulsive therapy may increase the hazards of therapy.

Reference

Footnote 9

Elavil (amitriptyline hydrochloride) [product monograph]. Vaughan (ON): AAPharma Inc.; 2018

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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.

Key messages for healthcare professionals:Footnote 10Footnote 11Footnote 12Footnote 13Footnote 14Footnote 15

  • Use of macrocyclic agents may be preferable in certain patients such as those for whom repeated GBCA doses may need to be considered due to individual clinical circumstances and in other potentially vulnerable patients such as children and pregnant women.

References

Footnote 10

Dotarem (gadoterate meglumine) [product monograph]. Roissy-en-France (France): Guerbet; 2018.

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Footnote 11

Gadovist (gadobutrol) [product monograph]. Mississauga (ON): Bayer Inc.; 2018.

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Footnote 12

Magnevist (gadopentetate dimeglumine) [product monograph]. Mississauga (ON): Bayer Inc.; 2018.

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Footnote 13

Multihance (gadobenate dimeglumine) [product monograph]. Montréal (QC): Bracco Imaging Canada; 2018.

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Footnote 14

Omniscan (gadodiamide) [product monograph]. Mississauga (ON): GE Healthcare Canada Inc.; 2018.

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Footnote 15

Prohance (gadoteridol) [product monograph]. Montréal (QC): Bracco Imaging Canada; 2018.

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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.

Key messages for healthcare professionals:Footnote 16

  • The needle shield of Imitrex pre-filled syringe contains dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.

Reference

Footnote 16

Imitrex injection (sumatriptan succinate) [product monograph]. Mississauga, (ON): GlaxoSmithKline Inc.; 2018

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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.

Key messages for healthcare professionals:Footnote 17

  • Cases of solid organ transplant (SOT) rejection have been reported in the post-market setting with the use of Revlimid and, in some cases, have resulted in a fatal outcome.
  • Onset of SOT rejection may be acute, occurring within 1 to 3 cycles of Revlimid treatment.
  • The benefit of treatment with Revlimid versus the risk of possible SOT rejection should be considered in patients with a history of SOT before initiating Revlimid therapy.
  • Clinical and laboratory signs of SOT rejection should be closely monitored such as flu-like symptoms (fever, chill, body ache, nausea, cough, shortness of breath, feeling unwell or tired), pain at the area of transplant, less urine, sudden weight gain or other possible symptoms specific to the type of transplant. Revlimid therapy should be discontinued in the event of SOT rejection.

Reference

Footnote 16

Revlimid (lenalidomide) [product monograph]. Mississauga (ON): Celgene Inc.; 2018.

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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).

Key messages for healthcare professionals:Footnote 18

  • Cases of progressive multifocal leukoencephalopathy (PML) have been reported following the use of Zydelig within the context of prior- or concomitant immunosuppressive therapies that have been associated with PML.
  • Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms. If PML is suspected then appropriate diagnostic evaluations should be undertaken and treatment suspended until PML is excluded.
  • If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessments should be considered.
  • Discontinue Zydelig permanently in patients with confirmed PML.

Reference

Footnote 18

Zydelig (idelalisib) [product monograph]. Mississauga, (ON): Gilead Sciences Canada, Inc.; 2018.

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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 BavencioFootnote * (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.

Footnote *1

Bavencio has a previous product monograph dated December 2017; the product monograph including this NOC/c indication is dated May 2018.

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Imfinzi (durvalumab): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy for ImfinziFootnote * (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.

Footnote *2

Imfinzi has a previous product monograph dated November 2017; the product monograph including this NOC/c indication is dated May 2018.

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