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Important Safety Information

IMFINZI (durvalumab)

Indications and clinical use:

PrIMFINZI® (durvalumab) is indicated for:

  • Treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    • Have disease progression during or following platinum-containing chemotherapy
    • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for IMFINZI please refer to Health Canada’s Notice of Compliance with conditions - drug products web site: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html.

PrIMFINZI® (durvalumab), indicated for:

  • Treatment of patients with resectable muscle invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by adjuvant IMFINZI monotherapy treatment after radical cystectomy
  • Treatment of patients with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy
  • First-line treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumour aberrations in combination with tremelimumab and platinum-based chemotherapy
  • Treatment, as monotherapy, of adult patients with limited-stage small cell lung cancer (LSSCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT)
  • First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin
  • Treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine-based chemotherapy
  • First-line treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who require systemic therapy, in combination with tremelimumab
  • First-line treatment of adult patients with uHCC who require systemic therapy, as monotherapy 
  • In combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR) endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with IMFINZI as monotherapy
  • In combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) (Stage II to IVA)

has been issued market authorization without conditions.

The safety and efficacy of IMFINZI in patients younger than 18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use. 

No overall differences in safety or efficacy were reported between elderly patients (≥65 years of age) and younger patients (<65 years of age). 

Contraindications:

IMFINZI is contraindicated in patients who are hypersensitive to durvalumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most serious warnings and precautions:

Immune-mediated adverse reactions: IMFINZI as monotherapy or in combination with other products can cause severe and fatal immune-mediated adverse reactions, including enterocolitis, intestinal perforation, hepatitis, dermatitis, Stevens-Johnson syndrome, endocrinopathy, pneumonitis, interstitial lung disease, myocarditis, neuropathy, encephalitis, myasthenia gravis, as well as toxicities in other organ systems. Immune-mediated adverse reactions have occurred at higher frequencies when IMFINZI is administered as a combination therapy with tremelimumab compared with IMFINZI as monotherapy.

Other relevant warnings and precautions:

  • Administer under the supervision of healthcare practitioners experienced in the treatment of cancer
  • Infections
  • Infusion-related reactions
  • Fertility
  • Pregnant and breast-feeding women
  • Elderly
  • Serious embolic events in combination with gemcitabine and cisplatin 
  • Driving and operating machinery
  • Hepatic/biliary/pancreatic
  • Monitor AST, ALT, bilirubin, renal, and thyroid function prior to and as indicated based on clinical evaluation

For more information:

Please consult the IMFINZI Product Monograph at https://www.content.astrazeneca.com/ca/en/00620641015302/ePI.html for important information relating to adverse reactions, drug interactions, and dosing, which have not been discussed in this piece.

The Product Monograph is also available by calling us at 1-800-668-6000.

Reference:

  1. IMFINZI Product Monograph. AstraZeneca Canada Inc. February 20, 2026.

IMJUDO (tremelimumab)

Indications & clinical use:

IMJUDO® (tremelimumab for injection) in combination with durvalumab is indicated for the first-line treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) who require systemic therapy.

  • When using IMJUDO in combination with durvalumab, consult Product Monograph for IMFINZI (durvalumab) for further information on this drug.

Evidence from clinical studies and experience suggests there were no overall differences in efficacy between patients 65 years or older and younger patients. Evidence from clinical studies suggests the use in the geriatric population may be associated with differences in safety in the uHCC population.

The safety and effectiveness of IMJUDO in patients younger than 18 years of age have not been established. Therefore, Health Canada has not authorized an indication for pediatric use.

Contraindications:

Hypersensitivity to IMJUDO or any ingredient in the formulation or component of the container.

Most serious warnings and precautions:

Immune-mediated adverse reactions: IMJUDO in combination with durvalumab can cause severe and fatal immune-mediated adverse reactions, including enterocolitis, intestinal perforation, hepatitis, dermatitis, Stevens-Johnson syndrome, endocrinopathy, pneumonitis, interstitial lung disease, myocarditis, neuropathy, encephalitis, myasthenia gravis, as well as toxicities in other organ systems.

Other relevant warnings and precautions:

  • Administer under the supervision of health care professionals experienced in the treatment of cancer
  • When using IMJUDO in combination with durvalumab, consult the IMFINZI (durvalumab) Product Monograph for further information on this drug
  • Driving and operating machinery
  • Lack of clinical data in uHCC for Child-Pugh Class B and C patients
  • May require immunosuppression for imARs
  • Other imARs (i.e., colitis/diarrhea, nephritis, rash, hypothyroidism/hyperthyroidism/thyroiditis, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis/hypopituitarism, other imARs, myasthenia gravis, myositis, polymyositis, Guillain-Barre Syndrome, arthritis, immune thrombocytopenia, pancreatitis, and hypoparathyroidism; immune-checkpoint reactions such as meningitis, demyelination, uveitis, toxic epidermal necrolysis, rhabdomyolysis, hemolytic anemia, sarcoidosis and retinal detachment)
  • Severe infusion-related reactions
  • Monitoring and laboratory tests prior to and as indicated based on clinical evaluations
  • Reproductive health: female and male potential
  • Pregnant and nursing women
  • Pediatric and geriatric populations
  • Renal impairment

For more information:

Please consult the IMJUDO Product Monograph for important information relating to adverse reactions, drug interactions and dosing, which have not been discussed in this piece.

The Product Monograph is also available by calling us at 1-800-668-6000.

References:

  1. IMFINZI Product Monograph. AstraZeneca Canada Inc. February 20, 2026.
  2. IMJUDO Product Monograph. AstraZeneca Canada Inc. June 20, 2025.
  3. Data on File, AstraZeneca Canada Inc. (first CTLA4 PD-L1). November 18, 2025.
  4. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. NEJM Evidence. 2022;1(8) (including Supplementary Appendix and Protocol). doi:10.1056/ EVIDoa2100070.