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Important safety information for TRUQAP

Clinical use:

No pediatric data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

Safety analyses suggest a higher incidence of severe adverse reactions in those >65 years of age compared to younger patients.

Contraindications:

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

Most serious warnings and precautions:

Cutaneous adverse reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Erythema Multiforme (EM) and palmar-plantar erythrodysesthesia. Patients should be monitored for signs and symptoms of cutaneous reactions and based on severity, TRUQAP dosing may be interrupted, reduced, or permanently discontinued. Early consultation with a dermatologist is recommended.

Hyperglycemia, including diabetic ketoacidosis. Some cases have been fatal. Patients must be tested for fasting blood glucose (FG) levels and HbA1c prior to treatment with TRUQAP and at regular intervals during treatment. Blood glucose should be optimized prior to initiation of treatment. Before initiating treatment with TRUQAP, patients should be informed about the potential of TRUQAP to cause hyperglycemia, and to contact their healthcare professional immediately if hyperglycemia symptoms occur. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia. Based on the severity of hyperglycemia, TRUQAP dosing may be interrupted, reduced, or permanently discontinued.

Severe diarrhea associated with dehydration and acute kidney injury. Advise patients to start antidiarrheal treatment at the first sign of diarrhea and to increase oral fluids if diarrhea symptoms occur while taking TRUQAP. Based on the severity of diarrhea, TRUQAP may be interrupted, reduced, or permanently discontinued.

Other relevant warnings and precautions:

  • Caution when driving or operating machinery
  • Testing for fasting blood glucose (FG) levels and HbA1c
  • Monitoring of ketones and other metabolic parameters
  • Use effective contraception during treatment and for at least 4 weeks after completion of treatment with TRUQAP
  • Rule out pregnancy before treatment and avoid becoming pregnant
  • Do not breastfeed
  • Teratogenic risk

For more information:

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

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

References:

  1. TRUQAP Product Monograph. AstraZeneca Canada Inc. January 3, 2025.
  2. Burstein HJ, et al. Endocrine and Targeted Therapy for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer—Capivasertib-Fulvestrant: ASCO Rapid Recommendation Update. J Clin Oncol 2024;42:1450-1453.
  3. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Breast Cancer. Version 4.2024 July 3, 2024.
  4. Turner NC, et al. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388(22):2058-2070.
  5. Data on file.
  6. Data on file.
  7. Data on file.
  8. Data on file.
  9. Data on file.
  10. FASLODEX Product Monograph. AstraZeneca Canada Inc. November 15, 2019.
  11. Rugo HS, et al. Capivasertib and fulvestrant for patients with hormone receptor-positive advanced breast cancer: characterization, time course, and management of frequent adverse events from the phase III CAPItello-291 study. ESMO Open 2024;9(9):103697.
  12. ClinicalTrials.gov. Capivasertib + CDK4/6i + fulvestrant for advanced/metastatic HR+/HER2- breast cancer (CAPItello-292) (CAPItello-292) ClinicalTrials.gov ID NCT04862663.
    Available at: https://clinicaltrials.gov/study/NCT04862663?term=capivasertib&page=2&rank=11 (accessed October 1, 2024).
  13. ClinicalTrials.gov. A Phase 1b Study of T-DXd combinations in HER2-low advanced or metastatic breast cancer (DB-08) ClinicalTrials.gov ID NCT04556773.
    Available at: https://clinicaltrials.gov/study/NCT04556773?term=capivasertib&page=3&rank=24 (accessed October 1, 2024).
  14. ClinicalTrials.gov. Study of capivasertib + docetaxel vs placebo + docetaxel as treatment for metastatic castration resistant prostate cancer (mCRPC) (CAPItello280) ClinicalTrials.gov ID NCT05348577. Available at: https://clinicaltrials.gov/study/NCT05348577?term=capivasertib&page=2&rank=15 (accessed October 1, 2024).
  15. ClinicalTrials.gov. Study of capivasertib in relapsed or refractory B-cell Non-Hodgkin Lymphoma (CAPITAL) ClinicalTrials.gov ID NCT05008055.
    Available at: https://clinicaltrials.gov/study/NCT05008055?term=capivasertib&rank=2 (accessed October 1, 2024).