KEYTRUDA® is indicated for:
- Treatment of adult patients with high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
- Treatment in combination with chemotherapy for adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test.
For more information, please consult:
Product MonographClinical Trials
KEYNOTE-355 (clinical study in locally recurrent unresectable or metastatic TNBC)
Keynote-355KEYNOTE-522 (clinical study in high-risk, early-stage TNBC)
Keynote-522Clinical use:
Geriatrics (>65 years of age): No overall differences in safety or efficacy were reported between elderly patients (65 years and over) and younger patients (less than 65 years).
Relevant warnings and precautions:
- Immune-mediated adverse reactions, including severe and fatal cases
- Pneumonitis
- Colitis
- Hepatitis
- Nephritis and renal dysfunction
- Endocrinopathies including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus and thyroid disorders
- Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
- Other immune-mediated adverse events including uveitis, arthritis, myositis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis, vasculitis, Guillain-Barré syndrome, hemolytic anemia, pancreatitis, myelitis, myocarditis, hypoparathyroidism, sclerosing cholangitis
- Solid organ transplant rejection
- Allogeneic hematopoietic stem cell transplant after and before treatment
- Severe infusion-related reactions
- Teratogenic risk
- Women should avoid pregnancy and breastfeeding during treatment and for at least 4 months after it
- Monitoring requirements
- Patients with hepatic impairment
- Renal impairment
- Driving and operating machinery
- Pediatrics <18 years of age
- Geriatrics
For more information:
Please consult the Product Monograph for important information regarding adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-567-2594 or by email at medinfocanada@merck.com
Explore tools and resources for you and your TNBC patients.
KEYTRUDA® RESOURCESReference
1. Merck Canada Inc. KEYTRUDA® Product Monograph. January 25, 2022.
CA-PDO-00144