KEYTRUDA SSI SEPT 24
KEYTRUDA® (pembrolizumab) SELECTED SAFETY INFORMATION
▼ This medicinal product is subject to additional monitoring in Australia due to provisional approval of an extension of indication. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
▼ This medicinal product is subject to additional monitoring in Australia due to provisional approval of an extension of indication. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
KEYTRUDA® (pembrolizumab) SELECTED SAFETY INFORMATION
Precautions
Immune-mediated adverse reactions (ImARs), incl. severe and fatal cases, have occurred in patients receiving KEYTRUDA. These have included, but not limited to: pneumonitis, colitis, hepatitis, hepatotoxicity (in combination with axitinib), nephritis, endocrinopathies (adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous pemphigoid), uveitis, myositis/polymyositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (incl. exacerbation), myelitis, vasculitis, hypoparathyroidism, gastritis, haemolytic anaemia, myocarditis, pericarditis and pericardial effusion, peripheral neuropathy, sclerosing cholangitis, exocrine pancreatic insufficiency, arthritis, solid organ transplant rejection, severe infusion reactions (hypersensitivity, anaphylaxis) and complications of allogeneic HSCT.1
ImARs have occurred after discontinuation of treatment with KEYTRUDA. ImARs can affect more than one body system simultaneously.1
Thyroid and liver function tests should be performed at baseline, periodically during treatment and as indicated based on clinical evaluation.1
Withhold or discontinue KEYTRUDA to manage adverse reactions as described in the Product Information.1
Contraindications
None.1
Adverse Events
Monotherapy: fatigue, pruritus, rash, diarrhoea, nausea, hypothyroidism, hyperthyroidism, pneumonitis, colitis, arthralgia, cough, back pain, vitiligo, abdominal pain, hyponatremia, asthenia, neutropenia, dyspnoea, upper respiratory tract infection, pyrexia, febrile neutropenia, musculoskeletal pain, decreased appetite, constipation, elevated LFTs, urinary tract infection, acute kidney injury, haematuria, sepsis, urosepsis, anaemia, vomiting, increased creatinine, peripheral oedema, pneumonia, weight loss, other laboratory abnormalities, mucosal inflammation, dysphagia, stomatitis, headache, dizziness, peripheral sensory neuropathy, myalgia, neck pain, insomnia, thrombocytopenia, nasopharyngitis, pulmonary embolism, myocarditis, herpes virus infection, oropharyngeal pain, interstitial lung disease, hypersensitivity, infusion reactions, altered mental state, uveitis, thyroiditis, myositis, tumour flare, graft versus host disease (GVHD).1
Combination (where not already listed under Monotherapy) with chemotherapy: nephritis, alopecia, neutrophil count decreased, white blood cell count decreased, infection, thromboembolism, cholangitis, biliary obstruction; with lenvatinib: hypertension, haemorrhagic events, dysphonia, palmar-plantar erythrodysesthesia syndrome, musculoskeletal disorders, proteinuria. Fatal adverse events have occurred; with axitinib : hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia syndrome dysphonia; with chemotherapy and trastuzumab : neutrophil count decreased; (See full PI).1
Interactions
None expected. Avoid systemic corticosteroids or immunosuppressants prior to treatment (except as premedication in combination with chemotherapy).1
Special Populations
Pregnancy/Lactation: Pregnancy Category D. Patients who could become pregnant should use effective contraception during treatment with KEYTRUDA and for at least 4 months following the last dose of KEYTRUDA. There is no information regarding the presence of KEYTRUDA in human milk, the absorption and effects on the breast-fed infant, or the effects on milk production. Advise patients not to breast-feed during treatment and for at least 4 months after the last dose.1
Use in the elderly: No overall differences in safety or efficacy were reported between elderly patients (65+) and younger patients (<65). No dosage adjustment required. Efficacy and safety data from patients ≥ 75 years are limited for combination therapy with pembrolizumab and axitinib in patients with advanced RCC and combination therapy with pembrolizumab and chemotherapy in patients with NSCLC.1
Dosing in renal/hepatic impairment: No dose adjustment required for mild/moderate renal and mild hepatic impairment. KEYTRUDA has not been studied in severe renal or moderate/severe hepatic impairment.1
Machinery operation: Fatigue has been reported with KEYTRUDA treatment so may influence ability to operate machinery/drive.1
Paediatric patients: Efficacy for paediatric patients with melanoma, relapsed or refractory cHL, PMBCL, MSI-H/dMMR cancers, or TMB-H cancers, is extrapolated from the results in the respective adult populations and supported by data from KEYNOTE-051. Efficacy has not been established in other paediatric malignancies.1
Reference: 1. KEYTRUDA Product Information, http://msdinfo.com.au/keytrudapi.
HSCT: Allogeneic Haematopoietic Stem Cell Transplant; LFTs: Liver Function Tests
AU-KEY-01486 v3.0. Issued October 2024.
▼ This medicinal product is subject to additional monitoring in Australia due to provisional approval of an extension of indication. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
KEYTRUDA® (pembrolizumab) SELECTED SAFETY INFORMATION
Precautions
Immune-mediated adverse reactions (ImARs), incl. severe and fatal cases, have occurred in patients receiving KEYTRUDA. These have included, but not limited to: pneumonitis, colitis, hepatitis, hepatotoxicity (in combination with axitinib), nephritis, endocrinopathies (adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous pemphigoid), uveitis, myositis/polymyositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (incl. exacerbation), myelitis, vasculitis, hypoparathyroidism, gastritis, haemolytic anaemia, myocarditis, pericarditis and pericardial effusion, peripheral neuropathy, sclerosing cholangitis, exocrine pancreatic insufficiency, arthritis, solid organ transplant rejection, severe infusion reactions (hypersensitivity, anaphylaxis) and complications of allogeneic HSCT.1
ImARs have occurred after discontinuation of treatment with KEYTRUDA. ImARs can affect more than one body system simultaneously.1
Thyroid and liver function tests should be performed at baseline, periodically during treatment and as indicated based on clinical evaluation.1
Withhold or discontinue KEYTRUDA to manage adverse reactions as described in the Product Information.1
Contraindications
None.1
Adverse Events
Monotherapy: fatigue, pruritus, rash, diarrhoea, nausea, hypothyroidism, hyperthyroidism, pneumonitis, colitis, arthralgia, cough, back pain, vitiligo, abdominal pain, hyponatremia, asthenia, neutropenia, dyspnoea, upper respiratory tract infection, pyrexia, febrile neutropenia, musculoskeletal pain, decreased appetite, constipation, elevated LFTs, urinary tract infection, acute kidney injury, haematuria, sepsis, urosepsis, anaemia, vomiting, increased creatinine, peripheral oedema, pneumonia, weight loss, other laboratory abnormalities, mucosal inflammation, dysphagia, stomatitis, headache, dizziness, peripheral sensory neuropathy, myalgia, neck pain, insomnia, thrombocytopenia, nasopharyngitis, pulmonary embolism, myocarditis, herpes virus infection, oropharyngeal pain, interstitial lung disease, hypersensitivity, infusion reactions, altered mental state, uveitis, thyroiditis, myositis, tumour flare, graft versus host disease (GVHD).1
Combination (where not already listed under Monotherapy) with chemotherapy: nephritis, alopecia, neutrophil count decreased, white blood cell count decreased, infection, thromboembolism, cholangitis, biliary obstruction; with lenvatinib: hypertension, haemorrhagic events, dysphonia, palmar-plantar erythrodysesthesia syndrome, musculoskeletal disorders, proteinuria. Fatal adverse events have occurred; with axitinib : hypertension, hepatotoxicity, palmar-plantar erythrodysesthesia syndrome dysphonia; with chemotherapy and trastuzumab : neutrophil count decreased; (See full PI).1
Interactions
None expected. Avoid systemic corticosteroids or immunosuppressants prior to treatment (except as premedication in combination with chemotherapy).1
Special Populations
Pregnancy/Lactation: Pregnancy Category D. Patients who could become pregnant should use effective contraception during treatment with KEYTRUDA and for at least 4 months following the last dose of KEYTRUDA. There is no information regarding the presence of KEYTRUDA in human milk, the absorption and effects on the breast-fed infant, or the effects on milk production. Advise patients not to breast-feed during treatment and for at least 4 months after the last dose.1
Use in the elderly: No overall differences in safety or efficacy were reported between elderly patients (65+) and younger patients (<65). No dosage adjustment required. Efficacy and safety data from patients ≥ 75 years are limited for combination therapy with pembrolizumab and axitinib in patients with advanced RCC and combination therapy with pembrolizumab and chemotherapy in patients with NSCLC.1
Dosing in renal/hepatic impairment: No dose adjustment required for mild/moderate renal and mild hepatic impairment. KEYTRUDA has not been studied in severe renal or moderate/severe hepatic impairment.1
Machinery operation: Fatigue has been reported with KEYTRUDA treatment so may influence ability to operate machinery/drive.1
Paediatric patients: Efficacy for paediatric patients with melanoma, relapsed or refractory cHL, PMBCL, MSI-H/dMMR cancers, or TMB-H cancers, is extrapolated from the results in the respective adult populations and supported by data from KEYNOTE-051. Efficacy has not been established in other paediatric malignancies.1
Reference: 1. KEYTRUDA Product Information, http://msdinfo.com.au/keytrudapi.
HSCT: Allogeneic Haematopoietic Stem Cell Transplant; LFTs: Liver Function Tests
AU-KEY-01486 v3.0. Issued October 2024.