Working with your patients to enhance their treatment pathway

Dr Gary Doherty, Consultant Medical Oncologist, Cambridge University Hospitals NHS Foundation Trust

Ms Rachel Powell, Advanced Clinical Practitioner, University of Birmingham Hospitals NHS Foundation Trust

Consult SmPC for further information and detail, including adverse events and management. Note: ILD, severe cutaneous adverse reactions, QTc interval prolongation and changes in cardiac contractility, keratitis, and aplastic anaemia are special warnings for Tagrisso.
1. Tagrisso. Summary of Product Characteristics.

GB-57396
Date of Preparation: January 2025

Tagrisso safety profile summary:

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Adverse reactions reported	TAGRISSO		TAGRISSO with pemetrexed and platinum-based chemotherapy
Adverse reactions reported	CIOMS descriptor/ overall frequency (all CTCAE grades)	Frequency of CTCAE grade 3 or higher	CIOMS descriptor/ overall frequency (all CTCAE grades)	Frequency of CTCAE grade 3 or higher
Blood and lymphatic system disorders
Aplastic anaemia	Rare (0.06%)	0.06%	0%	0%
Leukopenia	Common (5.4%)	0.4%	Very common (12.7%)	2.9%
Lymphopenia	Common (1.7%)	0.2%	Common (2.5%)	1.1%
Thrombocytopenia	Common (7.6%)	0.6%	Very common (18.5%)	6.9%
Neutropenia	Common (6%)	0.9%	Very common (24.6%)	13.4%
Metabolism and nutrition disorders
Decreased appetite	Very common (19%)	1.2%	Very common (31%)	2.9%
Eye disorders
Keratitis	Uncommon (0.6%)	0.06%	Uncommon (0.7%)	0%
Cardiac disorders
Cardiac failure	Uncommon (0.5%)	0.2%	Common (1.8%)	1.1%
Respiratory, thoracic and mediastinal disorders
Epistaxis	Common (6%)	0%	Common (7%)	0.4%
Interstitial lung disease	Common (4.0%)	1.4%	Common (3.3%)	0.7%
Gastrointestinal disorders
Diarrhoea	Very common (47%)	1.4%	Very common (43%)	2.9%
Stomatitis	Very common (24%)	0.4%	Very common (31%)	0.4%
Skin and subcutaneous tissue disorders
Rash	Very common (46%)	0.8%	Very common (49%)	2.5%
Paronychia	Very common (34%)	0.4%	Very common (27%)	0.7%
Dry skin	Very common (32%)	0.1%	Very common (24%)	0%
Pruritus	Very common (17%)	0.06%	Common (8%)	0%
Alopecia	Common (5%)	0%	Common (9%)	0%
Palmar-plantar erythrodysaesthesia syndrome	Common (2.1%)	0%	Common (5%)	0%
Urticaria	Common (1.9%)	0.1%	Common (1.4%)	0.4%
Skin hyperpigmentation	Common (1.0%)	0%	Common (2.5%)	0%
Erythema multiforme	Uncommon (0.3%)	0%	Common (1.4%)	0.7%
Cutaneous vasculitis	Uncommon (0.2%)		0%	0%
Stevens-Johnson syndrome	Rare (0.02%)		0%	0%
Toxic Epidermal Necrolysis	Not known		0%	0%
Investigations
Left ventricular ejection fraction decreased	Common (4.2%)		Common (8%)
QTc interval prolongation	Common (1.1%)		Common (1.8%)
Blood creatine phosphokinase increased	Common (1.9%)	0.3%	Common (3.3%)	1.1%
Investigations (Findings based on test results presented as CTCAE grade shifts)
Leucocytes decreased	Very common (65%)	1.8%	Very common (88%)	20%
Lymphocytes decreased	Very common (64%)	8%	Very common (78%)	16%
Platelet count decreased	Very common (53%)	1.3%	Very common (85%)	16%
Neutrophils decreased	Very common (36%)	4.0%	Very common (85%)	36%
Blood creatinine increased	Common (9%)	0.2%	Very common (22%)	0.4%
Musculoskeletal and connective tissue disorders
Myositis	Uncommon (0.2%)	0%	0%	0%

Consult SmPC for further information and detail, including adverse events and management. Note: ILD, severe cutaneous adverse reactions, QTc interval prolongation, keratitis, and aplastic anaemia are special warnings for Tagrisso.
1. Tagrisso. Summary of Product Characteristics.

GB-64711 | March 2025