SAFETY

Most adverse reactions with TAGRISSO were mild to moderate across the FLAURA and AURA studies1

Adverse reactions reported* Overall frequency (all grades)
(%)
Grade ≥3
(%)

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease

Common (3.9)

1.5

Gastrointestinal disorders

Diarrhoea

Very common (49)

1.2

Stomatitis

Very common (20)

0.2

Eye disorders

Keratitis

Uncommon (0.7)

0.1

Skin and subcutaneous tissue disorders

Rash

Very common (47)

0.9

Dry skin

Very common (33)

0.1

Paronychia

Very common (31)

0.3

Pruritus

Very common (17)

0.1

Investigations

QTc interval prolongation§

Uncommon (0.9)

Findings based on test results presented as CTCAE grade shifts

Platelet count decreased

Very common (54)

1.6

Leukocytes decreased

Very common (68)

1.5

Lymphocytes decreased

Very common (67)

7.2

Neutrophils decreased

Very common (35)

4.1

In patients treated with TAGRISSO 80 mg once daily,
2.1% had a dose reduction and 4.3% discontinued treatment
due to adverse reactions1

In patients treated with TAGRISSO 80 mg once daily, 2.1% had a dose reduction and 4.3% discontinued treatment due to adverse reactions1

Safety considerations*

  • If ILD is diagnosed, TAGRISSO should be permanently discontinued and appropriate treatment initiated as necessary1
  • Periodic monitoring with electrocardiograms (ECGs) and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval. Treatment should be withheld in patients who develop a QTc interval >500 msec on at least 2 separate ECGs, and TAGRISSO should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia1
  • Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases ≥10% and a drop to <50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment. Based on the available clinical trial data, it is not possible to determine a causal relationship between effects on changes in cardiac contractility and TAGRISSO. In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered1
  • In patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye should be referred promptly to an ophthalmology specialist1
  • Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher. Close monitoring is recommended in these patients1
  • Based on its mechanism of action and preclinical data, TAGRISSO may cause foetal harm when administered to a pregnant woman. TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with TAGRISSO1

Reference:
1. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2018.