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Safety and tolerabilityINLYTA® has a well-characterised safety and tolerability profile1–5 

Over 10 years, clinicians’ experience of INLYTA® has demonstrated the safety and tolerability profile of INLYTA® observed in clinical trials.1–5 

  • Only 4% of patients discontinued treatment with INLYTA® due to AEs in a Phase III clinical trial with INLYTA® monotherapy2
Common treatment emergent all-causality AEs in the AXIS study2 
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The short half-life of INLYTA® ensures that it is cleared more quickly following dose interruptions/discontinuations:1,2 

AEs
 		 INLYTA® (n=359) Sorafenib (n=355)
All grades (%)  ≥ Grade 3 (%) All grades (%) ≥ Grade 3 (%)
Diarrhoea 55 11 53 7
Hypertension  40 16 29 11
Fatigue 39 11 32 5
Decreased appetite 34 5 29 4
Nausea 32 3 22 1
Dysphonia 31 0 14 0
Hand–foot syndrome 27  5 51  16
Weight decreased 25  2 21 1
Vomiting 24 3 17 1
Asthenia 21 5 14 3
Constipation 20 1 20 1
Rash 13 <1 32 4
Alopecia 4 0 32 0
Hypothyroidism 19 <1 8 0
Cough 15 1 17 1
Mucosal inflammation 15 1 12 1
Arthralgia 15 1 11 1
Stomatitis 15 1 12 <1
Data are n (%).Adapted from Rini BI, et al. 2011. 

For some patients, taking a short break (e.g. 1–2 days) before restarting INLYTA® may help AEs to resolve quickly.1,6

AE, adverse event.
ReferencesINLYTA® Summary of Product Characteristics.Rini BI, et al. Lancet 2011;378:1931–1939.Melichar B, et al. Efficacy and tolerability of axitinib in metastatic renal cell carcinoma (mRCC): comparison of Czech clinical registry and AXIS trial data. ECC. 25–29 September 2015. Vienna, Austria. Poster: 2615.Matias M, et al. Eur J Cancer 2017;79:185–192.Rossetti S, et al. Activity of second line axitinib in metastatic renal cell carcinoma (mRCC) patients treated with sunitinib: results from SAX Italian real world trial. ASCO. 2–6 June 2017. Chicago, USA. Abstract: e16054.Larkin J, et al. Am J Clin Oncol 2014;37:397–403.
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Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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