1. Medicines
  2. Haematology
  3. TASIGNA® (nilotinib)
  4. Safety and tolerability with Tasigna

Prescribing information

 

Safety and tolerability with Tasigna® (nilotinib)

   

Staying the course with confidence

Tasigna has a well-established, manageable tolerability profile.1–4

Results from the 10-year ENESTnd study demonstrate the consistent tolerability profile of Tasigna.4

Non-haematologic AEs in Tasigna trials*1,2

Adverse events Newly diagnosed† Imatinib▼-resistant or -intolerant‡
Tasigna

300 mg BID (%), N=279		 Tasigna

400 mg BID (%), N=458
Decreased appetite 4 8
Headache 16 15
Nausea 14 20
Constipation 10 12
Diarrhoea 9 11
Vomiting 6 10
Abdominal pain (upper) 10 5
Abdominal pain 6 6
Dyspepsia 5 3
Rash 33 28
Pruritus 18 24
Alopecia 10 9
Dry skin 10 5
Erythema 3 5
Myalgia 10 10
Arthralgia 8 7
Muscle spasms 9 8
Bone pain 4 6
Pain in extremity 5 5
Fatigue 12 17
Asthenia 9 6
Oedema peripheral 5 6

Grade 3/4 haematologic abnormalities in Tasigna trials*1,2

Adverse events Newly diagnosed† Imatinib-resistant or -intolerant‡
Tasigna

300 mg BID (%), N=279		 Tasigna

400 mg BID (%), N=321
Neutropenia 12 31
Thrombocytopenia 10 30
Anaemia 4 11

Grade 3/4 biochemical abnormalities (≥5%) in Tasigna trials§1,2

Adverse events Newly diagnosed Imatinib-resistant or -intolerant CML-CP
Tasigna

300 mg BID (%), N=279		 Tasigna

400 mg BID (%), N=321
Elevated lipase 9 18
Decreased phosphate 8 17
Elevated glucose 7 12
Elevated ALT 4 4
Elevated bilirubin 4 7
Elevated cholesterol (total) 0 Parameter not collected
Elevated triglycerides 0 Parameter not collected

CV risk is associated with all TKIs1,2,5–9

2016 ELN recommendations for the management of adverse events during the treatment of CML outline that the cardiovascular risk associated with all TKIs is managed with regular monitoring and follow-up.5

  • CVEs have been reported with all approved TKIs; incidence variations across TKI clinical trials may be due to differences in reporting protocols6–8
  • CVE rates were similar across second generation TKIs in an independent retrospective analysis at MD Anderson using a consistent, broad range of CVE definitions¶9

There is NO contraindication for Tasigna in patients with manageable CV risk factors.1,2

 

Chart showing frequencies of cardiovascular and arteriothrombotic events with 4 different tyrosine kinase inhibitors.

 

The cardiovascular status of patients should be evaluated and cardiovascular risk factors monitored and actively managed during nilotinib therapy according to standard guidelines. Appropriate therapy should be prescribed to manage cardiovascular risk factors.1,2

 

Optimal AE management ensures patients receive antileukaemic effect of CML therapy, per ELN5

 

* Safety from an open-label multicentre Phase II study in adult patients with imatinib-resistant or -intolerant CML in chronic phase (n=321) and accelerated phase (n=137) treated at the recommended dose of 400 mg BID.1,2

† Based on 60-month analysis.1,2

‡ Based on 24-month analysis.1,2

§ Safety results from a Phase III study in patients with newly diagnosed Ph+ CML-CP treated at the recommended dose of 300 mg BID (n=279) and from an open-label multicentre Phase II study in adult patients with imatinib-resistant or -intolerant CML-CP (n=321) treated at the recommended dose of 400 mg BID.1,2

Bosutinib was not included in this analysis.9

AE, adverse event; ALT, alanine transaminase; BID, twice daily; CML, chronic myeloid leukaemia; CP, chronic phase; CV, cardiovascular; CVE, cardiovascular event; ELN, European LeukemiaNet; ENEST, Evaluating Nilotinib Efficacy and Safety in Clinical Trials; Ph+, Philadelphia chromosome positive; TKI, tyrosine kinase inhibitor.

References

  1. Tasigna® (nilotinib 200 mg and 50 mg) Summary of Product Characteristics. 2022.
  2. Tasigna® (nilotinib 150 mg) Summary of Product Characteristics. 2022.
  3. Larson RA, et al. Blood. 2014;124(21):4541.
  4. Hughes TP, et al. Presented at ASH 2019; 7–10 December, Orlando, USA. Poster 2924.
  5. Steegmann JL, et al. Leukemia. 2016;30(8):1648–1671.
  6. Hochhaus A, et al. N Engl J Med. 2017;376(10):917–927.
  7. Cortes JE, et al. J Clin Oncol. 2016;34(20):2333–2340.
  8. Cortes JE, et al. J Clin Oncol. 2018;36(suppl 15):7002.
  9. Jain P, et al. Blood Adv. 2019;3(6):851–861.
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UK | May 2022 | 205632
Haematology
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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