NILOTINIB VIATRIS

What it is

Tasigna contains nilotinib hydrochloride monohydrate and is available as 150 mg or 200 mg capsules. Nilotinib inhibits BCR-ABL tyrosine kinase activity in the nanomolar range by binding to the ATP-binding site. It inhibited 32/33 imatinib-resistant mutant forms of BCR-ABL tyrosine kinase that were tested.

Approved indications

— Treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (CML) in chronic phase. — Treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukaemia (CML) resistant to or intolerant of prior therapy including imatinib.

Dosing overview

Tasigna should be taken twice daily approximately 12 hours apart, and must not be taken with food. No food should be consumed for at least 2 hours before and 1 hour after the dose is taken.

Key safety warnings

Treatment with Tasigna is often associated with National Cancer Institute Common Toxicity Criteria Grade 3 or 4 thrombocytopenia, neutropenia and anaemia, with occurrence being more frequent in patients with imatinib-resistant or intolerant CML and particularly in patients with CML-accelerated phase. Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter, or as clinically indicated. In vitro data suggest that nilotinib has the potential to prolong the cardiac ventricular repolarisation QT interval. At the recommended dose of 300 mg twice daily, no patient had an absolute QTcF of greater than 480 milliseconds and no events of Torsades de Pointes were observed. Clinically meaningful prolongation of the QT interval may occur when Tasigna is inappropriately taken with food and/or with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong QT interval. Co-administration with food must be avoided and concomitant use with strong CYP3A4 inhibitors and/or medicinal products with a known potential to prolong QT should be avoided. Uncommon cases (0.1 to 1%) of sudden death have been reported in patients with imatinib-resistant or intolerant CML patients in chronic and accelerated phase receiving Tasigna with a past medical history of cardiac disease or significant cardiac risk factors, with comorbidities and concomitant medications also frequently present. Cardiovascular events were reported in an extended follow-up randomised Phase III nilotinib trial in newly diagnosed CML patients, with Grade 3/4 cardiovascular events including peripheral arterial occlusive disease (1.4% and 1.1% at 300 mg and 400 mg twice daily respectively), ischemic heart disease (2.2% and 6.1% at 300 mg and 400 mg twice daily respectively) and ischemic cerebrovascular events (1.1% and 2.2% at 300 mg and 400 mg twice daily respectively). Reactivation of hepatitis B can occur in patients who are chronic carriers after receiving a BCR-ABL tyrosine kinase inhibitor such as nilotinib, with some cases resulting in acute hepatic failure or fulminant hepatitis leading to liver transplantation or a fatal outcome.

Contraindications

Tasigna is contraindicated in patients with a known hypersensitivity to nilotinib or to any of the excipients.

PBS listing

No PBS listing information is available in the provided source documents.

Regulatory history

Tasigna (nilotinib 150 mg capsule) was first listed on the Australian Register of Therapeutic Goods on 13 April 2026 under licence category RE, sponsored by Seed Pharma. In August 2017, the Pharmaceutical Benefits Scheme Advisory Committee did not recommend any changes to the authority level for nilotinib listings for first-line treatment of CML.