TASIGNA

What it is

TASIGNA contains nilotinib hydrochloride monohydrate and is available as capsules in 150 mg or 200 mg strengths. TASIGNA should be taken twice daily, approximately 12 hours apart, and must not be taken with food.

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 must not be taken with food, with no food 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 Grade 3 or 4 thrombocytopenia, neutropenia and anaemia, occurring more frequently in patients with imatinib-resistant or intolerant CML and particularly in patients with CML in accelerated phase. Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter. Nilotinib has the potential to prolong the QT interval on the heart. 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 QT prolongation may occur when TASIGNA is inappropriately taken with food and/or strong CYP3A4 inhibitors and/or medicines with a known potential to prolong QT interval, therefore co-administration with food must be avoided and concomitant use with strong CYP3A4 inhibitors should be avoided. Uncommon cases (0.1 to 1%) of sudden death have been reported in patients with imatinib-resistant or intolerant CML in chronic and accelerated phase receiving TASIGNA with a past medical history of cardiac disease or significant cardiac risk factors. Cardiovascular events including peripheral arterial occlusive disease, ischemic heart disease and ischemic cerebrovascular events were reported in extended follow-up of a Phase III trial in newly diagnosed CML patients. Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving TASIGNA, with some cases resulting in acute hepatic failure or fulminant hepatitis leading to liver transplantation or death. Patients should be tested for hepatitis B infection before initiating treatment with nilotinib.

Contraindications

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

PBS listing

TASIGNA capsules 150 mg are listed on the PBS with streamlined authority required restriction at an ex-manufacturer price of A$2730.52, and capsules 200 mg are listed with streamlined authority required restriction at an ex-manufacturer price of A$3617.80.

Regulatory history

TASIGNA 200 mg capsules were first registered on the ARTG on 17 January 2008, with 150 mg capsules registered on 5 September 2011. The TGA approved an expanded indication on 26 August 2011, extending TASIGNA's registration to include treatment of adult patients with newly diagnosed Philadelphia chromosome positive CML in chronic phase. This approval included registration of the new 150 mg strength capsule to support the recommended dosage for the new indication.