Label Changes for:

Tasigna (nilotinib) capsules

August 2009

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

BOXED WARNING

  • A dose reduction is recommended in patients with hepatic impairment.

WARNINGS AND PRECAUTIONS

Hepatic Impairment
  • Nilotinib exposure is increased in patients with impaired hepatic function. A dose reduction is recommended for patients with mild to severe hepatic impairment and QT interval should be monitored closely.

DRUG INTERACTIONS

Effects of Nilotinib on Drug Metabolizing Enzymes and Drug Transport Systems
  • In vitro studies also suggest that nilotinib may induce CYP2B6, CYP2C8 and CYP2C9, and decrease the concentrations of drugs which are eliminated by these enzymes.
  • Single-dose administration of Tasigna to healthy subjects did not change the pharmacokinetics and pharmacodynamics of warfarin. The ability of Tasigna to induce metabolism has not been determined in vivo

Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes

  • The administration of Tasigna with agents that are strong CYP3A4 inhibitors should be avoided. Concomitant use of Tasigna with medicinal products and herbal preparations that are potent inducers of CYP3A4 is likely to reduce exposure to nilotinib to a clinically relevant extent. Therefore, in patients receiving Tasigna, concomitant use of alternative therapeutic agents with less potential for CYP3A4 induction should be selected
Drugs that May Prolong the QT Interval
  • The administration of Tasigna with agents that may prolong the QT interval such as anti-arrhythmic medicines should be avoided.

MEDICATION GUIDE

Who should not take Tasigna?

  • Do not take if you have: low levels of potassium or magnesium in your blood or long QTc syndrome
During treatment with Tasigna, The tests will check (section updated)
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