HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TASIGNA safely and effectively. See full prescribing information for TASIGNA.
TASIGNA® (nilotinib) Capsules for oral use
Initial U.S. Approval: 2007
WARNING: QT PROLONGATION AND SUDDEN DEATHS
See full prescribing information for complete boxed warning.
-
Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5.7, 5.15).
-
Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2).
-
Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5.8).
-
Avoid food 2 hours before and 1 hour after taking the dose (5.9).
RECENT MAJOR CHANGES
Warnings and Precautions (5) 1/2015
INDICATIONS AND USAGE
Tasigna is a kinase inhibitor indicated for:
The treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
The treatment of chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib. (1.2)
DOSAGE AND ADMINISTRATION
-
Recommended Dose: Newly diagnosed Ph+ CML-CP: 300 mg orally twice-daily. Resistant or intolerant Ph+ CML-CP and CML-AP: 400 mg orally twice-daily. (2.1)
-
Take each Tasigna dose approximately 12 hours apart. Tasigna must be taken on an empty stomach. Avoid food for at least 2 hours before the dose is taken and avoid food for at least 1 hour after the dose is taken. (2.1)
-
Swallow the capsules whole with water. (2.1)
-
Dose adjustment may be required for hematologic and non-hematologic toxicities, and drug interactions. (2.2)
-
A lower starting dose is recommended in patients with hepatic impairment (at baseline). (2.2)
DOSAGE FORMS AND STRENGTHS
150 mg and 200 mg hard capsules (3)
CONTRAINDICATIONS
Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome. (4)
WARNINGS AND PRECAUTIONS
-
Myelosuppression: Associated with neutropenia, thrombocytopenia and anemia. CBC should be done every 2 weeks for the first 2 months, then monthly. Reversible by withholding dose. Dose reduction may be required. (5.1)
-
QT Prolongation: Tasigna prolongs the QT interval. Correct hypokalemia or hypomagnesemia prior to administration and monitor periodically. (5.2) Avoid drugs known to prolong the QT interval and strong CYP3A4 inhibitors. (5.8) Use with caution in patients with hepatic impairment (5.10). Obtain ECGs at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments. (5.2, 5.3, 5.7, 5.14)
-
Sudden deaths: Sudden deaths have been reported in patients with resistant or intolerant Ph+ CML receiving Tasigna. Ventricular repolarization abnormalities may have contributed to their occurrence. (5.3)
-
Cardiac and Arterial Vascular Occlusive Events: Cardiovascular events including ischemic heart disease, peripheral arterial occlusive disease and ischemic cerebrovascular events have been reported in patients with newly diagnosed Ph+ CML receiving Tasigna. Cardiovascular status should be eva luated and cardiovascular risk factors monitored and managed during Tasigna therapy. (
| 以下是“全球医药”详细资料 |
|
|
|
