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LABELS · 62029a35-74af-47bc-9b7b-93dcaddfd278

DANZITEN

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-07-28
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ see Warnings and Precautions ( 5.4 ) ]. Do not administer DANZITEN tablets to patients with hypokalemia, hypomagnesemia, or long QT syndrome [ see Contraindications (4), Warnings and Precautions ( 5.3 ) ]. • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [ see Drug Interactions ( 7.1 , 7.2 ) ]. WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. ( 5.3 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.3 , 5.4 , 5.8 , 5.12 ) • Sudden deaths have been reported in patients receiving nilotinib. ( 5.4 ) Do not administer DANZITEN to patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 , 5.3 ) • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP DANZITEN is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Full extracted label fields
application numbers
  1. NDA219293
boxed warning exact
  1. WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ see Warnings and Precautions ( 5.4 ) ]. Do not administer DANZITEN tablets to patients with hypokalemia, hypomagnesemia, or long QT syndrome [ see Contraindications (4), Warnings and Precautions ( 5.3 ) ]. • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [ see Drug Interactions ( 7.1 , 7.2 ) ]. WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. ( 5.3 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.3 , 5.4 , 5.8 , 5.12 ) • Sudden deaths have been reported in patients receiving nilotinib. ( 5.4 ) Do not administer DANZITEN to patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 , 5.3 ) • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2 )
brand names
  1. DANZITEN
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d288d165-3505-49bb-9b2e-124490d65f49
generic names
  1. NILOTINIB
id
62029a35-74af-47bc-9b7b-93dcaddfd278
indications and usage exact
  1. 1 INDICATIONS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP DANZITEN is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna ® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Azurity Pharmaceuticals, Inc.
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    1. leukemia
    package ndcs
    1. 24338-154-03
    2. 24338-154-02
    3. 24338-154-01
    4. 24338-155-03
    5. 24338-155-02
    6. 24338-155-01
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    1. 24338-154
    2. 24338-155
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    1. HUMAN PRESCRIPTION DRUG
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      1. application number
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        payload
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        approval interpretation
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        openfda application present
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        products
        1. Active Ingredient
          NILOTINIB TARTRATE
          Appl No
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          Drug Name
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          Product No
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          Reference Drug
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          Reference Standard
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          marketing status
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          Drug Name
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          Product No
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          Reference Drug
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          Reference Standard
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      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
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      1 INDICATIONS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP)
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            1 INDICATIONS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of:
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            1 INDICATIONS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) 1.1 Adult Patients with Newly Diagnosed
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                NS AND USAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) 1.1 Adult Patients with Newly Diagnosed Ph+ CML
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                      SAGE DANZITEN is a kinase inhibitor indicated for the treatment of: • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 ) 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph
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                                                        Preserved source evidence · Not medical advice