LABELS · fe0fef5b-4f09-4f67-946f-67e84d10e102

Tasigna

Open original source → · Download preserved record

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: 2025-12-16
Captured: 2026-09-09T23:38:04.335995+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: QT PROLONGATION and SUDDEN DEATHS Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions (5.2)] . Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [see Warnings and Precautions (5.2, 5.3, 5.7, 5.12)] . Sudden deaths have been reported in patients receiving Tasigna [see Warnings and Precautions (5.3)] . Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Contraindications (4), Warnings and Precautions (5.2)] . Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [see Drug Interactions (7.1, 7.2)] . Avoid food 2 hours before and 1 hour after taking the dose [see Dosage and Administration (2.1)] . 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 , 5.12) Sudden deaths have been reported in patients receiving Tasigna. ( 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. ( 7.1 , 7.2) Avoid food 2 hours before and 1 hour after taking the dose. ( 2.1 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3 ) 1.1 Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Tasigna is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. 1.2 Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna 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. 1.3 Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.

Full extracted label fields

application numbers

NDA022068

boxed warning exact

WARNING: QT PROLONGATION and SUDDEN DEATHS Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions (5.2)] . Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [see Warnings and Precautions (5.2, 5.3, 5.7, 5.12)] . Sudden deaths have been reported in patients receiving Tasigna [see Warnings and Precautions (5.3)] . Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Contraindications (4), Warnings and Precautions (5.2)] . Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [see Drug Interactions (7.1, 7.2)] . Avoid food 2 hours before and 1 hour after taking the dose [see Dosage and Administration (2.1)] . 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 , 5.12) Sudden deaths have been reported in patients receiving Tasigna. ( 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. ( 7.1 , 7.2) Avoid food 2 hours before and 1 hour after taking the dose. ( 2.1 )

brand names

Tasigna

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6093952a-5248-45cb-ad17-33716a411146

generic names

NILOTINIB

fe0fef5b-4f09-4f67-946f-67e84d10e102

indications and usage exact

1 INDICATIONS AND USAGE Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3 ) 1.1 Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-CP Tasigna is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. 1.2 Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna 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. 1.3 Pediatric Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP Tasigna is indicated for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.

indications and usage tables exact

is original packager

true

manufacturer names

Novartis Pharmaceuticals Corporation

matched search terms

leukemia

package ndcs

0078-0526-87
0078-0526-51
0078-0592-87
0078-0592-51
0078-0951-66

product ndcs

0078-0526
0078-0592
0078-0951

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

ORAL

rxcuis

746606
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997653
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source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00800.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 800
total: 830

terms

https://open.fda.gov/terms/

sha256

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url

source url

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spl effective date

2025-12-16

spl effective time

20251216

spl set id

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spl version

substance names

NILOTINIB HYDROCHLORIDE MONOHYDRATE

uniis

5JHU0N1R6K

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled

Drugs@FDA application source records

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payload
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Submissions Public Notes
application number
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approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
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drugsfda url
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official application record
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Appl Type
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Sponsor Name
NOVARTIS
openfda application present
true
products
Active Ingredient
NILOTINIB HYDROCHLORIDE
Appl No
022068
Drug Name
TASIGNA
Form
CAPSULE;ORAL
Product No
001
Reference Drug
1
Reference Standard
1
Strength
EQ 200MG BASE
marketing status
Prescription
Active Ingredient
NILOTINIB HYDROCHLORIDE
Appl No
022068
Drug Name
TASIGNA
Form
CAPSULE;ORAL
Product No
002
Reference Drug
1
Reference Standard
0
Strength
EQ 150MG BASE
marketing status
Prescription
Active Ingredient
NILOTINIB HYDROCHLORIDE
Appl No
022068
Drug Name
TASIGNA
Form
CAPSULE;ORAL
Product No
003
Reference Drug
1
Reference Standard
0
Strength
EQ 50MG BASE
marketing status
Prescription

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

application numbers

NDA022068

brand names

Tasigna

classification reasons

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clinical review status

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exact text: 1 INDICATIONS AND USAGE Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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 ) Pediatric patients greater than or equal
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qualifier mentions

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signa is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of a
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regulatory links

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exact text: 1 INDICATIONS AND USAGE Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
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source url

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spl effective date

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spl version

structured fields status

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structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 2 · unclassified context

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exact text: ed for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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 ) Pediatric patients greater than or equal to 1 yea
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source url

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spl effective date

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structured indication

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approval pathway: Source null
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disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

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Passage 3 · positive indication candidate

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exact text: he treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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 ) Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. ( 1.3 ) 1.1 Adult and Pediatric
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source text sha256: d12b10d64771b2123e6c20a38712880c72be3f9fb0b2588103161ecab841f904
start: 1173

source url

https://api.fda.gov/drug/label.json?search=id%3A%22fe0fef5b-4f09-4f67-946f-67e84d10e102%22

spl effective date

2025-12-16

spl set id

6093952a-5248-45cb-ad17-33716a411146

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Preserved source evidence · Not medical advice