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 * Full Prescribing Information
 * Medication Guide
 * Important Safety Information
 * Azurity Pharmaceuticals
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 * Full Prescribing Information
 * Medication Guide
 * Important Safety Information
 * Azurity Pharmaceuticals
 * Sign Up For Email Updates

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 * Full Prescribing Information
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DANZITENTM: FINALLY, A NILOTINIB WITH NO MEALTIME RESTRICTIONS1,A

*Patients should not consume grapefruit products and other foods that are known
to inhibit CYP3A4 at any time during DanzitenTM treatment. TKI=tyrosine kinase
inhibitor.
Actor Portryals
Read Press Release

See Important Safety Information below.
Click for Full Prescribing Information, including Boxed Warning.


NOW FDA APPROVED

Available Soon for Your Patients


DANZITENTM IS A KINASE INHIBITOR INDICATED FOR THE TREATMENT OF1:

 * Adult patients with newly diagnosed Philadelphia chromosome-positive chronic
   myeloid leukemia (Ph+ CML) in chronic phase
 * Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML
   resistant to 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.


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See below important safety information.


IMPORTANT SAFETY INFORMATION


DANZITENTM (NILOTINIB) TABLETS, FOR ORAL USE

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.Adult patients with newly
   diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
   in chronic phase.
 * Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML
   resistant to or intolerant to prior therapy that included imatinib.


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)


ADDITIONAL IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

DANZITEN is contraindicated in patients with hypokalemia, hypomagnesemia, or
long QT syndrome.


WARNINGS AND PRECAUTIONS

SUBSTITUTION WITH OTHER NILOTINIB PRODUCTS AND RISK OF MEDICATION ERRORS:

DANZITEN tablets may not be substitutable with other nilotinib products,
including other nilotinib tablets, on a milligram per milligram basis. Confirm
that the intended nilotinib product is being prescribed and dispensed.



MYELOSUPPRESSION:

Monitor complete blood count (CBC) during therapy and manage by treatment
interruption or dose reduction.



CARDIAC AND ARTERIAL VASCULAR OCCLUSIVE EVENTS:

Evaluate cardiovascular status, monitor and manage cardiovascular risk factors
during DANZITEN therapy.



PANCREATITIS AND ELEVATED SERUM LIPASE:

Monitor serum lipase; if elevations are accompanied by abdominal symptoms,
interrupt doses and consider appropriate diagnostics to exclude pancreatitis.



HEPATOTOXICITY:

Monitor hepatic function tests monthly or as clinically indicated.



ELECTROLYTE ABNORMALITIES:

DANZITEN can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia,
and hyponatremia. Correct electrolyte abnormalities prior to initiating DANZITEN
and monitor periodically during therapy.



TUMOR LYSIS SYNDROME:

Maintain adequate hydration and correct uric acid levels prior to initiating
therapy with DANZITEN.



HEMORRHAGE:

Hemorrhage from any site may occur. Advise patients to report signs and symptoms
of bleeding and medically manage as needed.



EFFECTS ON GROWTH AND DEVELOPMENT IN PEDIATRIC PATIENTS:

Growth retardation has been reported in pediatric patients treated with
nilotinib. Monitor growth and development in pediatric patients.



EMBRYO-FETAL TOXICITY:

Can cause fetal harm. Advise females of reproductive potential of potential risk
to a fetus and to use effective contraception.



TREATMENT DISCONTINUATION:

Patients must have typical BCR-ABL transcripts. An FDA-authorized test with a
detection limit below MR4.5 must be used to determine eligibility for
discontinuation. Patients must be frequently monitored by the FDA authorized
test to detect possible loss of remission.




ADVERSE REACTIONS

The most commonly reported non-hematologic adverse reactions (≥20%) in adult
patients are nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea,
cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.
Hematologic adverse drug reactions include myelosuppression: thrombocytopenia,
neutropenia, and anemia.

These are not all the possible side effects of DANZITEN. Please see Full
Prescribing Information for a full list.


DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use, including grapefruit juice with
DANZITEN or reduce DANZITEN dose if concomitant use cannot be avoided.

Strong CYP3A Inducers: Avoid concomitant use with DANZITEN.

Proton Pump Inhibitors: Use short-acting antacids or H2 blockers as an
alternative to proton pump inhibitors.

See Full Prescribing Information for Specific Drugs and Interactions.


USE IN SPECIFIC POPULATIONS

LACTATION:

Advise women not to breastfeed.



PEDIATRIC USE:

The safety and effectiveness of nilotinib in pediatric patients below the age of
1 year with newly diagnosed, or who are resistant to or intolerant to Ph+ CML in
chronic phase and accelerated phase have not been established.



The Important Safety Information does not include all the information needed to
use DANZITEN safely and effectively. Please see accompanying Full Prescribing
Information for DANZITEN.



To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at
1-800- 461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

DANZITENTM is a trademark of Azurity Pharmaceuticals, Inc.

©2024 Azurity Pharmaceuticals, Inc.

PP-DAN-US-0074

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The information contained herein, including product information, is intended
only for healthcare professionals in the United States.

© 2024 Azurity Pharmaceuticals, Inc. All Rights Reserved. DanzitenTM is a
trademark of Azurity Pharmaceutials, Inc. All trademarks referred to are the
property of their respective owners. PP-DAN-US-0070

Tasigna® is a registered trademark of Novartis Pharmaceuticals Corporation.