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For the First Time, A Nilotinib Without Fasting Restrictions

When people are diagnosed with Philadelphia chromosome chronic myeloid leukemia (Ph + CML), the majority are faced with the challenge of living with a chronic illness and the prospect of long-term treatment.i ii That’s why it is important for medicines to not only be effective and safe, but to be able to be integrated into a patient’s life with minimal disruption.ii

For more than 17 years, nilotinib has been looked to as a trusted medication for treating patients with Ph+CML because of its proven efficacy, potential for treatment-free remission, and established safety profile.ii iii However, until last November, the only nilotinib available was Tasigna® (nilotinib) capsules, which comes with strict fasting requirements. Tasigna must be taken on an empty stomach, and no food should be consumed for 2 hours before the dose is taken and one hour after. With the twice-daily recommended dosing of Tasigna, this results in a total of 6 hours of fasting per day.iv

These restrictions can be challenging for people who are living busy lives, forcing them to structure their days around their medication schedule, avoiding food for long stretches to adhere to their treatment regimen. Studies have shown that some patients skip fasting due to time constraints, risking adverse drug-food interaction. Medication adherence may be impacted by the fasting requirements of Tasigna.v

Danziten™ (nilotinib) tablets were approved by the FDA on November 7, 2024, offering providers and patients an improved formulation of nilotinib. Danziten is indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and accelerated phase (AP) resistant or intolerant to prior therapy that included imatinib. This drug represents the first and only nilotinib formulation that can be taken without mealtime restrictions. This marks the only nilotinib that eliminates the need for fasting, while offering the expected proven efficacy of nilotinib.vi Removing fasting requirements may make it easier for patients to continue treatment with more flexibility throughout their day.v

Nilotinib is associated with concentration-dependent QT prolongation. Tasigna, in a concentration dependent manner, may significantly prolong QT interval on surface electrocardiogram when inappropriately taken with food. Studies have shown that food can affect the bioavailability of Tasigna, with as much as an 82% increase in systemic exposure of nilotinib if Tasigna is taken within 30 minutes of a high fat meal.iv Danziten showed no signs of QT prolongation in healthy subject studies regardless of fasting state or meal type.vi No new significant QT findings were observed in healthy subject studies with single doses of Danziten given with or without food, and no QT prolongation events were noted in any of the 14 pharmacokinetics (PK) studies associated with Danziten. However, Danziten still has risk of QT prolongation as stated in the boxed warning.vi

Danziten (nilotinib) tablets are a unique, re-engineered formulation of nilotinib that incorporates a different salt form.iv vi Danziten is an amorphous solid dispersion that helps increase bioavailability and controls the release of nilotinib, which helps it get absorbed in the GI tract and not in the stomach, which likely minimizes drug-food interaction.vi This allows Danziten to be bioequivalent to Tasigna but at a lower dose with improved bioavailability.vi vii Danziten and Tasigna are different formulations and dosage forms of nilotinib. Danziten may not be substitutable with other nilotinib products on a milligram per milligram basis.vi

While nilotinib has been a trusted choice for treating Ph + CML for almost two decades, the introduction of Danziten as the first and only nilotinib with no fasting requirements, it may help overcome the challenges fasting restrictions may pose to patients on a daily basis, and also may address adherence issues.vi viii

Nilotinib tablets (Danziten™) are now included in the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CML. NCCN® recognizes nilotinib tablets (Danziten™) have improved bioavailability over nilotinib capsules (without compromise in efficacy) that allows for administration at a lower dose without mealtime restrictions. Nilotinib products are available in different formulations, dosage forms, and strengths that are subject to different administration instructions.ix

NCCN = National Comprehensive Cancer Network

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

For more information visit www.Danziten.com.

Sponsored by Azurity Pharmaceuticals, Inc.

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 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.

Fluid Retention: Monitor patients for unexpected rapid weight gain, swelling, and shortness of breath. Manage medically.

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.

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i Treating Chronic Myeloid Leukemia. American Cancer Society. Accessed February 12, 2025. https://www.cancer.org/content/dam/CRC/PDF/Public/8687.00.pdf

ii Chronic Myeloid Leukemia. Leukemia & Lymphoma Society; 2023. Accessed February 12, 2025. https://www.lls.org/sites/default/files/2023-06/PS31_CML_2023.pdf

iii Hochhaus A, Masszi T , Giles FJ, et al. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study. Leukemia. 2017;31(7):1525-1531. 

iv Tasigna [prescribing information]: East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024.

v Tan BK, Tan SB, Chen L. Medication-related issues associated with adherence to long-term tyrosine kinase inhibitors for controlling chronic myeloid leukemia: a qualitative study. Patient Prefer Adherence. 2017;11:1027-1034. 

vi DANZITEN [prescribing information]: Woburn, MA: Azurity Pharmaceuticals, Inc; 2024.

vii Radich J, Mauro M, Jain P, et al. Population pharmacokinetic (PopPK) modeling for a novel nilotinib formulation. Presented at: SOHO 2024 Annual World; September 4-7, 2024; Houston, TX.

viii Boons CCLM, Timmers L, Janssen JJWM, et al. Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib. Eur J ClinPharmacol. 2020;76(9):1213-1226.

ix Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V.3.2025. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed April 13, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

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