Danziten® Has No Mealtime Restrictions1,a

aPatients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during Danziten® treatment.

Understanding the Limitations of Fasting Restrictions For Your Patients2

Tasigna® has fasting requirements. Tasigna® should be taken on an empty stomach; no food should be consumed for at least 2 hours before the dose is taken and 1 hour after the dose is taken.2

Why are there strict mealtime restrictions with Tasigna®?

Tasigna® has variable bioavailability, which significantly increases when taken with food.2

Tasigna® exhibits an 82% increase in systemic exposure of nilotinib when a dose is taken 30 minutes after a high-fat meal.2

Taking Tasigna® in conjunction with food increases nilotinib blood levels, thereby increasing the risk of QTc prolongation. Because of this, nilotinib must be taken on an empty stomach. Patients should not eat for 2 hours before and 1 hour after taking Tasigna®.2

Importance of Adherence

Adherence to oral TKI therapy is important for the achievement of optimal response and the prevention of disease progression; however, nonadherence has been shown to be problematic for patients with CML.3

Fasting requirements may impact medication adherence to Tasigna®4-6


Multiple observational studies suggest that medication adherence may be impacted by the fasting requirements of Tasigna®4-6

Study 1

27% of patients did not take Tasigna® under fasting conditions

27% of patients reported that they did not always correctly take nilotinib under fasting conditions (ie, <60 minutes before or <120 minutes after food intake).4

Study 2

Patients considered taking Tasigna® more difficult

The fasting requirement associated with taking nilotinib was considered by patients as being more "difficult." Additionally, significantly more patients on nilotinib reported missing their doses than imatinib users (P<0.05). Treatment restrictions are burdensome to patients, which ultimately may affect adherence.6

Study 3

Patients reported not taking their Tasigna® on an empty stomach

Patients reported not taking their nilotinib on an empty stomach because the time needed for fasting interfered with their busy schedule, thus putting them at risk of adverse drug-food interactions.5

IMPORTANT SAFETY INFORMATION

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DANZITEN® (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 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.

Danziten® is a trademark of Azurity Pharmaceuticals, Inc.

©2025 Azurity Pharmaceuticals, Inc.

PP-DAN-US-0074

Abbreviation: QTc=heart-rate corrected QT interval.


References: 1. DANZITEN [prescribing information], Woburn, MA: Azurity Pharmaceuticals, Inc.; 2024. 2. Tasigna (prescribing information): East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024. 3. Ibrahim AR, Eliasson L, Apperley JF, et al. Poor adherence is the main reason for loss of CCYR and imatinib failure for chronic myeloid leukemia patients on long-term therapy. Blood. 2011;117(14):3733-3736. 4. 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 Clin Pharmacol. 2020;76(9):1213-1226. 5. 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. 6. Hirji I, Gupta S, Goren A, et al. Chronic myeloid leukemia (CML): association of treatment satisfaction, negative medication experience and treatment restrictions with health outcomes, from the patient's perspective. Health Qual Life Outcomes. 2013;11:167.