Danziten®: Proven Efficacy of Nilotinib Without Compromising Life's Moments1
Danziten®: the first and only nilotinib with no mealtime restrictions1,a
Nilotinib tablets (Danziten®) are now included in the NCCN Guidelines for CML as a category 1, preferred treatment option2,b
aPatients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during Danziten® treatment.
bBased on high-level evidence (≥1 randomized phase 3 trial(s) or high-quality, robust meta-analysis), there is uniform NCCN consensus (≥85% support of the panel) that the intervention is appropriate.
Abbreviation: NCCN=National Comprehensive Cancer Network.
The proven efficacy expected from nilotinib, the only TKI with in-label eligibility criteria to enter treatment-free remission (TFR)1,3,4
Danziten® demonstrates no clinically significant PK differences in nilotinib exposure regardless of fasting state or meal type1
No fasting requirement with administration
The only nilotinib with no fasting requirements in the Boxed Warning
Available through Medically Integrated Dispensing Pharmacies (MIP), or through Biologics Specialty Pharmacy if MIP is not available
Danziten® supports MIPs as it is only available through in-practice pharmacies or Biologics Specialty Pharmacy by McKesson
A Medically Integrated Dispensing Pharmacy (MIP), as defined by Network for Collaborative Oncology Development & Advancement, is a pharmacy within an oncology center that uses a patient-centered, multidisciplinary approach. This improves outcomes through seamless coordination and comprehensive, on-site services5
For those that don't have MIP, Danziten® is available through Biologics Specialty Pharmacy by Mckesson
Access to Danziten® is supported by Azurity through Danziten CONNECT℠
Financial support includes first month free for eligible patients
Co-Pay program for eligible patients
Patient assistance program (PAP) for eligible patients
Danziten CONNECT℠ offers live access & reimbursement team member available to HCP/office staff
IMPORTANT SAFETY INFORMATION
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
References: 1. DANZITEN [prescribing information]. Woburn, MA: Azurity Pharmaceuticals, Inc.; 2024. 2. 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 November 27, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org 3. Hughes TP, Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014;123(9):1353-1360. 4. 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. 5. Medically Integrated Pharmacy: Enhancing Patient-Centered Oncology Care. Accessed May 21, 2025. https://www.ncoda.org/medically-integrated-pharmacy/