For Patients With Ph+ CML
Danziten® Offers the Proven Efficacy of Nilotinib1
Nilotinib is Backed by 17 Years of Experience Treating Patients With Newly Diagnosed Ph+ CML and Ph+ CML Resistant to or Intolerant to Imatinib1
The effectiveness of 142 mg twice daily of Danziten® (nilotinib) tablets for the treatment of adult patients with newly diagnosed Ph+ CML-CP has been established from an adequate and well-controlled study of Tasigna® (nilotinib) capsules, which has a different recommended dosage than Danziten®. Below are the results of Tasigna® (nilotinib) capsules in an adequate and well-controlled study.1
Nilotinib Significantly Reduces the Risk of Progression to AP/BP and May Help Patients Achieve2:
CCyR
CCyR is defined as BCR::ABL1 value of ≤1%, or 1 out of every 100 cells has the BCR::ABL1 gene
MMR
MMR is defined as BCR::ABL1=0.1%, or 1 out of every 1000 cells has the BCR::ABL1 gene
MR4.5
Deep molecular responses (eg, MR4.5) MR4.5=4.5-log reduction, indicating that 0.0032% of cells (1 out of every 32,000 cells) have the BCR::ABL1 gene3
Nilotinib Efficacy in Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP1
The effectiveness of 190 mg twice daily of Danziten® (nilotinib) tablets for the treatment of adult patients with Ph+ CML- CP and Ph+ CML-AP resistant or intolerant to prior therapy that included imatinib has been established from an adequate and well-controlled study of Tasigna® (nilotinib) capsules, which has a different recommended dosage than Danziten®. Below are the results of Tasigna® (nilotinib) capsules from this adequate and well-controlled study.
MMR in Adult Patients With Resistant or Intolerant CP Ph+ CML Treated With Nilotinib (n=321)
Efficacy of Nilotinib (Confirmed Hematologic Response Rate) in Adult Patients With Resistant or Intolerant AP Ph+ CML (n=137)
Treatment-free Remission (TFR) Is Possible With Nilotinib1
TFR is the ability for eligible patients who achieved a sustained MR4.5 to maintain MMR in the frontline after discontinuing nilotinib.
The efficacy of Danziten® (nilotinib) tablets treatment discontinuation in adult patients with newly diagnosed Ph+ CML-CP has been established from an adequate and well-controlled study of Tasigna® (nilotinib) capsules, which has a different recommended dosage than Danziten®. Below is a display of the results of Tasigna® capsules from this adequate and well-controlled study.
The ENESTfreedom (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-freedom) study looked at treatment discontinuation in newly diagnosed Ph+ CML-CP patients who achieved a sustained molecular response (MR4.5). Two hundred fifteen adult patients with Ph+ CML-CP treated with nilotinib as first-line treatment for ≥2 years who achieved MR4.5 and were enrolled to continue nilotinib treatment for an additional 52 weeks (nilotinib consolidation phase); 88.4% of patients (190/215) entered the TFR phase after achieving MR4.5 during the consolidation phase.
~50% (n=93/190) of patients remained in TFR 2 years after discontinuing nilotinib treatment.
EMR May Help Patients Start on the Path to TFR Sooner2
An assessment of 4-year follow-up data from the ENESTnd trial found that 91% of patients on nilotinib 300 mg twice daily and 89% of patients on nilotinib 400 mg twice daily achieved EMR at 3 months.
Of the patients who achieved EMR at 3 months:
80% (167/209) on nilotinib 300 mg twice daily and 75% (163/218) on nilotinib 400 mg twice daily achieved MMR by 2 years
47% (109/233) on nilotinib 300 mg twice daily and 42% (98/231) on nilotinib 400 mg twice daily achieved MR 4.5 by 4 years
EMR
3 Months
MMR
2 Years
MR4.5
4 Years
TFR
Nilotinib Is the Only TKI With In-label Eligibility Criteria to Enter TFR for Patients With Ph+ CML1
Discontinuation of nilotinib can be considered in patients with newly diagnosed Ph+ CML-CP who have
Been treated with Danziten® for at least 3 years
Maintained a molecular response of at least MR 4.0 (corresponding to = BCR-ABL/ABL ≤0.01% IS) for 1 year prior to discontinuation of therapy
Achieved an MR4.5 for the last assessment taken immediately prior to discontinuation of therapy
Been confirmed to express the typical BCR-ABL transcripts (e13a2/b2a2 or e14a2/b3a2)
No history of accelerated phase or blast crisis
No history of prior attempts of TFR discontinuation that resulted in relapse
Danziten® Offers Nilotinib's Well-established Safety Profile 1
The safety of Danziten® (nilotinib) tablets has been established from adequate and well-controlled studies of Tasigna® (nilotinib) capsules, which has different recommended dosages than Danziten®, in adult patients with newly diagnosed Ph+ CP-CML and adult patients with CP and AP Ph+ CML resistant to or intolerant to prior therapy that included imatinib. Below are the adverse reactions of Tasigna® (nilotinib) capsules in these adequate and well-controlled studies.
Most Common Adverse Reactions in Adult Patients With CML Treated With Nilotinib in Clinical Trials1
Most common non-hematologic adverse drug reactions
Most common hematologic adverse drug reactions (Grade 3/4)
Discontinuation due to adverse reactions
Adults With Newly Diagnosed Ph+ CP-CML
Most common (>10%) adverse reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, and upper abdominal pain
Constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain, peripheral edema, vomiting, and asthenia were observed less commonly (≤10% and >5%)
Myelosuppression, including: thrombocytopenia (10%), neutropenia (12%), and anemia (4%)
Observed in 10% of CP-CML patients
Adults With Resistant or Intolerant Ph+ CP-CML
Most common (≥10%) adverse reactions were rash, pruritus, nausea, fatigue, headache, constipation, diarrhea, vomiting, and myalgia
Common serious drug-related adverse reactions (≥1% and <10%) were thrombocytopenia, neutropenia, and anemia
Myelosuppression, including: thrombocytopenia (30%), neutropenia (31%), and anemia (11%)
Observed in 16% of CP-CML patients
Adults With Resistant or Intolerant Ph+ AP-CML
Most common (≥10%) adverse reactions were rash, pruritus and fatigue
Common serious adverse drug reactions (≥1% and <10%) were thrombocytopenia, neutropenia, febrile neutropenia, pneumonia, leukopenia, intracranial hemorrhage, elevated lipase, and pyrexia
Myelosuppression, including: thrombocytopenia (42%), neutropenia (42%), and anemia (27%)
Observed in 10% of AP-CML patients
Abbreviations: AP/BP=advanced phase/blast phase; BID=twice daily; CCyR=complete cytogenetic response; CML=chronic myeloid leukemia; CP=chronic phase; EMR=early molecular response; IS=international reporting scale; MMR=major molecular response; Ph+=Philadelphia chromosome- positive; QD=once daily.
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 [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc.; 2024. 2. 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. 3. Leukemia & Lymphoma Society. Chronic Myeloid Leukemia. Accessed November 6, 2024. https://www.lls.org/booklet/chronic-myeloid-leukemia