Important Announcement About
DANZITEN Formulary Coverage as of February 14, 2025
DANZITENTM is PREFERRED
on Express Scripts (ESI)
2025 National Preferred Formulary
*Data on file. Azurity Pharmaceuticals, Inc. 2025.
PP-DAN-US-0129
Finally, a Nilotinib With 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.
Danziten™ gives your patients the proven efficacy expected from nilotinib, the only TKI with in-label eligibility criteria to enter treatment-free remission1-3
Nilotinib Efficacy
Danziten™ offers consistent PK with or without food and has improved bioavailability over Tasigna® allowing for a lower dose1,4,5
PK StudiesAbbreviations: CML=chronic myeloid leukemia; PK=pharmacokinetics; TKI=tyrosine kinase inhibitor.
aPatients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during Danziten™ treatment.
Your trusted guide on your patient's CML treatment journey.
From the first step to ongoing support, we're with you every day and every way possible.
Your patients may get their first month freea and commercially insured eligible patients may pay as little as $0 per prescriptiona
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
References: 1. DANZITEN [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc.; 2024. 2. 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. 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. 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. 5. Data on file. Azurity Pharmaceuticals. 2024.