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
Nilotinib Tablets (Danziten™) Are Now Included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CML1
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.
1. 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 March 13, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.
NCCN = National Comprehensive Cancer Network.
Danziten™: The Only Nilotinib With No Fasting Requirements1
Danziten™ Is Dosed Twice Daily With No Fasting Requirements1
| Recommended Dosage and Administration1 | |
|---|---|
| Indication | Dosage and Administration |
| Adult Patients With Newly Diagnosed Ph+ CML-CP | 142 mg orally twice daily at ~12-hour intervals with or without food |
| Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP | 190 mg orally twice daily at ~12-hour intervals with or without food |
Danziten™ may not be substitutable with other nilotinib products on a milligram per milligram basis; to avoid medication errors, including overdosage or underdosage, when using Danziten™ ensure that the recommended dosage of Danziten™ (not the recommended dosage of other nilotinib products) is prescribed.1
Danziten™ may be given in combination with hematopoietic growth factors, such as erythropoietin or G-CSF if clinically indicated. Danziten™ may be given with hydroxyurea or anagrelide if clinically indicated.1
Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation's Tasigna® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information.1
Product labeling, packaging, and imagery are for representation purposes only and shall constitute the property of Azurity.
How Is Danziten™ Supplied?1
Danziten™ is available as 71 mg and 95 mg tablets.
Danziten™ is supplied in a blister pack that assists patients in monitoring their medication doses effectively.
Additional Dosing Information1
Danziten™ may be given in combination with hematopoietic growth factors, such as erythropoietin or replaced with Granulocyte colony-stimulating factor (G-CSF) if clinically indicated. Danziten™ may be given with hydroxyurea or anagrelide if clinically indicated.
Reduce starting dose of Danziten™ in patients with hepatic impairment.
Withhold or reduce Danziten™ dosage for hematological toxicities (neutropenia, thrombocytopenia) that are not related to underlying leukemia.
For non-hematologic laboratory abnormalities (Grade ≥3) such as elevated serum lipase, amylase, bilirubin, or hepatic transaminases, withhold Danziten™ and monitor levels, resume treatment at 190 mg once daily when serum levels return to Grade ≤1.
Advise patients to swallow the tablets whole with water and not to cut, crush, or chew the tablets.
Advise patients to take Danziten™ with or without food. Patients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during Danziten™ treatment.
If the patient missed a dose of Danziten™, the patient should take the next scheduled dose at its regular time. The patient should not take 2 doses at the same time.
Danziten™ Offers Bioequivalence at Lower Doses Than Tasigna® With No Fasting Requirements1
Recommendations for switching to Danziten™ from Tasigna® based on dosage equivalence
Dosage Equivalence and Administration Instructions1,2
Approved Indications
Danziten™ Dosage and Administration
Tasigna® Dosage and Administration
Newly diagnosed Ph+ CML-CP
142 mg orally twice daily with or without food
300 mg orally twice daily on an empty stomach
No food should be consumed for ≥2 hours before the dose is taken and for ≥1 hour after the dose is taken
Resistant or intolerant PH+ CML-CP and CML-AP
190 mg orally twice daily with or without food
400 mg orally twice daily on an empty stomach
No food should be consumed for ≥2 hours before the dose is taken and for ≥1 hour after the dose is taken
This chart is offered as a side-by-side comparison based on the product labels. Azurity does not confirm other products' labels. Reporting of any adverse effects, product quality complaints, or medical information request regarding CML-CP and CML-AP treatment options should be directed to their respective manufacturer.
Discontinuation of Treatment After a Sustained Molecular Response (MR4.5) on Danziten™1
Ph+ CML-CP patients with typical BCR-ABL transcripts, who have been taking Danziten™ for a minimum of 3 years and have achieved a sustained molecular response may be eligible for treatment discontinuation.
Criteria for discontinuation in patients with newly diagnosed Ph+ CML-CP11
Criteria for discontinuation in patients with Ph+ CML-CP that are resistant to or intolerant to imatinib1
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. Tasigna (prescribing information): East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024.