Ph+ CML and Treatment Adherence: Rethinking Nilotinib Formulations and Fasting Restrictions

• For newly-diagnosed adult patients, the Danziten tablet dosage is 142 milligrams twice daily rather than the 300 milligram twice daily dose for Tasigna capsules.¹
• And for adult patients with resistant disease or intolerance, the dose is 190 milligrams of Danziten twice daily in place of 400 milligrams of Tasigna twice daily.¹  

So we need to be clear on prescriptions by explicitly stating Danziten tablets and specifying the lower-dose tablets to prevent medication errors.¹

Dr. Caudle:
You know with those practical considerations in mind, how can clinicians use shared decision-making to better understand any challenges patients may be having with adherence?

Dr. Mauro:
Shared decision-making is especially important when we’re considering factors that go beyond clinical data and look at treatment in the real world. One useful starting point is to check in with patients who are on medications with strict fasting requirements. Have you talked with them about the importance of fasting restrictions—and what might happen if they don’t follow those instructions consistently? Have you asked them if they've missed doses because of the fasting restrictions?

From there, you can open the conversation by asking how have fasting restrictions affected their day-to-day life. You might say, “Have you found it challenging to stick to the fasting requirements?”, “Have mealtime restrictions disrupted your routine in any way?”

Some patients may have found workarounds by altering sleep schedules or shifting mealtimes,^6,7 so you could follow up by asking, “Have you developed any strategies to manage these fasting requirement that have—or haven’t—worked well?” For patients who find fasting requirements difficult to manage, these discussions are a chance to explore alternatives like Danziten, which may support adherence and fit more easily with their lifestyle.

Dr. Caudle:
Thank you for that. And before we close, Dr. Mauro, what would you like our audience to take away from our discussion today?

Dr. Mauro:
Well, with the FDA approval of Danziten, we can offer adult patients with Philadelphia-positive CML a treatment option with comparable efficacy to Tasigna, including the opportunity for treatment-free remission, but without the fasting restrictions that may disrupt daily life.¹

Nilotinib tablets or (Danziten^TM) are now included in the NCCN Guidelines for CML,¹² so for newly diagnosed adult patients, Danziten should be part of the treatment discussion.  If fasting requirements are impacting adherence for adult patients currently on Tasigna, considering Danziten as a treatment option may be appropriate.⁶

The key is that we approach treatment selection through shared decision-making. This includes educating patients on Danziten’s efficacy and bioequivalence, and how removing fasting requirements with Danziten may work with their lifestyle.^1,6 And finally, let’s remember to clearly specify Danziten’s lower-dose tablets to prevent medication errors because Danziten is a different formulation and prescribed at a lower dose than nilotinib capsules.¹

Dr. Caudle:
Well that’s a great way to round out our discussion today. I’d like to thank my guest, Dr. Michael Mauro, for helping us better understand how Danziten is different from nilotinib capsules and can support adult patients with Philadelphia-positive CML. Dr. Mauro, it was great speaking with you today.

Dr. Mauro:
Thanks for having me.

Dr. Caudle:
Of course. For ReachMD, I’m your host Dr. Jennifer Caudle. Please stay tuned to hear Important Safety Information.

[Voiceover]
ADDITIONAL IMPORTANT SAFETY INFORMATION
Warnings and Precautions
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^TM is a trademark of Azurity Pharmaceuticals, Inc.

©2025 Azurity Pharmaceuticals, Inc.

Announcer:
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