Danziten and Tasigna are not interchangeable although both contain nilotinib

Medication Safety

Institute for Safe Medication Practice, Plymouth Meeting, PA

In November 2024, Azurity announced the approval of Danziten (nilotinib), indicated for adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP) and adults with CP and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.

Danziten is available in blister packs containing 71 mg or 95 mg tablets, which must be swallowed whole (i.e., not split, crushed, chewed) and may be taken with or without food.

Tasigna (nilotinib), manufactured by Novartis, is approved for the same indications as Danziten but for both adult and pediatric patients 1 year and older. Tasigna is available in different strengths—bottles containing 50 mg capsules or blister packs containing 150 mg or 200 mg capsules—and a different formulation than Danziten.

Due to Tasigna’s increased bioavailability when taken with food, it has a boxed warning to avoid food 2 hours before and 1 hour after taking the medication, or it may significantly prolong the QT interval. However, according to Tasigna prescribing information, the capsules may be opened and dispersed in one teaspoon of applesauce.

Both products have a boxed warning for QT prolongation and sudden death with specific monitoring recommendations and the need to avoid additional QT prolonging agents or strong CYP3A4 inhibitors.

These products are not interchangeable and have very different dosing recommendations. Because of this, there is a risk of under- or overdose and patient harm if the wrong product is selected for the ordered dosing regimen. The risk of a selection error may be increased if practitioners order the drug only by the generic name. For example, if the prescribed nilotinib dose is 300 mg every 12 hours by mouth, there may be some who think they can use three of the Danziten 95 mg tablets, round the dosage strength, and get close enough to the prescribed 300 mg dose. This would result in an overdose of Danziten.

Safe practice recommendations

• Build clinical decision support with dose range checking and warnings (e.g., avoid food 2 hours before and 1 hour after administering Tasigna).
• In the EHR, create order sentences that automatically link to the appropriate dosing formulation.
• Store these products separately and use barcode scanning when receiving and dispensing.
• Educate staff and patients that these products are not interchangeable and to confirm it is the correct brand name prior to dispensing and administration.
• During patient education, reinforce the specific brand the patient is taking, whether it should be taken with or without regard to food, and the correct dosing instructions, especially if the patient is directed to take a reduced or alternate dose than what is included in the blister pack.

ISMP recommends that drug information vendors and EHR vendors clearly differentiate these products and ensure they are not interchangeable in electronic systems. Medical offices, clinics, and pharmacies should evaluate how these drugs appear in their electronic systems and, if possible, only allow them to be ordered by brand name, or by both generic and brand names. ■