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Gilteritinib Fumarate and Zithromax Tri-Pak

Determining the interaction of Gilteritinib Fumarate and Zithromax Tri-Pak and the possibility of their joint administration.

Check result:
Gilteritinib Fumarate <> Zithromax Tri-Pak
Relevance: 08.05.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Consumer information for this interaction is not currently available.MONITOR: Gilteritinib may cause dose-related prolongation of the QT interval. Theoretically, coadministration with other agents that can prolong the QT interval may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. The effect of gilteritinib 120 mg once a day on the QTc interval has been evaluated in clinical study patients, which showed an absence of large mean increases (i.e., 20 msec). Of 317 patients with a post-baseline QTc measurement during treatment with gilteritinib 120 mg/day in clinical trials, 4 patients (1.3%) experienced a QTcF >500 msec. Across all doses, 2.3% of patients with relapse/refractory acute myeloid leukemia had a maximum post-baseline QTcF interval >500 msec. Additionally, 7% of patients had an increase in QTc from baseline greater than 60 msec. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s). MANAGEMENT: Caution and clinical monitoring are recommended if gilteritinib is used in combination with other drugs that can prolong the QT interval. Patients should have electrocardiograms (ECGs) performed prior to initiation of treatment with gilteritinib, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. If QTc interval is greater than 500 msec at any time during treatment or greater than 30 msec of baseline on day 8 of cycle 1, interrupt and reduce gilteritinib dosing in accordance with product labeling recommendations. Because hypokalemia and hypomagnesemia are risk factors for ventricular arrhythmias, electrolyte levels should also be obtained prior to and during treatment, and any abnormalities corrected as necessary. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope. References "Product Information. Xospata (gilteritinib)." Astellas Pharma US, Inc, Deerfield, IL.

Professional:

MONITOR: Gilteritinib may cause dose-related prolongation of the QT interval. Theoretically, coadministration with other agents that can prolong the QT interval may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. The effect of gilteritinib 120 mg once a day on the QTc interval has been evaluated in clinical study patients, which showed an absence of large mean increases (i.e., 20 msec). Of 317 patients with a post-baseline QTc measurement during treatment with gilteritinib 120 mg/day in clinical trials, 4 patients (1.3%) experienced a QTcF >500 msec. Across all doses, 2.3% of patients with relapse/refractory acute myeloid leukemia had a maximum post-baseline QTcF interval >500 msec. Additionally, 7% of patients had an increase in QTc from baseline greater than 60 msec. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).

MANAGEMENT: Caution and clinical monitoring are recommended if gilteritinib is used in combination with other drugs that can prolong the QT interval. Patients should have electrocardiograms (ECGs) performed prior to initiation of treatment with gilteritinib, on days 8 and 15 of cycle 1, and prior to the start of the next two subsequent cycles. If QTc interval is greater than 500 msec at any time during treatment or greater than 30 msec of baseline on day 8 of cycle 1, interrupt and reduce gilteritinib dosing in accordance with product labeling recommendations. Because hypokalemia and hypomagnesemia are risk factors for ventricular arrhythmias, electrolyte levels should also be obtained prior to and during treatment, and any abnormalities corrected as necessary. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.

References
  • "Product Information. Xospata (gilteritinib)." Astellas Pharma US, Inc, Deerfield, IL.
Gilteritinib Fumarate

Generic Name: gilteritinib

Brand name: Xospata

Synonyms: Gilteritinib

Zithromax Tri-Pak

Generic Name: azithromycin

Brand name: Zithromax, Zmax, AzaSite, Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax Tri-Pak, Zithromax Z-Pak, Zithromax IV

Synonyms: Zithromax

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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