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Drug Interactions between betrixaban and midostaurin

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

midostaurin betrixaban

Applies to: midostaurin and betrixaban

MONITOR: Coadministration with inhibitors of P-glycoprotein (P-gp) may increase the plasma concentrations of betrixaban, which is a substrate of the efflux transporter. When administered with the potent P-gp inhibitor verapamil, betrixaban peak plasma concentration (Cmax) increased by nearly 5-fold and systemic exposure (AUC) increased by approximately 3-fold compared to betrixaban administered alone. When given with ketoconazole, another P-gp inhibitor, betrixaban Cmax and AUC increased by a little more than 2-fold each. In the Acute Medically Ill Prevention with Extended Duration Betrixaban (APEX) Study, use of betrixaban at a 50% dosage reduction in combination with P-gp inhibitors or in the presence of severe renal impairment was associated with increased relative risks of bleeding, including major bleeding, compared to treatment with enoxaparin.

MANAGEMENT: Caution is advised when betrixaban is used with P-gp inhibitors. Closer monitoring of the pharmacologic effects of betrixaban may be appropriate whenever a P-gp inhibitor is added to or withdrawn from therapy. Patients should be routinely evaluated for signs and symptoms suggesting blood loss such as a drop in hemoglobin and/or hematocrit, hypotension, or fetal distress (in pregnant women). Concomitant use of betrixaban with P-gp inhibitors should be avoided in patients with severe renal impairment (CrCl<30 mL/min).

References

  1. "Product Information. Bevyxxa (betrixaban)." Portola Pharmaceuticals (2017):

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Drug and food interactions

Major

midostaurin food

Applies to: midostaurin

GENERALLY AVOID: Grapefruit juice may significantly increase the plasma concentrations of midostaurin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Ketoconazole, a potent CYP450 3A4 inhibitor, has been shown to increase midostaurin systemic exposure (AUC) by greater than 10-fold in healthy volunteers. Increased exposure to midostaurin may increase the risk of adverse effects such as nausea, vomiting, diarrhea, edema, hyperglycemia, hyperuricemia, QT prolongation, neutropenia, lymphopenia, thrombocytopenia, and anemia.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of midostaurin. Relative to fasting conditions, midostaurin systemic exposure (AUC) increased by approximately 1.2-fold when administered with a standard meal (457 calories; 50 g fat, 21 g proteins, 18 g carbohydrates) and 1.6-fold when administered with a high-fat meal (1007 calories; 66 g fat, 32 g proteins, 64 g carbohydrates), while midostaurin peak plasma concentration (Cmax ) decreased by 20% and 27%, respectively.

MANAGEMENT: The manufacturer recommends taking midostaurin with food. Midostaurin was administered with food in clinical trials. Patients should avoid consumption of grapefruit and grapefruit juice during treatment with midostaurin.

References

  1. "Product Information. Rydapt (midostaurin)." Novartis Pharmaceuticals (2017):

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Moderate

betrixaban food

Applies to: betrixaban

ADJUST DOSING INTERVAL: Food reduces the oral bioavailability of betrixaban. When administered with a low-fat (900 calories; 20% fat) or high-fat (900 calories; 60% fat) meal, betrixaban peak plasma concentration (Cmax) and systemic exposure (AUC) decreased relative to administration in the fasting state by an average of 70% and 61%, respectively, with the low-fat meal and 50% and 48%, respectively, with the high-fat meal. The effect of food on betrixaban pharmacokinetics could be observed for up to 6 hours after meal intake.

MANAGEMENT: The manufacturer recommends taking betrixaban at the same time each day with food.

References

  1. "Product Information. Bevyxxa (betrixaban)." Portola Pharmaceuticals (2017):

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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