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Midostaurin and Prestalia

Determining the interaction of Midostaurin and Prestalia and the possibility of their joint administration.

Check result:
Midostaurin <> Prestalia
Relevance: 03.08.2022 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:

AmLODIPine may increase the blood levels of midostaurin in some patients. You may be more likely to experience side effects such as nausea; vomiting; diarrhea; swelling; high blood sugar; heart rhythm abnormalities; and impaired bone marrow function resulting in low numbers of different types of blood cells, which can increase the risk of anemia, bleeding problems, and infections. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. You should seek medical attention if you develop paleness, fatigue, dizziness, fainting, unusual bruising or bleeding, fever, chills, diarrhea, sore throat, muscle aches, shortness of breath, blood in phlegm, weight loss, red or inflamed skin, body sores, or pain and burning during urination. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

MONITOR: Coadministration with inhibitors of CYP450 3A4 may increase the plasma concentrations of midostaurin and its active metabolites, which are all substrates of the isoenzyme. The increase in midostaurin concentrations may be particularly pronounced when CYP450 3A4 inhibitors are administered during the first week of midostaurin administration. When a single 50 mg dose of midostaurin was administered to healthy volunteers on day 6 of treatment with the potent CYP450 3A4 inhibitor ketoconazole (400 mg daily for 10 days), midostaurin systemic exposure (AUC) increased by 10.4-fold compared to administration with placebo. The AUC of the two active metabolites, CGP62221 and CGP52421, increased by 3.5- and 1.2-fold, respectively. When multiple doses of midostaurin (100 mg twice daily on days 1 and 2; 50 mg twice daily on days 3 to 28) were coadministered with itraconazole (100 mg twice daily on days 22 to 28 for 13 doses), the plasma concentrations on day 28 (Cmin) of midostaurin, CGP62221 and CGP52421 increased by 2.1-, 1.2- and 1.3-fold, respectively, compared to the corresponding day 21 Cmin concentrations with midostaurin alone. It is not known to what extent midostaurin may interact with weak and moderate CYP450 3A4 inhibitors.

MANAGEMENT: Caution is advised when midostaurin is used with CYP450 3A4 inhibitors. Patients should be closely monitored for increased adverse reactions (e.g., nausea, vomiting, diarrhea, edema, hyperglycemia, hyperuricemia, QT prolongation, neutropenia, lymphopenia, thrombocytopenia, anemia), especially during the first week of consecutive midostaurin administration in patients with advanced systemic mastocytosis and during the first week of midostaurin administration in each cycle of chemotherapy in patients with acute myeloid leukemia.

References
  • Dutreix C, Munarini F, Lorenzo S, Roesel J, Wang Y "Investigation into CYP3A4-mediated drug-drug interactions on midostaurin in healthy volunteers." Cancer Chemother Pharmacol 72 (2013): 1223-34
  • "Product Information. Rydapt (midostaurin)." Novartis Pharmaceuticals, East Hanover, NJ.
Midostaurin

Generic Name: midostaurin

Brand name: Rydapt

Synonyms: n.a.

Prestalia

Generic Name: amlodipine / perindopril

Brand name: Prestalia

Synonyms: n.a.

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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