Rydapt Dosage & Drug Information

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Core Prescribing Info

Contents

Midostaurin

Indications/Uses

Adult patients w/ aggressive systemic mastocytosis (ASM), systemic mastocytosis w/ associated haematological neoplasm (SM-AHN) or mast cell leukaemia (MCL). In combination w/ standard daunorubicin & cytarabine induction & high-dose cytarabine consolidation chemotherapy, & for patients in complete response followed by Rydapt single agent maintenance therapy for adult patients w/ newly diagnosed AML who are FLT3 mutation +ve.

Dosage/Direction for Use

Adult AML 50 mg bd at approx 12-hr intervals on days 8-21 of induction & consolidation chemotherapy cycles & then for patients in complete response bd as single agent maintenance therapy until relapse. ASM, SM-AHN & MCL 100 mg at approx 12-hr intervals continued as long as clinical benefit is observed or until unacceptable toxicity occurs.

Administration

Should be taken with food: Swallow whole w/ a glass of water. Do not open, crush or chew.

Contraindications

Hypersensitivity. Concomitant administration of potent CYP3A4 inducers (eg, rifampicin, St. John's wort, carbamazepine, enzalutamide, phenytoin).

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EX10 - midostaurin ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

POM

Presentation/Packing

Form

Rydapt cap 25 mg

Packing/Price

1's

Rydapt

midostaurin

Manufacturer:

Catalent Germany Eberbach