RYDAPT SOFT CAPSULE 25MG [SIN15518P]

Product Info

RYDAPT SOFT CAPSULE 25MG

[SIN15518P]

INDICATIONS

RYDAPT is indicated:

• in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (see CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).

DOSAGE REGIMEN AND ADMINISTRATION

Treatment with RYDAPT should be initiated by a physician experienced in the use of anticancer therapies.

Before taking midostaurin, AML patients must have confirmation of FLT3 mutation using a validated test.

Dosage regimen

Target population

Recommended dose in AML

The recommended dose of RYDAPT is 50 mg twice daily. RYDAPT is dosed on days 8-21 of induction and consolidation chemotherapy cycles and then for patients in complete response twice daily as single agent maintenance therapy until relapse. In the clinical study, maintenance therapy was continued for up to 12 cycles of 28 days each. In patients receiving a haematopoietic stem cell transplant (SCT) Rydapt should be discontinued 48 hours prior to the conditioning regimen for SCT.

Recommended dose in ASM, SM-AHN and MCL

The recommended starting dose of RYDAPT is 100 mg twice daily.

Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.

Dose modifications

Dose modifications in AML

Recommendations for dose modifications of RYDAPT in patients with AML are provided in Table 1.

Dose modifications in ASM, SM-AHN and MCL

Recommendations for dose modifications of RYDAPT in patients with ASM, SM-AHN and MCL are provided in Table 2.

Special populations

Renal impairment

No dose adjustment is required for patients with mild or moderate renal impairment. Clinical experience in patients with severe renal impairment is limited. No data are available in patients with end-stage renal disease (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required in patients with mild, moderate or severe (Child-Pugh A, B or C) hepatic impairment (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatric patients (below 18 years)

The safety and efficacy of RYDAPT in pediatric patients (0 to less than 18 years) have not been established (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Rydapt should not be used in combination with intensive pediatric AML combination chemotherapy regimens including anthracyclines, fludarabine and cytarabine (see sections WARNINGS AND PRECAUTIONS and CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatric patients (65 years or above)

No dosage regimen adjustment is required in patients over 65 years of age (SEE SECTION CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Clinical studies in AML with RYDAPT did not include sufficient numbers of patients aged 60 years and over to determine whether they respond differently from younger patients. There is limited experience with midostaurin in AML patients aged 60–70 years and no experience in AML patients above 70 years. In patients aged ≥60 years, RYDAPT should be used only in patients eligible to receive intensive induction chemotherapy with adequate performance status and without significant comorbidities.

Method of administration

RYDAPT should be taken orally, twice daily at approximately 12-hour intervals. RYDAPT should be taken with food to reduce the risk of nausea and vomiting (see section CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Prophylactic anti-emetics should be administered in accordance with local medical practice as per patient tolerance.

RYDAPT capsules should be swallowed whole with a glass of water. RYDAPT capsules should not be opened, crushed or chewed.

If a dose is missed, the dose should not be made up and the patient should only take the next scheduled dose at the scheduled time.

If vomiting occurs, the patient should not take an additional dose of RYDAPT but should take the next scheduled dose.

Monitoring during treatment with Rydapt

Interval assessments of QT by ECG should be considered if Rydapt is taken concurrently with medicinal products that can prolong the QT interval.

CONTRAINDICATIONS

RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to any of the excipients.

Concomitant administration of potent CYP3A4 inducers, e.g. rifampicin, St. John’s Wort (Hypericum perforatum), carbamazepine, enzalutamide, phenytoin (see section INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).