Rydapt

Rydapt Dosage/Direction for Use

midostaurin

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Treatment with RYDAPT should be initiated by a physician experienced in the use of anticancer therapies.
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 twice daily as single agent maintenance for 12 months.
Recommended dose in Advanced SM: 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 4. (See Table 4.)

Click on icon to see table/diagram/image

Dose modifications in Advanced SM: Recommendations for dose modifications of RYDAPT in patients with Advanced SM are provided in Table 5. (See Table 5.)

Click on icon to see table/diagram/image

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 Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild or moderate (Child-Pugh A or B) hepatic impairment. No study has been completed in patients with severe (Child-Pugh C) hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
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 Pharmacology: Pharmacokinetics under Actions).
Geriatric patients (65 years or above): No dosage regimen adjustment is required in patients over 65 years of age (see Pharmacology: Pharmacokinetics under Actions).
Method of administration: RYDAPT should be taken orally, twice daily at approximately 12 hour intervals. RYDAPT should be taken with food to help prevent nausea (see Pharmacology: Pharmacokinetics under Actions).
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.
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