Label: RYDAPT capsule, liquid filled

  • NDC Code(s): 0078-0698-02, 0078-0698-19, 0078-0698-51, 0078-0698-99
  • Packager: Novartis Pharmaceuticals Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 23, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use RYDAPT safely and effectively. See full prescribing information for RYDAPT. RYDAPT® (midostaurin) capsules, for oral use - Initial ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Acute Myeloid Leukemia - RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Patient Selection - Select patients for the treatment of AML with RYDAPT based on the presence of FLT3 mutation positivity [see Clinical Studies (14)]. Information on FDA-approved tests for ...
  • 3 DOSAGE FORMS AND STRENGTHS
    25 mg capsules: pale orange oblong soft capsule with red ink imprint ‘PKC NVR’.
  • 4 CONTRAINDICATIONS
    RYDAPT is contraindicated in patients with hypersensitivity to midostaurin or to any of the excipients [see Description (11)]. Hypersensitivity reactions have included anaphylactic shock, dyspnea ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Embryo-Fetal Toxicity - Based on its mechanism of action and findings from animal reproduction studies, RYDAPT may cause fetal harm when administered to pregnant women. In animal studies ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the labeling: Pulmonary Toxicity [see Warnings and Precautions (5.2)] 6.1 Clinical Trials Experience - Because clinical ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs on RYDAPT - Table 6 lists the potential effects of the coadministration of strong CYP3A modulators on RYDAPT. Table 6: Drug Interactions with RYDAPT That Affect ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to RYDAPT during pregnancy. Females who may have been ...
  • 11 DESCRIPTION
    Midostaurin is a kinase inhibitor for oral use. The molecular formula for midostaurin is C35H30N4O4. The molecular weight is 570.65 g/mol. The chemical name of midostaurin is Benzamide ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Midostaurin is a small molecule that inhibits multiple receptor tyrosine kinases. In vitro biochemical or cellular assays have shown that midostaurin or its major human ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity studies have not been performed with midostaurin. Midostaurin was not mutagenic in vitro in the bacterial reverse ...
  • 14 CLINICAL STUDIES
    14.1 Acute Myeloid Leukemia - Study 1 - RYDAPT in combination with chemotherapy was investigated in a randomized, double-blind placebo-controlled trial of 717 patients with newly-diagnosed ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    RYDAPT 25 mg capsules - Pale orange oblong soft capsule with red ink imprint ‘PKC NVR’; available in: 56 soft capsules………………………………………………………………………………………NDC 0078-0698-99 - Contents: Each carton ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Pulmonary Adverse Reactions - Inform patients to seek medical attention for new cough, chest discomfort ...
  • PATIENT PACKAGE INSERT
    This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: November 2021 - PATIENT INFORMATION - RYDAPT ...
  • PRINCIPAL DISPLAY PANEL
    Rydapt® NDC 0078-0698-99 - (midostaurin) Capsules - 25 mg - Rx only - 56 soft capsules - Contents: 2 packs containing 28 capsules each - NOVARTIS
  • INGREDIENTS AND APPEARANCE
    Product Information