PKC NVR
capsule , peach , oblong oblong
Red ink
For: Acute Myeloid Leukemia, Mastocytosis
Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.
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 contains two inner packs, each with 28 capsules (7 blister cards with 4 capsules each)
112 soft capsules……………………………………………………………………………………..NDC 0078-0698-19
Contents: Each carton contains four inner packs, each with 28 capsules (7 blister cards with 4 capsules each)
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). See USP Controlled Room Temperature. Store in the original container to protect from moisture.
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 U.S. Approval: 2017
INDICATIONS AND USAGE
RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with:
Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation (1.1).
Limitations of Use:
RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.
Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). (1.2)
DOSAGE AND ADMINISTRATION
AML: 50 mg orally twice daily with food. (2.1, 2.2, 2.4)
ASM, SM-AHN, and MCL: 100 mg orally twice daily with food. (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 25 mg (3)
CONTRAINDICATIONS
Hypersensitivity to midostaurin or any of the excipients (4)
WARNINGS AND PRECAUTIONS
Embryo-fetal Toxicity: RYDAPT may cause fetal harm when administered to a pregnant woman. Advise of the potential risk to a fetus. (5.1, 8.1).
Pulmonary Toxicity: Monitor for symptoms of interstitial lung disease or pneumonitis. Discontinue RYDAPT in patients with signs or symptoms of pulmonary toxicity. Fatal cases have occurred. (5.2)
ADVERSE REACTIONS
AML: The most common adverse reactions (≥ 20%) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, and upper respiratory tract infection. (6.1)
ASM, SM-AHN, or MCL: The most common adverse reactions (≥ 20%) were nausea, vomiting, diarrhea, edema, musculoskeletal pain, abdominal pain, fatigue, upper respiratory tract infection, constipation, pyrexia, headache, and dyspnea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 and/or at https://psi.novartis.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase exposure to midostaurin and its active metabolites. Consider alternative therapies that do not strongly inhibit CYP3A4 or monitor for increased risk of adverse reactions. (7.1)
Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and its active metabolites. (7.1)
USE IN SPECIFIC POPULATIONS
Lactation: Advise females not to breastfeed (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2019
