Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Store in the original package to protect from moisture.
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, or shortness of breath [see Warnings and Precautions (5.2)].
Gastrointestinal Adverse Reactions: Inform patients that RYDAPT can cause nausea, vomiting, and diarrhea. Advise patients to contact their healthcare provider if these symptoms occur or are persisting despite supportive medications [see Adverse Reactions (6.1)].
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RYDAPT and for at least 4 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with RYDAPT and for 4 months after the last dose [see Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed during treatment with RYDAPT and for at least 4 months after the final dose [see Use in Specific Populations (8.2)].
Infertility
Advise females and males of reproductive potential that RYDAPT may impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
T2017-53
PATIENT PACKAGE INSERT
PATIENT INFORMATION
RYDAPT® (rye-dapt)
(midostaurin)
capsules
What is RYDAPT?
RYDAPT is an oral prescription medicine used to treat adults:
with newly diagnosed with a certain type of acute myeloid leukemia (AML), in combination with certain chemotherapy medicines
Your healthcare provider will perform a test to make sure RYDAPT is right for you.
with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL)
It is not known if RYDAPT is safe and effective in children.
Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT. See the end of this leaflet for a complete list of ingredients in RYDAPT.
Signs and symptoms of an allergic reaction to RYDAPT have included trouble breathing, flushing, chest pain, throat tightness, and swelling of your lips, mouth, or throat. Get medical help right away if you have any of these signs or symptoms.
Before you take RYDAPT, tell your healthcare provider about all of your medical conditions, including if you:
have any lung or breathing problems
are pregnant or plan to become pregnant. RYDAPT may cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with RYDAPT or think you may be pregnant.
If you are able to become pregnant, your healthcare provider may perform a pregnancy test within 7 days before you start RYDAPT.
Females who are able to become pregnant should use effective birth control (contracept